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Promotion of regulated products using social media: an industry view

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PROMOTION OF REGULATED PRODUCTS USING SOCIAL MEDIA:
AN INDUSTRY VIEW

Kwabena A. Dankwah

A Dissertation Presented to the
FACULTY OF THE USC SCHOOL OF PHARMACY
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF REGULATORY SCIENCE

March 2015
Copyright 2015 Kwabena A. Dankwah
2
DEDICATION
This thesis is dedicated to my wife and kids, Linda, Duchess and Preston, who
encouraged me throughout my Master’s and Doctoral programs and who were always
very understanding and supportive of my aspiration to complete this work.
3
ACKNOWLEDGEMENTS
This book represents years of work on theories of regulatory. I would like to thank
everyone who supported and encouraged me throughout my doctoral studies and
everyone who helped make this dissertation a reality. My indebtedness extends to my
thesis committee for their provocative input and guidance. My inspiration was my main
professor, Dr. Frances Richmond during my doctoral studies – her research findings,
teachings and exploration shaped much of my work in the USC Regulatory Science
Program. Her knowledge, expertise and critical thinking, advice and patience are
valuable. I am also appreciative of my colleagues, Arul Sterlin and Michelle Ricafort for
their input on this topic. Special thanks also to the Regulatory Science Faculty and Staff,
particularly: Gerald Loeb, MD, Michael Jamieson, DRSc; Randa Issa PhD and Erin
Chow. And finally, I would like to thank my fellow students in the 2010 doctoral class
for their support and encouragement over years.
4
TABLE OF CONTENTS
DEDICATION .................................................................................................................... 2
ACKNOWLEDGEMENTS ................................................................................................ 3
LIST OF TABLES .............................................................................................................. 8
LIST OF FIGURES ............................................................................................................ 9
ABSTRACT ...................................................................................................................... 14
CHAPTER 1: OVERVIEW OF THE STUDY .......................................................... 16
1.1 Introduction ................................................................................................... 16
1.2 Statement of the Problem .............................................................................. 18
1.3 Purpose of the Study ..................................................................................... 20
1.4 Importance of the Study ................................................................................ 21
1.5 Limitations, Delimitations, Assumptions ...................................................... 22
1.6 Definitions ..................................................................................................... 23
CHAPTER 2: LITERATURE REVIEW ................................................................... 29
2.1 Historical Development of Rules Governing DTC Advertisement ............... 29
2.1.1 Changing Patterns of FDA Communication ................................................. 37
2.1.2 Freedom of Speech versus Consumer Protection .......................................... 38
2.2 Social Media as a Disruptive Technology for Product Promotion ................ 43
2.2.1 Pervasiveness ................................................................................................ 50
5
2.2.2 Interactivity ................................................................................................... 53
2.2.3 Trust .............................................................................................................. 55
2.3 Challenges Presented by Social Media for Medical Product Promotion....... 56
2.4 Views of Stakeholders with regard to Social Media ..................................... 59
2.4.1 The Patient..................................................................................................... 61
2.4.2 Advocacy Groups .......................................................................................... 62
2.4.3 The Health Care Professional ........................................................................ 64
2.4.4 The Regulators .............................................................................................. 68
2.4.5 The Food and Drug Administration .............................................................. 69
2.4.6 Draft Guidances on the use of Social Media ................................................. 75
2.4.6.1 Fulfilling Regulatory Requirements for Postmarketing Submissions of
Interactive Promotional Media for Prescription Human and Animal Drugs
and Biologics ................................................................................................. 75
2.4.6.2 Platforms with Character Space Limitation .................................................. 76
2.4.6.3 Sponsor Corrections of Misinformation ........................................................ 77
2.4.7 Federal Trade Commission ........................................................................... 79
2.4.8 The Industry Perspective ............................................................................... 81
2.4.9 Materials from trade associations .................................................................. 82
2.4.10 Views expressed at FDA hearings ................................................................. 83
2.4.11 Articles in Journals and Trade Press ............................................................. 86
2.4.12 Current Status of Industry Promotional Activities ........................................ 87
6
2.4.13 How Industry is Coping ................................................................................ 88
2.5 Frameworks for Research .............................................................................. 92
CHAPTER 3: METHODOLOGY ............................................................................. 97
3.1 Introduction ................................................................................................... 97
3.2 Development of Initial Survey ...................................................................... 97
3.3 Survey Deployment and Analysis ................................................................. 99
CHAPTER 4: RESULTS ......................................................................................... 101
4.1 Results of Focus Group ............................................................................... 101
4.2 Analysis of Survey Respondents ................................................................. 103
4.2.1 Profiles of Respondents ............................................................................... 103
4.3 Safety and Effectiveness Response ............................................................. 122
4.4 Level Playing Field ..................................................................................... 125
4.5 Access ......................................................................................................... 128
4.6 Compliance.................................................................................................. 129
4.7 FDA Proposed Draft Guidance on Social Media ........................................ 134
4.8 Cross-Tabulations ........................................................................................ 139
CHAPTER 5: DISCUSSION ................................................................................... 141
5.1 Introduction ................................................................................................. 141
5.2 Methodological Considerations ................................................................... 141
5.2.1 Sampling Plan ............................................................................................. 141
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5.2.2 The Survey as a Research Tool ................................................................... 144
5.2.3 Validity of Survey Questions ...................................................................... 146
5.3 Current Status of Promotion through Social Media .................................... 148
5.4 Do Current Regulations Achieve the Aims of Regulation? ........................ 155
5.4.1 Do the regulations heighten safety? ............................................................ 155
5.4.2 Do the Regulations Level the Playing Field? .............................................. 158
5.4.3 Do regulations slow access or reduce competitiveness? ............................. 160
5.4.4 Compliance.................................................................................................. 162
5.5 Future Research and Conclusion ................................................................. 169
REFERENCES ............................................................................................................... 173
APPENDIX A ................................................................................................................. 197
APPENDIX B ................................................................................................................. 209
APPENDIX C ................................................................................................................. 310

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LIST OF TABLES
Table 1: Definitions .......................................................................................................... 23
Table 2: Summary of information from FDA hearing on social media (FDA, 2009d) .... 84
Table 3: Examples of pharmaceutical companies’ social media sites .............................. 89
Table 4: Focus Group Agenda .......................................................................................... 99
Table 5: What does your company do with data from social media? Please explain.
(Selected responses shown by response type). ................................................ 119
Table 6: What are your views as the business advantages associated with
participating in social media? Please explain. (Selected responses shown by
response type). ................................................................................................. 121

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LIST OF FIGURES
Figure 1: Use of the internet for health continues to rise. Modified from (Ressi, 2011) .. 48
Figure 2: Percentage of consumers viewing health information through social media.
Modified from (Barnes et al., 2012) ................................................................. 49
Figure 3: Use of social media platforms. Modified from (Vollmer & Premo, 2011) ....... 50
Figure 4: Social networking site (SNS) use by online adults, 2005-2011. Modified
from (Zickuhr & Madden, 2012) ...................................................................... 51
Figure 5: SNS use on a typical day by age group, 2005-2011. Modified from
(Zickuhr & Madden, 2012) .............................................................................. 52
Figure 6: Key social media interactions among patients, physicians, and the public.
Modified from (Chretien & Kind, 2013) .......................................................... 54
Figure 7: Likelihood to trust or share information via social media.
(Barnes et al., 2012) ......................................................................................... 55
Figure 8: Average number of consumers who talked with a physician about specific
medicine that was advertised. Modified from (Carlson, 2011) ........................ 67
Figure 9: Framework for current research ........................................................................ 93
Figure 10: What title is aligned most closely with your current responsibility? ............ 104
10
Figure 11: What is your job function? Please choose the best answer ........................... 105
Figure 12: Which group in your current organization controls social media
promotional review and approval? ................................................................ 106
Figure 13: What is your company's annual revenue (in U.S. $)? ................................... 107
Figure 14: In which product categories are you involved? ............................................. 108
Figure 15: Other than social media, which media channels do you use for Direct to
Consumer Advertising (DTC)? Please check all that apply ......................... 109
Figure 16: What is your level of involvement with regard to promotional activities
using social media? Please check all that apply............................................ 110
Figure 17: If you are using social media, please check all of the channels that apply ... 111
Figure 18: Does your company use or plan to use social media in the following
areas to engage customers? ........................................................................... 112
Figure 19: What core objectives does your company consider when deciding to
proceed with social media promotion? Please rank with most preferred
item on the top .............................................................................................. 113
Figure 20: In your experience, which statement best describes your company's
participation in social media in the last 2 years? .......................................... 114
Figure 21: If you chose major increase, what was the reason? ....................................... 115
11
Figure 22: How important are the following challenges with respect to the
commercial use of social media. Please rank the following from most
important to least important. ......................................................................... 116
Figure 23: Please rank the importance that your company places on the following
in the uses of social media from most to least important with 1 being
the most important. ....................................................................................... 117
Figure 24: As a vehicle for consumers to receive timely information on product
safety, how would your company rank the following channels for
dissemination of information with 1 being the most timely? ....................... 118
Figure 25: As a vehicle for consumers to receive reliable information on product
safety, how would your company rank the following channels for
dissemination of information with 1 being the most reliable? ...................... 118
Figure 26: Which of the following concerns would influence your decisions
regarding the ways that your company use social media? ............................ 123
Figure 27: Of the following choices, which do you think is best suited to provide a
balanced presentation of both risks and benefits of medical products? ........ 124
Figure 28: Do you think that regulations that currently restrict company use of social
media deprive patients of important safety & efficacy information? ........... 125
12
Figure 29: How would your company most likely deal with a situation in which it
discovered that a competitor was not compliant with DTC rules? ............... 126
Figure 30: "The FDA issues enforcement actions more frequently against large
companies versus small companies" Do you agree with this statement? ..... 127
Figure 31: Which social media forums do you view as the most effective in
promoting your product, with 1 being the most effective? ........................... 128
Figure 32: In your company's view, how likely is it that your company will increase
social media spending over the next 3 years? ............................................... 129
Figure 33: Do you have a written procedure governing the use of social media? .......... 130
Figure 34: Some have suggested that promotion by social media should be governed
by an entity other than the FDA. Which group(s) would you prefer to
oversee advertisement and promotion using social media? .......................... 131
Figure 35: Do you think that it is feasible for industry to monitor social media for
adverse events? ............................................................................................. 132
Figure 36: How should FDA regulate social media interactions by agents of the
company? ...................................................................................................... 133
Figure 37: If you chose "No", which of the following allows industry to fulfill the
adequate provision requirements?................................................................. 134
13
Figure 38: FDA has recently released the proposed guidance for "Fulfilling
Regulatory Requirements for Postmarketing Submissions of Interactive
Promotional Media for Prescription human and Animal Drugs and
Biologics". Are you familiar with the guidance? ......................................... 135
Figure 39: What is your view on the following statements? .......................................... 136
Figure 40: Please rate your agreement or disagreement with the following
statements? .................................................................................................... 137
Figure 41: Which of the following areas does your company find problematic?
Please check all that apply. ........................................................................... 138
Figure 42: What is your view about the overall impact of the guidance document in
assessing the regulatory risk of continuing or initiating the use of social
media platforms in the medical industry? ..................................................... 139

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ABSTRACT
In August 1997, the Food and Drug Administration (FDA) announced rules to govern
promotion directly to the consumer (DTC), the results of which were to permit branded
broadcast advertising. These rules defined promotion broadly, as any information and/or
materials distributed by a medical products company. Materials and conversations
through social media fit under this definition. However, the nature of social media
presents unique challenges for the regulatory system both because of its prevalent use and
its novel communication structure, in which two way interactions with consumers are
possible. This exploratory study examines the views of industry professionals using a
survey approach based on four key elements of theory of regulation: 1) to ensure the
safety and effectiveness of medical products, 2) to improve access to useful medical
products and associated information, 3) to use compliance as a regulatory instrument or
policy, 4) to assure a level playing field. Respondents were primarily employed in
regulatory or marketing functions in medical device and pharmaceutical companies and
working with social media as a way to promote or educate consumers about medical
products. Results suggested that social media channels were already being used
extensively to engage consumers and healthcare professionals in providing health
information. Respondents identified building awareness was one of the key objectives in
engaging in social media, and several other uses were also identified. However,
restrictions aimed at aligning promotional rules with those of traditional media appear to
handicap the full use of this new channel. Results suggest that certain current approaches
to fit the regulation of social media into a traditional framework may restrict the
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interaction of companies with users in ways that diminish the potential use of social
media without greatly enhancing patient protections.
16

CHAPTER 1: OVERVIEW OF THE STUDY
1.1 Introduction
Since 1938, when the Food Drug and Cosmetic Act (FD&C) defined misbranding as an
offense, medical product companies have struggled to ensure that their products comply
with advertising and promotion requirements of the United States of America (US) Food
and Drug Administration (FDA). Such compliance has become particularly challenging
in the last decade as new channels for communicating about medical products have
become available outside of conventional print and broadcast media. Perhaps the most
powerful and contentious set of channels are those collectively considered as "Social
Media". “Social Media” is a broad term describing the free and open communication that
can take place using mobile and internet tools to share content, personal profiles,
opinions, insights, experiences and perspectives. Andreas Kaplan and Michael Haenlein
define social media as a “group of internet-based applications that build on the
ideological and technological foundations of Web 2.0, and that allow the creation and
exchange of User Generated Content" (Kaplan & Haenlein, 2010).
However, this new channel of communication differs significantly from traditional
channels that serve as the foundation for FDA’s rules regarding promotion of medical
products. FDA classifies print and broadcast media into three types of Direct-to-
Consumer (DTC) advertisements: 1) reminder advertisements that do not reference the
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drug’s purpose, benefits, or risks, and that refer to the drug’s brand name only, 2) help-
seeking advertisements that contain information about a disease or medical condition
without mentioning the drug’s brand name, and 3) product-claim advertisements that
include both the brand name and the major risks posed by the drug (FDA, 1995).
Product-claim ads are the most common and controversial type of DTC advertising and
are the ones regulated most carefully by the FDA.
The FDA has adopted a broad interpretation of promotional labeling. It defines labeling
to include ANY materials distributed by or on behalf of a restricted medical device or
pharmaceutical company or ANY event sponsored by or on behalf of the company that
mention one or more of its products. The materials therefore go beyond written materials
to include oral presentations, remarks and one-on-one detailing information
communicated to the customer. Yet in the last ten years, this already generous
interpretation still may not be broad enough. The implicit assumption that underlined
previous understanding of promotional communication was its “one-way” nature. Social
media gives a new ability to permit “two-way” communication, by allowing recipients of
the promotional message to respond to those messages. Companies and legislators have
expressed concern that new standards and guidelines may be needed to guide the use of
social media in product promotion and advertising, and to manage the dissemination of
incorrect information, often from non-company sources. The goal of such new guidance
would be to ensure that the “two-way” messaging has the fair balance needed to prevent
serious adverse consequences for patients and health care professionals who might be
misled. Presently, that need is unmet because no final FDA guidance exists to assist
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companies who wish to use social media to promote the use of their drugs or medical
devices. Until this year, companies were left to interpret appropriate behavior from the
general regulations that were promulgated to define the content requirements of
prescription drug advertising and labeling.
FDA’s recent release of their three draft guidance documents has marked a major shift in
the development of regulatory thought with respect to social media. It outlined how
manufacturers and their representatives would be allowed to communicate online about
prescription drugs and medical devices within the boundaries of the law. Thomas
Abrams, Director, The Office of Prescription Drug Promotion (OPDP, formerly Division
of Drug Marketing, Advertising and Communications - DDMAC) stated that the FDA
developed these new guidances, in part, to respond to requests for best practices from
companies and other stakeholders. Abrams reported that FDA gave careful thought to
their draft recommendations and worked across FDA Centers and Offices to develop best
practices that can be applied to existing online Internet sites. Abrams also noted that
technology will continue to evolve, and in doing so, guidance would have to anticipate
internet sites and methodologies that have yet to be developed (Abrams, 2014).
1.2 Statement of the Problem
Medical product companies want, and indeed should be able to use social media.
However, unlike other industries which can easily promote their products through all
channels, pharmaceutical and medical device companies have many restrictions on their
promotional speech. Social media is a particularly promising avenue for medical product
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promotion, yet companies cannot operate freely due to the many restrictions that
currently exist to regulate advertising and promotion. Therefore, pharmaceutical
companies are challenged to identify ways of using digital communications whilst
complying with this restriction. Industry's interpretation of appropriate versus
inappropriate use of social media as a marketing tool is usually only validated when
enforcement actions are taken against companies accused of violating the regulations.
Such actions help industries define the boundaries of appropriate actions, but the lessons
learned are generally retrospective and incomplete. Because draft guidance are by their
nature unfinished, companies may lack a clear picture of the boundaries for social media
marketing as the guidance is developing. Once complete, the guidelines may then
impose strict interpretations of the law that restrict unnecessarily the use of these novel
interactive tools. In particular, current FDA regulations on drug advertising fail to take
into account the realities of the two-way communication permitted by social media, an
advance that truly disrupts the way that promotion has been regarded over the last
century.
Anecdotal evidence suggests that the lack of guidance is frustrating companies who are
anxious about the potential liability of presumptive off-label promotion and the
challenges of meeting requirements for risk disclosure and adverse event (AE) reporting.
However, we do not have a clear picture of the priorities and concerns that medical-
product companies have regarding the use of social media for promotional activities.
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1.3 Purpose of the Study
The purpose of this exploratory research is to study the impact of direct-to-consumer
advertising on the use of social media by the medical products industry. I used the
modified triad of constituents associated with policy making as enunciated by Redington
(Redington, 2009) as a framework to explore the degree to which current medical-
product regulations are viewed to : 1) protect the public by assuring that prescription drug
information is truthful, balanced, and accurately communicated to support the safety and
effectiveness of medical products, 2) facilitate efficiencies in the management of
research, commercialization, and life-cycle management, and 3) to equalize requirements
and standards for different industry competitors and players. A fourth dimension has
been added to this triad: 4) to examine the regulation of social media with regard to the
ability to exercise fair and balanced oversight and to ensure compliance. A survey tool
was developed to: (a) probe the industry on specific views related to the adequacy of
FDA policies for regulation of medical products and more general views regarding the
potential influences that they see which might transform, contribute or hinder the
development of effective policies or guidance; (b) explore industry’s views with respect
to the effectiveness of the current guidance.
The survey tool was critiqued by a focus group of individuals with experience in
advertising and promotion of medical products or with development of industry policy. It
was then administered electronically to a selected group of industry participants with
significant experience in the development and dissemination of social media information.
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A particular effort was made to ensure that the voices of medical device industries were
heard because this subgroup has traditionally been ignored in considerations of social
media use in this sector.
1.4 Importance of the Study
The opportunity for drug manufacturers to advertise directly to the consumer using the
internet has generated controversy among legislators, health care professionals,
regulatory organizations, ad experts, and consumer advocates. The goal of this project is
to contribute to the body of knowledge that industry and regulatory bodies can use to
develop policies that govern social media promotion in ways that achieve the objectives
of such regulation.
This research study will help bring awareness about the types and magnitudes of hurdles
faced by the medical device industry when considering the use of social media. A better
understanding of these potential barriers may ultimately improve the ways in which
restrictions on product promotion using social media are applied, either through changes
in regulation or its associated interpretation by regulatory agencies such as the FDA. By
recognizing that any interventions by regulators may affect not only patient safety but
also commercial considerations such as efficiency and fairness in the marketplace, policy
development would be less likely to sacrifice one objective in the pursuit of another.
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1.5 Limitations, Delimitations, Assumptions
This study is delimited in time and scope. The study is delimited to the evaluation of
DTC advertising in the US. This environment is one in which no final guidance currently
exists on use of social media for medical products’ advertising and promotion. Other
countries have guidelines and regulations that may be different and instructive to this
topic. The geographic delimitation of this survey has the potential to bias responses to
those who generally have more experience with US regulations. The results may also be
influenced by the narrow snapshot of the research period; they may be swayed by
changes in the regulatory environment (e.g., enforcement actions, litigation, issuance of
new regulatory authority guidance, citizen petitions, court cases, etc.) and ongoing legal
and regulatory developments specific to the time. Regardless of the changing
environment, they will serve as a benchmark that can be used to see how views change
over time. The impact of such events, should they occur, on the survey results are
discussed as appropriate in the discussion section of this dissertation.
Notably, results of this survey might be biased because of the relatively small numbers of
respondents available to participate in this initial pilot study. As such, care must be taken
to consider the possibility that external validity may be compromised by the small sample
size. Further, the results of this study may be restricted by the availability of appropriate
individuals to be interviewed. Finally, one must assume that these individuals surveyed
in the study were candid and forthcoming in their responses.

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1.6 Definitions
Table 1: Definitions
Term Definition
Advertisement Includes information (other than labeling) that is issued
by, or on behalf of, a manufacturer, packer, or distributor
and is intended to promote a product. This includes, for
example, ‘‘advertisements in published journals,
magazines, other periodicals, and newspapers, and
advertisements broadcast through media such as radio,
television, and telephone communication systems’’.
Blogs Web sites with regular updates (in reverse chronological
order—newest update at the top) that typically combine
text, images (graphics or video), and links to other Web
pages. Blogs are usually informal and take on the tone of
a diary or journal entry. Some blogs are very personal,
while others provide mainstream news updates. Most
blogs encourage dialogue by allowing their readers to
leave comments.
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Term Definition
DTC

Direct to Consumer
External Sponsored Social
Media
External company-sponsored or company-hosted online
environments and applications is used to facilitate sharing
content, profiles, opinions, insights, experiences and
perspectives among the general public.
Fair Balance The presentation of true information relating to side
effects and contraindications is comparable in depth and
detail with the claims for effectiveness or safety.
Internal Social Media Online tools that employees use to share content, profiles,
insights, experiences, media and perspectives with the
goal of enhancing business efficiency through
collaboration. Examples include discussion forums, and
blogs authored and read only by employees.
Labeling ‘‘All labels and other written, printed, or graphic’’
materials ‘‘upon’’ or ‘‘accompanying’’ an article (FDA,
2009c).
25
Term Definition
Social Media Extranet Online tools that employees and external business
partners use to share content, profiles, insights,
experiences and perspectives with the goal of enhancing
business efficiency through collaboration outside
companies firewall, but not publicly available. Examples
include interactive password protected websites for
employees and marketing agencies, external research
partners and consultants with functionality such as
discussion forums and blogs.
Microblogs Comprised of extremely short written blog posts, similar
to text messages, and provide real-time updates. Twitter
is an example of a popular microblog service that lets
users broadcast short messages up to 140 characters long
(‘‘tweets’’) using computers or mobile phones (FDA,
2009c).
26
Term Definition
Monitoring System A process for listening, evaluating and determining
whether or not to respond to issues, messages and/or
commentary. Monitoring Systems are tools to identify
and measure business insights, as well as manage risks
that threaten reputation.
News Outlet Social Media
Sites
Social media presence of mainstream/traditional news
outlets (i.e. BBC, CNN), which may include activity on
third-party sites such as Facebook, Twitter, YouTube, as
well as discussion forums on their own Web sites where
comments may be posted.
Off Label Promotion Any use of information or data related to uses of a
product that is not consistent with the FDA
cleared/approved labeling for the product
Personal/Non-Sponsored
Social Media
Public social media outlets where company employees,
contractors, consultants and agents act in their
individual/personal capacity when referring to company,
not as employees or agents of the company.
27
Term Definition
Podcasts Audio or video files that users can listen to or watch on
computers or on a variety of portable media devices (like
an iPod, Zune, and certain cell phones). Podcasts are
usually short and often free, and users can arrange via
subscription to receive new podcasts automatically via
their computers or other media devices.
Social Media Project Owner The single point of contact identified as the responsible
person for a social media project in the company.
Social networks and online
communities
Give users opportunities to connect with or provide
resources to clients, colleagues, family, and friends who
share common interests. In many social networks, users
create profiles and then invite people to join as
‘‘friends.’’ There are many different types of social
networks and online communities, many of which are
free, and they range from general to those tailored for a
specific demographic or interest area.
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Term Definition
Video sharing Allows individuals to upload video clips to an internet
Web site. The video host will then store the video on its
server and show the individual different types of code to
allow others to view or comment on the video.
Widgets A graphic control on a Web page that allows the user to
interact with it in some way. Widgets can also be easily
posted on multiple Web sites, have the added benefit of
hosting ‘‘live’’ content, and often take the form of on-
screen tools (clocks, event countdowns, auction tickers,
stock market tickers, flight arrival information, daily
weather, etc.) .
Wikis Creates a Web page that anyone with access can
modify—quickly and easily. A wiki can be either open or
closed, depending on the preferences of the community
using it. An open wiki allows anybody to make changes
and view content. A closed wiki allows only community
members to make changes and view its content. Some
wikis allow anyone to view content but only members to
edit the content.
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CHAPTER 2: LITERATURE REVIEW
2.1 Historical Development of Rules Governing DTC Advertisement
The practice of advertising drug products directly to consumers has had a long history in
the United States. During the 18th and 19th centuries, patent medicines—presumptive
drug compounds with colorful names—were advertised in newspapers, often with
misleading and deceptive claims. By the early 20th century, advertisements for patent
medicines accounted for approximately 50% of newspapers’ advertising revenue.
Marketing of medical products was completely unregulated until 1906, when Congress
passed the Pure Food and Drug Act. This law, however, had minimal impact on
deceptive advertising practices because it was directed primarily at the truthfulness of
drug product labels (Schwartz, Silverman, Hulka, & Appel, 2009). Thus, it proved
inadequate to control several problematic issues associated with drug manufacture and
marketing that had serious implications for patient safety. One such issue was graphically
illustrated by the sulfanilamide tragedy in 1937, in which product formulated with
ethylene glycol killed over 100 people, mostly children (Ballentine, 1981). Despite the
severity of the problem, it proved impossible to prosecute the manufacturer of the
sulfanilamide for more than using the name “elixir” for the preparation, because the Act
prohibited such messaging unless the formulation contained alcohol. For this infraction,
the company, Massengill, paid a minimal fine.
The public outcry following the sulfanilamide tragedy spurred Congress to withdraw and
replace the Pure Food Act in 1938 with the Food Drug and Cosmetic (FD&C) Act. The
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new FD&C Act (21 U.S.C. §301) gave authority over the adulteration and misbranding of
drugs and food additives to the newly formed Food and Drug Administration (FDA) and
established the legitimacy of enforcement activities conducted by the FDA. Promotion
and labeling had a central place in the legislation because this was the area in which
misbranding problems typically were identified to occur.
The terms “label” and “labeling” are so fundamental to the regulatory construct that they
are defined specifically in the FD&C Act itself (21 U.S.C. §321(k), 21 U.S.C. §321(m)).
According to the FD & C Act, a label is
a display or written, printed, or graphic matter upon the immediate
container of any article; and a requirement made under authority of the
Act that any word, statement, or other information appearing on the label
shall not be considered to be complied with unless such word, statement,
or other information also appears on the outside or wrapper, if any other,
of the retail package of such article, or is easily legible through the
outside container or wrapper 21 U.S.C. §321(k)

Labeling is defined as “all labels and other written, printed, or graphic matter (1) upon
any article or any of its containers or wrappers or (2) accompanying such article” (21
U.S.C. 321(m). “Accompanying” is interpreted broadly by the FDA and is not limited to
that which physically accompanies the product. Labeling can be any article, printed,
electronic or spoken, which mentions the product.
The interpretation of misbranding has evolved over time as labeling promotional methods
have evolved. For the first half of the 20
th
century, the common quack medicines were
associated with claims that would be seen as extreme today, but oversight was typically
31
remiss. When attention was given, it was directed at the truthfulness and balance of only
the most flamboyant of advertising claims. The approach began to change and also
intensified in the 60s, when a series of issues, ranging from rising costs of medicines to
outrage over the unsupervised experimental use of the teratogen, thalidomide, caused the
US Congress to investigate the pharmaceutical industry. Promotional activities became a
focus when it was recognized that thalidomide, unapproved for sale in the United States,
had been distributed, under the guise of science, in order to familiarize doctors with the
use of the drug by encouraging them to conduct poorly monitored and designed “seeding
trials”. Such market-oriented clinical use led to babies with specific birth defects, such as
phocomelia and other types of bone defects.
To address these issues as part of risk mitigation efforts to prevent a similar situation
from occurring in the future, the US Congress held hearings focused on gaps in the
FD&C Act. Congress next modified the FD&C Act on October 10, 1962, through the
1962 Drug Amendments (21 U.S.C. §352), also commonly called the Kefauver-Harris
Amendments. This new legislation had several key improvements including the
requirement that all drugs be shown to be effective as well as safe. In addition, the law
broadened FDA authority over clinical trials, manufacturing and marketing of medical
products. More specifically, one section of the law, §502(n), gave the FDA explicit
authority over the advertising of prescription drugs. This new authority represented a
major shift in direction for the oversight of medical product promotion. Prior to this
time, US Congress had exempted prescription drug advertising from regulatory control
under the FD&C Act and the Federal Trade Commission Act (FTC Act) (15 U.S.C. §45,
32
15 U.S.C. §52). Through these two laws, US Congress had previously expressed their
collective view that physicians who prescribed drugs were professionals who did not
need protection from potentially misleading advertising in the way that such protections
were afforded to the general public.
A full description of the implications of the 1962 Drug Amendments on medical product
oversight is beyond the scope of the research here. However, its role in the control of
prescription product pricing and advertising is germane to the thesis. On one hand, the
Amendments brought together the concern of the legislation on the protection of patients,
and the high prices of drugs on the other. Legislators recognized that some drugs were
being promoted for unapproved purposes and that physician and consumers had no
reasonable opportunity to evaluate the accuracy of prescription drug advertising. At the
same time, the extensive advertising associated with such activities was seen to drive up
the costs of drugs. Concern was expressed regarding the lack of “fair balance”, in which
favorable features about a drug were emphasized and unfavorable aspects were
diminished.
The concern about fair balance was expressed in clause §502(n); and despite its brief and
general nature, has nonetheless become the basis of most current regulations existing in
the promotional arena today. It states that a prescription drug is misbranded unless the
manufacturer, packer or distributor includes in all “advertisements and other descriptive
printed matter” (a) the generic name, in type size at least half that of the trade name, (b)
the ingredients and (c) a brief summary of side effects, contraindications and
33
effectiveness, as dictated by regulations”. Section §502(n) of the FD&C Act also
specifically states that FDA pre-clearance of advertising shall not be required, except in
“extraordinary circumstances.” Although clause §502(n) was directed specifically at
prescription drug advertising, the provision was also adopted by the FDA Centers that
regulated prescription devices, biologics and prescription veterinary medicines.
Clause §502(n) did not define “advertising” or explain how it relates to “labeling.” Thus,
the FDA issued a number of regulations to clarify and expand on the rules by which
clause §502(n) of the FD&C Act would apply. The regulations, found in Title 21 of the
Code of Federal Regulations (CFR), specified inclusions for prescription drug
advertisements; defined different kinds of advertising, such as reminder advertisements
and price advertisements; and set forth “fair balance” requirements in prescription drug
advertising (21 CFR Part 202). It is important to note that the FDA’s drug advertising
regulations were written at a time when advertising in medical journals and face-to-face
visits to clients (so-called “detailing”) were the two most prevalent ways prescription
drugs were promoted to physicians. Interaction via this mechanism allowed the clinician
to be the “learned intermediary”, enabling them to determine the information to be shared
with the consumer/patient.
In the 1960s and 1970s, attempts to communicate directly with consumers were typically
limited to public service announcements (PSAs). The goal was to increase the public’s
awareness of certain disease states so that affected consumers would be more apt to seek
medical attention. The first clear evidence of communications to inform users about a
34
specific product first appeared in the form of the patient package insert (PPI), which
eventually became a regulatory requirement for a limited selection of drugs. The first
PPI was developed in 1968, when FDA required the insert for isoproterenol inhalation
products (33 F.R. 8812; 21 C.F.R. §201-305). This PPI, which focused on how to use
the inhalers rather than on safety concerns, represented the first time that FDA formally
recognized the value of presenting information to patients for improved understanding to
enhance benefits from the product. The FDA required PPIs to provide consumers with
safety and efficacy information (35 F.R. 9001; 21 C.F.R. §310.501) using this same
concept for birth control pills in 1970. This requirement was then extended to estrogen
products in 1977, after an association between estrogen replacement therapy and uterine
cancer was identified in a clinical study published in 1975 (21 C.F.R. §310.515). In
1980, FDA issued a regulation requiring PPIs for ten prescription drugs (45 F. R.
60,754), but revoked the regulation in 1982, in favor of a plan under which
pharmaceutical companies voluntarily provided more information about their products to
consumers (47 F.R. 39,147).
The use of PPIs ultimately encouraged industry to consider other mechanisms, including
promotional mechanisms, by which it might communicate more directly with consumers.
In the early 1980s, a few pharmaceutical manufacturers, including Boots Pharmaceutical
and Merck Sharp & Dohme, experimented with prescription drug advertisements directed
at consumers (Pines, 1999). These initiatives drove regulators and others to reconsider
the rules governing such advertisements. Initially, FDA advanced the view that DTC
advertising did not violate FDA law and regulations; but in September 1982, FDA
35
changed its position and declared a “moratorium” on DTC advertising. The moratorium
was lifted in 1985 (56 F. R. 36677). The FDA stressed that DTC advertisements must
follow the standards already in use when marketing to professionals. Print ads would
require a detailed “brief summary” of risk and other information. Broadcast
advertisements would require a much shorter, but nonetheless lengthy “major statement”
of risks, while also making “adequate provision” for viewers to obtain full FDA-
approved prescribing information. “Help-seeking” ads could discuss the fact that a
treatment existed for a condition, but could neither mention a drug by name nor make
suggestions and representations about drug treatments. “Reminder” ads could identify the
brand names of drugs but could not mention the conditions that the drugs could treat.
Guided by these limitations, expenditures on DTC advertising increased from $12 million
in 1989, to $55 million in 1991, $164 million in 1993, $340 million in 1995, and $579
million in 1996 (Pines, 1999).
In August 1997, FDA again re-examined its philosophy regarding DTC advertisement
and issued a preliminary “Guidance for Industry: Consumer-Directed Broadcast
Advertisements” that reinterpreted its regulations given the rapid growth of this mode of
communication. According to the guidance, it remained insufficient to be non-deceptive
and aligned with recommendations for advertisements directed at professionals. Such
prescription drug advertising must meet four components considered as part of what was
termed “adequate provisions”. The four required components included:
36
(a) A toll-free telephone number for consumers to call in order to request the
approved package labeling. Consumers choices included: having a
promotional piece mailed to them in a timely manner; having the material
faxed to them in a timely manner; or having the labeling read over the
phone
(b) A mechanism by which consumers with restricted access to sophisticated
technology (internet, etc.) could obtain comparable information, for
example in a print advertisement appearing concurrently in an
appropriately selected publication, or from a brochure strategically
distributed in a variety of publicly accessible sites (e.g. pharmacies,
doctors’ offices, grocery stores, and public libraries). The printed portion
of this advertisement should also include a toll-free number and address, at
which consumers can obtain the full package labeling
(c) A statement in the broadcast advertisement that pharmacists, physicians,
veterinarians (in the case of animal drugs), or other healthcare
professionals may provide additional product information to consumers
and
(d) An internet web site address in the broadcast advertisement that provides
access to the package labeling.
The FDA also encouraged sponsors of the DTC advertisement to provide consumers with
non-promotional, consumer friendly product information (e.g., FDA-approved patient
labeling).
37
Until 1976, medical devices and drugs were regulated similarly, under rules designed for
the oversight of drugs. The Medical Device Amendments of 1976 changed this when
devices became regulated under different sets of rules. The passage of the Medical
Device Amendments provided FDA jurisdiction over the regulation of advertising of
“restricted” medical devices, while the FTC retained primary responsibility for
advertising of non-restricted devices. Nevertheless, both types of products were subject
to the same misbranding requirements under the FD&C Act. Similarly, different rules
governing foods such as the Fair Packaging and Labeling Act of 1966 (15 U.S.C. §1451)
and the Nutritional Labeling and Education Act of 1990 (21 U.S.C. §301) modified some
of the specific approaches to nutritional labeling, but did not change the way in which
misbranding was interpreted under the FD&C Act.
2.1.1 Changing Patterns of FDA Communication
FDA and other government agencies typically provide information about legal
requirements to industry in one of two ways, formal regulations and informal guidance.
Formal regulations, issued through a formal rulemaking process and published in the
Federal Register and Code of Federal Regulations, become extensions of the law, and
might be termed “hard law”. This type of regulation was observed very commonly in the
latter part of the 20
th
century. “Soft law”, including guidance and pronouncements of
different types, has become more common in the last decade as a way to influence
behavior and relay FDA views (Gersen & Posner, 2008). In the case of advertising and
promotional policies, FDA’s positions can be evident, often on a case-by-case basis,
38
through public issuance of Warning Letters, guidance documents setting forth policy on
various issues, and verbal communications at industry-wide educational meetings. Such
types of guidance are more difficult for companies to interpret as they are not clearly tied
to compliance requirements, and can communicate mixed messages.
The political realities of developing and defending new regulations make it very difficult
to obtain agreement among stakeholders. Hence more informal methods are often easier
to implement. The use of “soft law” methods has been particularly common for FDA to
communicate its position on various topics, including the use of social media for
promotion and advertising, as further described below. In December 2011, the FDA
offered one piece of salient guidance titled, Draft Guidance for Industry: Responding to
Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical
Devices. Seemingly, this appeared in response to a Citizen Petition filed in 2010 on
behalf of a group of seven drug/device manufacturers (Allergan, Lilly, J&J, Novartis,
Novo Nordisk, Pfizer and Sanofi-Aventis) requesting that FDA clarify the topic of
communications with consumers rather than healthcare professionals. However, the use
of “soft-law” is rather indirect and may not provide sufficient guidance in some areas of
concern.
2.1.2 Freedom of Speech versus Consumer Protection
One to complicate the development of regulations governing promotion is the
contradiction that regulations restricting promotion may create relative to the first
39
amendment of the US constitution, the so called “First Amendment Rights”. The First
Amendment of the US Constitution of 1791 states that:
Congress shall make no law respecting an establishment of religion, or
prohibiting the free exercise thereof; or abridging the freedom of speech,
or of the press; or the right of the people peaceably to assemble, and to
petition the Government for a redress of grievances.
The First Amendment applies to speech, not conduct. As a result, a primary question in
any First Amendment claim is whether the activity being probed is speech or conduct
("Ohralik v. Ohio State Bar Assn," 1978). Upon establishing that the issue in question
concerns speech rather than conduct, First Amendment jurisprudence creates several
levels of protection for different kinds of speech, including scientific and commercial
speech. However, commercial speech is afforded less protection than non-commercial
speech under the First Amendment ("Washington Legal Foundation v. Friedman," 1998).
The differentiation of commercial versus non-commercial speech can be difficult to
define. It would appear that FDA developed its regulation governing promotional speech
without much consideration to First Amendment protection of commercial
communications. In particular, it seemed to contravene case law that arose from a
number of judicial rulings on commercial speech that were first recognized in the
Supreme Court’s 1976 Virginia Pharmacy decision ("Va. Pharmacy Bd. v. Va. Consumer
Council," 1976). In this case, the Virginia Citizens Consumer Council, acting on behalf
of prescription drug consumers, challenged a Virginia statute declaring that
advertisement of prescription-drug prices by licensed pharmacists constituted
unprofessional conduct. On May 1976, the U.S. Supreme Court decided in favor of the
40
Virginia Citizens Council and upheld a lower court’s injunction barring the state of
Virginia from enforcing this type of prohibition. The Court held that the First
Amendment protects willing speakers and willing listeners equally. It noted that in cases
of commercial speech, such as price advertising, freedom of speech protections apply just
as they would to non-commercial speech. The Court further concluded that although the
Virginia State Board of Pharmacy had a legitimate interest in preserving professionalism
among its members, it may not do so at the expense of public knowledge about lawful
competitive pricing terms.
Given the latter discussion, it is perhaps not surprising then, that FDA regulations on
promotion have been challenged on different occasions. One of the most successful
attempts was that filed in 1993 by the Washington Legal Foundation (WLF), a public
interest and policy center, in a citizen petition that challenged the constitutionality of the
FDA’s policies relating to the education of consumers. In its petition, the WLF asserted
that FDA policy violated the First Amendment rights of drug, device and biologics
companies to disseminate truthful information about unapproved uses for their products
during medical education symposia, as well as the rights of physicians to receive such
information. The district court essentially overturned FDA’s position restricting
companies from disseminating any article previously published in a bona fide peer-
reviewed professional journal, or any reference textbook or excerpt of a reference
textbook published by a bona fide independent publisher, to physicians or other medical
professionals. Rather, the district court concluded that the disclaimers on the articles were
sufficient ("Washington Legal Foundation v. Friedman," 1998).
41
Conversely, the courts, including the Supreme Court, have repeatedly upheld FDA’s
broader authority to limit commercial speech as part of promotional activities. The few
FDA regulations that have been challenged on First Amendment grounds have generally
failed to withstand judicial scrutiny ("Pearson v. Shalala," 1999; "Thompson v. Western
States Medical Center," 2002; "Washington Legal Foundation v. Friedman," 1998). In
response to FDA’s May 16, 2001, Federal Register notice, Calfee argued that:
The institutional setting in which FDA advertising regulation occurs has
forestalled legal challenges by manufacturers. At the same time, FDA has
strong incentives to construct very strict regulations so as to insulate the
staff from criticism for possibly inappropriate advertising and promotion.
This suggests that many of the core features of FDA’s regulation of
commercial speech and other communications by pharmaceutical
manufacturers are probably far too stringent to be consistent with First
Amendment law (Calfee, 2002)
Given the attempts to limit FDA’s authority were so often unsuccessful, it surprised many
that the very recent case of United States v. Caronia successfully challenged FDA’s
position. In this case, Caronia, a specialty sales consultant, was convicted in federal court
in Brooklyn, N.Y., for promoting the drug Xyrem for uses not approved by the FDA.
Xyrem, a prescription product produced by Orphan Pharmaceuticals, had been approved
to treat excessive daytime sleepiness in patients with narcolepsy. Evidence of this off-
label promotion was obtained when a government cooperator posing as a physician
interested in Xyrem recorded his conversations with Caronia and one of the physicians
hired by Orphan (Dr. Peter Gleason) as a promotional speaker. During these recorded
conversations, Caronia and Gleason promoted Xyrem for unapproved or off-label
indications such as fibromyalgia, muscle disorders, chronic pain, fatigue and for use in
unapproved patient populations. The Courts subsequently charged Caronia with and
42
convicted him of participating in an unlawful conspiracy to introduce Xyrem for
unapproved uses into interstate commerce. From the point of view of the FDA, Xyrem
was "misbranded" within the meaning of the FD&C Act. However, the government never
asserted that Caronia’s statements about the drug were false or misleading. Rather, the
government’s claims were based entirely on the theory that Caronia had promoted (or
participated in promoting) Xyrem for unapproved uses and/or patient population ("US v.
Caronia," 2012).
The Second Circuit U.S. Court of Appeals reversed the conviction in December 2012,
ruling that truthful and non-misleading communications between a pharmaceutical
company representative and a licensed physician constitute protected speech under the
First Amendment and cannot serve as the basis for criminal conviction. The Appeals
court agreed with Caronia that truthful and non-misleading off-label promotional speech
is constitutionally protected under the First Amendment. It cited as precedent to a 2011
Supreme Court decision, Sorrell vs. IMS Health, a case in which a Vermont law
restricting pharmaceutical companies from using prescription data for marketing
purposes was overturned on freedom of speech grounds. The Second Circuit noted that
while the FD&C Act does not specifically prohibit off-label promotion, the FDA has
taken the position that off-label promotion constitutes misbranding. It quoted FDA's
position that “[a]n approved drug that is marketed for an unapproved use (whether in
labeling or not) is misbranded because the labeling of such drug does not include
'adequate directions for use”. It further expressed concern that the government has
43
repeatedly (and successfully) prosecuted pharmaceutical companies for misbranding
based on off-label promotion (McGill, 2013).
It remains to be seen whether the jurisdiction and authority of the FDA in off-label, but
truthful promotion will be further clarified at the level of the Supreme Court. It is further
not yet clear what effect any new judgement will have on the ability of the FDA to
restrict free commercial speech in a wide variety of areas beyond even the
communications between a single salesperson and a single doctor. The potential
implications for promotion using social media remain particularly important, as discussed
in more detail below.
2.2 Social Media as a Disruptive Technology for Product Promotion
The extraordinary uptake of social media for many kinds of interactions has been
considered as one of the most fascinating cultural changes of the 21st century and one
that promises to revise the landscape of medical product promotion. Traditionally, mass
media channels were characterized by certain features:
a) “one-to-many” communication: a message from a single source is
directed at a large audience;
b) anonymous receivers: recipients of the message typically know who
authors the message, but the author does not know the identities of all of
the recipients;
c) one-way communication: recipients cannot respond directly or
interactively to the received messages; and
d) clear distinction between authors and recipients: the producers of nearly
all content are commercial companies, nonprofit media organizations, and
governments. Ordinary people can only participate as audience members.

44
Let us consider traditional promotional methods. One-way communication such as
reading a book, listening to a CD or watching television, does not enable direct
interaction or feedback with the distributor, producer or author from receivers of the
messages. Receivers will need another form of media for such an interaction. The
advent of the internet has redefined the parameters traditionally associated with all mass
media (Croteau, Hoynes, & Milan, 2011). However, the introduction of computers
marked a new age that broke all of the customary rules. Academics and computer
scientists first pioneered the use of electronic “bulletin board" systems that allowed
members to post short messages about specific areas of interest on a central computer.
Usenet, developed in the 1970s, was the first such distributed system, which ran on
university and research networks and later developed into a broader discussion systems.
Later, the use of file transfer protocols (FTP) made it possible to share large files. Now,
the internet has become a highly adaptable communications platform on which digital
media content can be delivered to a wide variety of devices, including desktop
computers, wireless laptops, smartphones, and other mobile devices (Cohen-Almagor,
2011).
The growth of digital media and the rise of the internet and mobile devices have
combined to change the nature of mass media in several ways (Lister, Dovey, Giddings,
Grant, & Kelly, 2008). First, the internet provided an unprecedented opportunity for
social interactions and two-way communications. The rapid development of internet
technologies in the 1990s brought data networks into broader use. Initially, these took
the form of newsgroups between users. Millions of consumers gained access to e-mail
45
accounts through services such as America Online and Compuserve. The initial
interactions were not fluid, and most content relating to products was generated and
posted on company websites, again in a pattern more like that of traditional mass media
with little capability for client feedback. In this early environment, FDA was able to
apply its already existing regulations to internet promotion of therapeutic products
because Web-based advertising differed little in its content and level of interactivity from
traditional media-based advertising.
As the internet gained greater usage across society, however, internet technology became
remarkably enhanced in a way that enabled users to customize, create, and share content.
Web 2.0, one of the popular labels given to denote this collection of interactive
capacities, extended the original internet and changed this environment enormously.
Web 2.0 represents a paradigm shift that facilitates and encourages users to disseminate
content to the internet, thus placing the user as a producer, as well as a consumer, of
online content. Today, the internet has become a forum where by individual consumers,
rather than companies generate content more often; and where interactivity remains a key
feature that is valued and exploited by its users. Thus, the newly empowered users are
not traditionally recognized healthcare experts, but members of the public, who
communicate through blogs and social networking sites (Hughes, Joshi, & Wareham,
2008b; Sarasohn-Kahn, 2008).
Social networking sites are a source of many-to-many communication, but they can also
act as a vehicle for mutual one-to-one communication between a provider and a social
46
receiver in social interaction. This gives the social media channel the potential to be a
rising force that allows health information to be disseminated by combining the benefits
of interpersonal communication (e.g., personal contact) with the benefits of mass media
(e.g., broad reach and interaction) (Croteau et al., 2011).
It can be difficult to predict how new media technologies will evolve and how they will
be exploited as a result of the range of options and its interaction with human behavior
(Douglas, 1989). The development and application of the internet and related media
technologies are shaped by factors such as the legal regulations, social norms, and market
pressures, as well as the inherent technical properties of that medium (Lessig, 1999). To
understand the relationship between media and society, the most important question is
not, “What does a new technology do to people?” but, instead, “How do people use the
new technology ? ” (Croteau et al., 2011).
Historically, the revenue streams of media companies were provided by traditional media
either by selling content to audiences (e.g., books, movies), or by selling audiences to
advertisers (e.g., radio and television commercials). Often, a promotional strategy would
involve a combination of the two, as is done by some newspapers and magazines. Social
media technology, however, has changed these traditional revenue models. New media
technologies have made it difficult for companies to sell content to users. Digitization
made it simple to copy internet content, and internet connectivity made it easy to share
that copied content. Users of the internet quickly developed a culture of free or low-cost
sharing that has challenged companies who try to charge for content. Newspapers
47
previously hoped that users would pay to access their content on a website, but this
seldom happened. In fact, when they tried to charge their audiences, many users simply
went elsewhere to find similar information from other free sources (Stephen & Galak,
2010).
The new ability to find free information also drove changes in the healthcare sector.
Social media began to surpass television and print media as the primary source of health-
related information. The numbers of consumers who have researched prescription drug
information online (ePharma) in the past 12 months for themselves or others continues to
grow, driven in part by the increase in the number of older consumers using the internet
in recent years. In 2010, approximately 112 million or 48% of U.S. adults were ePharma
consumers or individuals online for pharmaceutical information – up from 55 million
consumers in 2005 (Ressi, 2011)(Figure 1).
48
Figure 1: Use of the internet for health continues to rise. Modified from (Ressi, 2011)

In addition, a recent survey conducted by Health Research Institute (HRI) attested to that
fact that, in their estimation, 42% of consumers have used social media to access health-
related consumer reviews. Thirty-two percent of respondents have used social media to
assess family/friend health experiences, and 29% have sought information related to the
experience of other patients with their disease (Barnes et al., 2012).
49
Figure 2: Percentage of consumers viewing health information through social media.
Modified from (Barnes et al., 2012)

Social media encompasses a wide range of uses. Primary uses include advertising and
promotion, public relations (PR) and customer services. However, a large number of
emerging uses can be identified to include market research, sales, and product
development (Figure 3).
Companies derive significant marketing value from social media. Though the generation
of sales and leads is rated lower than other benefits, approximately 50% of respondents
see even this avenue as a benefit of social media (Vollmer & Premo, 2011).
50
Figure 3: Use of social media platforms. Modified from (Vollmer & Premo, 2011)

At least three key factors are central to the growing importance of the internet as a
promotional tool. These factors include 1) its pervasive use, 2) its interactive nature, and
c) its respectability in the eyes of the consumer.
2.2.1 Pervasiveness
The escalating pace with which new users have been attracted to use social networking
sites has been unprecedented. According to the Pew Internet and American Life Project,
in 2011, two-thirds of adult internet users (65%) reported using a social networking site
such as Myspace, Facebook or LinkedIn. This identified a 61% increase in usage level
compared to 2010, and, strikingly, more than doubles the percentage reporting such use
in 2008 (29%). Such figures contrast sharply with those reported in February of 2005,
51
when just eight percent of internet users, equating roughly to 5% of all adults, said that
they used such sites (Zickuhr & Madden, 2012) (Figure 4).
Figure 4: Social networking site (SNS) use by online adults, 2005-2011. Modified from
(Zickuhr & Madden, 2012)

Social networking is notable not only for its high prevalence of use but also for its
frequency of use, especially by younger users. In any typical day in 2010, 61% of young
adults online in the US used social media sites. Use was somewhat more modest amongst
older adults. About 39% of those aged 30-49 typically used the sites on an average day,
but this figure was seen also to grow, from 39% to 46%, over a single year from 2010 to
2011. Those in the age group between 50-64 lagged in their SNS use, however, the
proportion using SNS on a typical day seemed to trend more rapidly upward that that of
other users, from 20% to 32%, over that same period. It was only amongst those aged 65
52
and older that the frequency of use (13 to 15% ) did not increase significantly over 2010
(Zickuhr & Madden, 2012) (Figure 5).
Figure 5: SNS use on a typical day by age group, 2005-2011. Modified from (Zickuhr &
Madden, 2012)

Social networks come in a variety of forms. Online communities such as Facebook,
microblogs (e.g, Twitter), Pinterest, Wikipedia and video sharing (e.g., YouTube),
continue to gain widespread popularity, but they represent a small part of the much larger
social media community. Other tools include resources such as blogs, collaborative
projects, enterprise social media; location based apps, product/service rating sites, virtual
worlds, widgets and advanced user tools. Companies have used all these channels to
communicate about their products. In the healthcare sector, for example, they have
sponsored and created disease and product-focused Facebook and Twitter accounts that
can allow patients to connect to each other and exchange product and health information
53
(Sarasohn-Kahn, 2008). These channels may require sign-up but no usage fees. Such
opportunities have many potential advantages over traditional print ads or other forms of
product promotion. They attract a huge number and wide variety of users with whom it is
possible to share information in a rapid, simple and collaborative way. Bloggers and
social tribe leaders are becoming key opinion leaders, and as independent reviewers, they
can create their own communities and can drive healthcare dialogue in favor or against
particular product brands.
2.2.2 Interactivity
The way that social media operates is inherently different from the way that other media
channels have operated historically. A simple arena for distributing content and reading
static information has quickly developed into a dynamic forum where individuals can
express opinions and interact with medical product manufacturers, consumers, patients,
healthcare professionals, and others. Online interactions are so rapid that they can
become viral in nature. The messages expressed or divulged in these forums can reach an
unintended audience and thus contribute to corporate espionage, discovery in lawsuits,
assessments of regulatory compliance and human error.
In the health industry, social media allows the medical community to access and
exchange health information, product reviews, and promotional activities much faster,
more easily and broadly than ever before. Through such exchanges, social media can be
powerful in influencing health decisions and consumer choices regarding the use and
purchase of medical services and products (Divol, Edelman, & Sarrazin, 2012). The
54
power of social media has long been recognized but not fully leveraged by industry as an
engagement tool. Key social media interactions include physician-to-physician, patient-
patient, physician-patient, physician-industry or patient and physician links that foster
personal interactions and the public (Figure 6). A literature review by Cline & Haynes
(Cline & Haynes, 2001) identified widespread access to health information, the
interactivity of the medium that promotes tailoring of information and interpersonal
interaction and the potential for privacy violations as some of the benefits and risks of
online health information. However, the linkage with industry in this web of network
interaction continues to be a challenge due to potential regulatory implications (Chretien
& Kind, 2013) (Figure 6).
Figure 6: Key social media interactions among patients, physicians, and the public.
Modified from (Chretien & Kind, 2013)

Solid line circles denote secure interactions. Dotted line circles denote personal
networking interactions (Chretien & Kind, 2013).

55

2.2.3 Trust
Research also suggests that consumers are willing to trust the information that is
available on the internet and to contribute to this sharing. Sixty-one percent of consumer
respondents are likely to trust information posted by providers, 41% are likely to share
with providers via social media (compared to 37% trusting information posted by a drug
company) and 28% are likely to share information with a drug company (Barnes et al.,
2012) (Figure 7).
Figure 7: Likelihood to trust or share information via social media. (Barnes et al., 2012)

Consumer health-related searches are commonly driven by medical events, with users
looking for a "truth-risk value proposition," and "personal experience”. Two-thirds of
56
consumers reported that online information has improved the physician-patient dialogue
(Walsh, 2012). However, the way that the internet is used is related to the age of the
user, so these patterns may evolve over time. More than 80% of individuals ages 18–24
would be likely to share health information through social media, while nearly 90% of
individuals would engage in health activities or trust information found via social media
(Barnes et al., 2012).
2.3 Challenges Presented by Social Media for Medical Product Promotion
The opportunity to use social media for promotional purposes should seem desirable for
industry to understand and interact with their customers. However, effective use of the
system will depend on characterizing the seller-buyer relationships and this has become
more complex as the healthcare systems themselves have become more complex.
Historically, “marketing” was often synonymous with “selling product”. For example, in
a seminal article, “Marketing Myopia” written in 1960, Theodore Levitt criticized
marketing by stating that its practices focused primarily on selling products and to a
much lower extent on meeting customer needs. This, Levitt argued, led to strategies that
were not aligned with respect to the expectations of the marketplace. More recently, a
shift has occurred in which the customer focus has become much more central. In fact, a
few years ago, Smith & Drumwright (2010) argued that the observations of Levitt may
have been heeded too well, and that it may have produced a “new marketing myopia”
characterized by three related phenomena: (1) a single-minded focus on the customer to
the exclusion of other stakeholders, (2) an overly narrow definition of the customer and
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his or her needs, and (3) a failure to recognize the changed societal context of business
that necessitates addressing multiple stakeholders (Smith, Drumwright, & Gentile, 2010).
Opportunities exist to use social media as a lever to engage a wider range of stakeholders
beyond the traditional focus on the patient. Fred Petito, Senior VP, Managing Director,
Ogilvy CommonHealth Interactive Marketing, argues that pharmaceutical brands can
become more aligned to the needs of important constituencies, and be more responsive
and accountable to diverse members of the healthcare delivery system in addition to the
focus on customers (Petito, 2013). Further, social media provides the opportunity to use
interactive methods to profile more completely the market needs of the different
stakeholders.
Why then have companies been so cautious in their use of the social media? Many risks
counterbalance the strengths of social media to link different stakeholders so easily and
so interactively. Perhaps the most important change is that the company is no longer the
exclusive agent for the information, yet it is the only one that is substantially regulated.
Companies are restricted in what they can say about a product, but consumers, patients,
and health professionals are not bound by the same restrictions. These individuals and
groups can express opinions, advocate unusual product uses and suggest unconventional
therapies. Some of these opinions and positions may not be accurate or trustworthy, but
manufacturers cannot control this information and its effects as they could with “Web
1.0”, in which users were primarily positioned as readers (Hughes, Joshi, & Wareham,
2008a; Sarasohn-Kahn, 2008). The new environment encourages the users themselves to
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generate content that can be rapidly disseminated to many different types of users. This
shift takes the control of product-related information away from the product
manufacturers and puts it in the hands of the users, who remain immune to complying
with advertising and promotion regulations, guidance, and policies. Whether individuals
whose health or even life depends on making good healthcare decisions can properly
filter collective wisdom of non-experts is questionable. Nonetheless, any effort to create
a controlled environment, where opinions or positions could be reviewed/edited/approved
before posting, may not be embraced by users who expect instant and unedited
communication. The internet and social media networking sites are often viewed by users
as a progressive space where the “collective wisdom can and should be harnessed”
(Eysenbach, 2008). The idea of harnessing the power of collective knowledge was
popularized in Surowiecki’s book “the wisdom of crowds,” in which he argues that large
groups of people are often smarter than the smartest members. He further argues that,
“even if most of the people within the group are not especially well-informed or rational,
it can still reach a collectively wise decision” (Surowiecki, 2005). However, it is
debatable whether this utopian view can hold when often-untutored individuals discuss
issues on which they have only limited information. No mechanism exists to limit the
speech of many individual content generators and to identify the source of that content or
the extent to which it has been disseminated. This can put companies in a difficult
position, because regulatory requirements limit the ability of industry to disseminate
information about off-label use or respond to users who advance extreme or even unsafe
practices.
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2.4 Views of Stakeholders with regard to Social Media
A primary goal of the research here is to understand some of the forces shaping policy
development. Good policy development depends on understanding the often divergent
views of stakeholders. Freeman defined stakeholders as “any group of individuals who is
affected by or can be affected by the achievement of an organization’s objectives”
(Freeman, 2010). Traditionally, when corporate or business policies are considered,
stakeholders have been categorized into two groups: 1) a main group that includes the
primary customers of the organization, including its shareholders, employees,
consumers, and affiliates; and 2) a secondary group that includes regulators,
policymakers, government, general public, competitors, future generations and anyone
else who may be affected by the actions and decisions of the corporation (Fontaine,
Haarman, & Schmid, 2006).
When dealing with policies related to medical product industries, it is not easy to deal
with stakeholders as if they were easily divisible into two groups. Multiple stakeholders
can be identified and this variety of stakeholders can increase the potential for conflicting
expectations to arise (Gregory & Keeney, 1994). As a result, some researchers suggest
classifying stakeholders according to 1) the stakeholders’ power to influence the firm
(i.e., organization), 2) the legitimacy of the stakeholder’s relationship with the firm
(organization), and 3) the urgency of the stakeholder’s claim on the firm (organization) to
help address the problem of competing interests (Mitchell, Agle, & Wood, 1997). These
different approaches are more easily understood once the views of stakeholders are
60
captured. Much has been written about the views of some stakeholder groups that are
affected by FDA’s policies with regard to social media, but other stakeholders are less
vocal and more difficult to understand.
An additional complication that must be acknowledged in the analysis of stakeholders in
the medical product field is the fact that the same individual can take on different roles at
different times. A participant in a social networking site can be a patient on one day, and
a self-professed authority or an advocate for a product on another. Shareholders,
managers, and employees of a medical product company may also be consumers of the
same or similar product. Physicians and pharmacists that make up advisory boards for the
FDA can also serve on scientific advisory boards of companies in addition to undertaking
the role of healthcare provider for patients, thereby creating a potential conflict of interest
(Angell, 2009; Cauchon, 2000). The regulators and advocacy groups may also be
physicians and/or consumers. The diversity and blurred lines between different
stakeholder groups must be borne in mind when identifying stakeholder groups.
Despite the complexity, four principal stakeholders can be identified for the purposes of
this research:
1) the patients or consumers who are seeking information about products
to assist the diagnosis or treatment of a disease,
2) the healthcare professionals who prescribe or recommend medical
products,
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3) the regulators who are charged with assuring that the interactions
between the patients and providers result in safe and efficacious
outcomes, and
4) the industry that supplies information about products that they make
and sell.
These groups have different views and concerns about the use of social media for medical
product promotion.
2.4.1 The Patient
Traditionally, consumers appear to be in favor of access to information by way of
pharmaceutical advertising directed at them. A 1999 survey by Prevention Magazine
found that 76% of surveyed consumers felt that DTC advertisements allowed them to
become more involved in the management of their health care (J. E. Calfee, 2002). A
second survey in 2002 suggested that 61.1 million Americans since 1997 were prompted
by a DTC advertisement to talk to their doctor about a medical condition they previously
had not discussed (Liu & Doucette, 2008). However, not all evidence suggests that
consumers are so enthusiastic of DTC advertising. For example, a recent report in 2002
has shown that only 32% of polled respondents indicated that they “like seeing” DTC
advertisements when compared to results of 52% in 1999 (Vogt, 2005).
Social media is a new way for DTC communication, and some have questioned whether
it will replace conventional media advertisements for patients. Looking more broadly at
the online landscape, 72% of internet users say they searched online for health
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information of one kind or another in 2012 (Fox & Duggan, 2013); information about
risks was the predominant information sought (Aikin, Swasy, & Braman, 2004). At the
same time, it seems clear that the way consumers are acquiring information is not well
controlled. For example, Yang and colleagues (Yang, Seo, Patel, & Sansgiry, 2012)
found that FDA-unregulated advertisement videos for prescription drugs had a higher
number of views than FDA-regulated advertisement videos. Research suggests,
however, that the internet supplements, rather than substitutes for, health information
from other sources, and particularly that from the health professional (Ybarra & Suman,
2008). Healthcare professionals remain the number one source of health information for
American adults, with 86% of American adults seeking the advice of a healthcare
professional when they need medical information or assistance (Fox & Jones, 2010).
Further, Baker and colleagues found that online healthcare information had very little
impact on how often internet users contacted their healthcare provider. In their study,
more than 90% of survey respondents said that the internet had no effect on how
frequently they made such contacts (Baker, Wagner, Singer, & Bundorf, 2003).
2.4.2 Advocacy Groups
Advocacy groups might be considered as a special class of “consumer”. Advocacy
groups are groups that often represent and crystallize the opinions of certain subsets of
consumers. They can provide insight into the views of some consumers, although these
views often do not represent the full range of consumer opinion. Advocacy groups may
receive their financial support from individuals or groups with vested interests in certain
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policy decisions. Thus, information from such groups must be used cautiously as an
index of the views of a larger group of stakeholders. Nevertheless, they can be often
sources of information about hot-button issues (Hays & Urofsky, 2001).
In general, advocacy groups can be cautious about risk and can espouse options that are
designed to increase consumer protections. One example is the Prescription Project that
submitted a Citizen Petition to the FDA in December 3, 2008, requesting that the FDA:
(a) send a letter to all “major” prescription drug and restricted medical
device manufacturers stating that the internet advertising and promotion
is subject to the same requirements as advertising in traditional media;
and (b) issue a Draft Guidance on Consumer-Directed Broadcast
Advertising of Prescription Drugs and Restricted Devices on the internet,
which would; (1) clarify that online promotions meet the definition of
“broadcast advertisements” in 21 C.F.R §§202.1(e)(1) and (I)(1); and (2)
describe the requirements for online advertisements under section 502 of
the FDCA.

The Prescription Project argued that the statutory and regulatory framework for broadcast
advertising is sufficiently broad to govern promotional material online (21 C.F.R. 202.1),
but suggested that its enforcement may be challenging. The Prescription Project argued
that the manufacturers evade statutory and regulatory requirements by hiring third parties,
such as marketing firms, to place video content on YouTube and other interactive media.
The FDA has yet to respond to the Citizen Petition (Barlas, 2010).
A similar set of viewpoints was captured in November 23, 2010, in a complaint filed by
four advocacy groups (Center for Digital Democracy, U.S. PIRG, Consumer Watchdog
and World Privacy Forum) with the FTC against several large online health care
companies – Google, Microsoft, QualityHealth, WebMD, Yahoo, AOL, HealthCentral,
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Healthline, and Everyday Health. The complaint titled “Online Health and
Pharmaceutical Marketing that Threatens Consumer Privacy and Engages in Unfair and
Deceptive Practices” presents a negative picture of marketing practices conducted by
many health care and advertising companies in the online environment. Broadly, the
complaint is concerned that the use of personal data to access consumers through online
advertising (e.g., behavioral targeting) is unfair and deceptive. They argued that:
Digital marketing raises many distinct consumer protection and privacy
issues, including an overall lack of transparency, accountability and
personal control, which consumers should have over data collection and
the various interactive applications used to track, target, and influence
them on line (including on mobile devices). The use of these technologies
by pharmaceutical, health product, and medical information providers
that directly affect public health and welfare of consumers requires
immediate action.

They mentioned other practices including the use of unbranded websites to promote
connections to brands that are sponsored by drug manufacturers. The groups asked the
FTC to work with the FDA and other agencies to develop a set of policies that would
regulate the use of behavioral targeting, data collection and other digital techniques in the
marketing of drugs and health-related products (Lenzer, 2011).
2.4.3 The Health Care Professional
Social media gives healthcare professionals a number of opportunities to communicate
with peers and patients. Physicians form peer-to-peer closed networks to share
experiences and questions relating to clinical cases or issues related to practice
management. For example, a recent survey of oncologists and primary care physicians
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found that 61% of physicians claim to search for medical information and 46% contribute
new information on the web at least weekly. However, reasons for use varied between
the two targeted groups. Oncologists reported that they were more likely to use social
media to identify innovations, whereas primary care physicians were more likely to use it
to interact with and learn from peers. More than 57% of respondents identified that
social media was beneficial, engaging and provided an avenue for current, high quality
information, and 60% believed that social media improved the quality of patient care that
they delivered (McGowan et al., 2012).
Physicians also use social media to reach patients. Trade journals such as Fierce Practice
Management have reports from physicians that describe how they have been able to
increase the number of patients in their practices by sharing information with patients by
social media, whether to correct misconceptions or to attract patients to their practice.
For example, interviews conducted by Beaulieu in 2011, identified that many physicians
reach their new patient base by interacting with potential clients by Twitter, YouTube and
Facebook. The growing use of social media by both patients and physicians is often
considered to be a cost-effective way to initiate and maintain connections with a large
number of key stakeholders (Beaulieu, 2011).
Physicians also have opinions about the information presented by others through social
media. Several studies have been conducted to understand how physicians’ feel about
DTC advertising from medical product companies. These studies initially explored the
views of physicians with regard to DTC advertising appearing in media sources in
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general. Perhaps the most quoted study was that in 2003, which appeared in the form of
a talk paper released by the FDA. In this survey of 500 physicians, views were about
evenly distributed between those who felt that the DTC advertising had positive impact
on their patient care, those that saw the effect as negative and those that did not see any
effect at all. Many physicians were of two minds about the benefits and negative aspects
of such advertising. On one hand, such ads were viewed as responsible for prompting
improved interactions and discussions with patients who might otherwise be silent on
symptoms or health concerns. On the other hand, they found that patients sometimes
asked for unnecessary medications that were advertised in the media (Aikin et al., 2004).
However, a number of other studies of physician views have yielded varied results, with
views that DTC advertising were not “a good idea” as high as 80% (Lipsky & Taylor,
1997; Weissman et al., 2004). Physicians have also identified other potential drawbacks
that they associate with DTC advertising. They often expressed the view that the quality
of the information impacted the physician-patient relationship (Murray et al., 2003), that
DTC advertisements do not present benefits and risks in a balanced manner, and that such
advertising may ultimately cause physicians to write more prescriptions (Mintzes et al.,
2003). At the same time, others have disagreed with these findings. For example, a
study conducted by Donohue and Berndt (Donohue & Berndt, 2004) gave conflicting
evidence, suggesting that DTC has little impact on drug choice in antidepressant studies.
Whether DTC advertisement is becoming less effective is of considerable interest. A
literature review of published data conducted in 2011 by Prevention Magazine’s 14th
Annual Pharmaceutical Direct-to-Consumer Advertising Study provided evidence that
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the proportion of patients who talked with a doctor regarding a specific medicine that
they saw or heard advertised was trending below the long running average of 33%
between 1997 and 2011 (Carlson, 2011) (Figure 8).
Figure 8: Average number of consumers who talked with a physician about specific
medicine that was advertised. Modified from (Carlson, 2011)

More recent discussions amongst healthcare professionals regarding DTC promotion
through social media have begun to appear. In 2007, Friedman and Gould identified that
the internet is increasingly used by physicians and that this medium may assist in
supporting better communication with patients regarding drug information including its
risks and benefits (Friedman & Gould, 2007). To date, no systematic study of physician
views with respect to DTC advertising appears to have been carried out. It is likely that
the same issues, both positive and negative, that healthcare professionals have identified
with DTC advertising through traditional media sources, will also be identified for
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internet advertising, but the relative proportions of largely satisfied or dissatisfied
individuals will need to be explored.
Given so little is yet known about the evolution of attitudes by healthcare professionals
since the flurry of studies prior to 2004, FDA has expressed its intent to execute another
study for an updated sense of physician attitudes as a follow up to the study in 2002
described above.
Specifically, FDA will: 1) recruit a wider range of prescribers, including
nurse practitioners and physician assistants, 2) weight the data to obtain a
sample of healthcare professionals, and 3) ask a wider range of questions,
both about DTC and professional promotion of prescription drugs (FDA,
2014f)

Presumably, this FDA survey will ask specific questions on internet advertising, which is
a major issue of concern to the regulators.
2.4.4 The Regulators
An important role given to the FDA and FTC is the responsibility to assure the
dissemination of accurate and truthful information regarding medical products to health
care providers and the public. Each of these regulatory bodies, however, plays a different
role. The FDA governs the labeling of all medical products and the advertising of
prescribed medical devices and drugs, whereas FTC oversees the advertising of OTC
products.
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2.4.5 The Food and Drug Administration
FDA’s perspective with respect to the promotional use of social media can be gathered
from their remarks in public statements, conferences, briefing documents and warning
letters. The FDA appears to recognize the need to understand more fully how the internet
can be used to communicate accurate, science-based and timely information to consumers
and healthcare professionals (FDA, 2009e). One issue that arose early was whether
product promotion over the internet should be treated as advertising or labeling. In a
Federal Register announcement about a public hearing on the regulation of DTC
Advertisements of prescription drugs, the FDA requested comments on the types of
disclosure that should be required for promotions made by new computer-based vehicles
such as the internet (FDA, 2005). The FDA questioned whether promotions via the
internet are a form of print (labeling) or broadcast (advertising) media. Nevertheless, as
described earlier, the position of the FDA until very recently was that information on the
internet could be handled in ways that were essentially the same as those used
traditionally for other forms of media advertising.
Currently, however, the views of the FDA seem to be undergoing revision. The FDA
released three draft guidance documents in 2014, on how companies can use social media
platforms, such as Facebook and Twitter, in product communications and promotions
social media.
This may have been driven by the provision in the Food and Drug Administration Safety
and Innovation Act passed in 2012 (Congress, 2012). It directed the FDA to develop
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rules related to social media by July 9, 2014. Three potential outcomes from this process
are anticipated: (1) that the FDA would finalize the draft guidance documents to capture
the Agency’s rationale on everything from online video promotion to how to present risk
information into a tweet, (2) that the Agency would be brought before Congress for
interrogation, and (3) the FDA would roll out incremental changes in regulation over the
next few months or years to fold new communication methods into existing documents,
integrating rather than isolating social media.
The manner in which FDA has dealt with DTC promotion is evident in the contents of
FDA warning letters issued to the industry. A survey of warning letters and untitled
letters from the late 1990s and early 2000s suggests that FDA considers the Web as other
promotional outlets. Initial evidence regarding enforcement in the social media
marketing arena came in April 2008, when DDMAC issued a warning letter about a
streaming DTC video for Viagra that appeared as an advertisement on CNN.com. In this
action, DDMAC applied standards similar to the ones applicable for television
advertisements. The FDA alleged that Pfizer discussed the benefits of using Viagra in
the online advertisement without disclosing any risk information. In the video, part of
Pfizer’s Viva Viagra campaign, a member of a bluegrass band touted Viagra’s benefits
before telling viewers to “Talk to your doctor about Viagra”. The DDMAC found this
advertisement to contain “serious” violations of FDA regulations. In a relatively rare
move, Tom Abrams, director of DDMAC, signed the letter himself (FDA, 2008a). The
letter to Pfizer was only the first of many to be sent. On September 25, 2008, Johnson &
Johnson and Novartis received warning letters regarding webpages for the drugs,
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Concerta and Focalin (FDA, 2008b, 2008c). Similar warning letters were also issued to
the industry in response to alleged overstatements of benefits, broadened indications,
omission or understatements of risk information and other implied claims on the internet
(Reeves, Lee, Markus, Tseng, & Chan, 2011).
On April 2, 2009, DDMAC issued 14 untitled letters to companies for violations related
to sponsored links on search engines by pharmaceutical companies (FDA, 2009a). It
challenged the use of “sponsored links”, a mechanism used to search for product
information or disease conditions based on certain key words on the internet. FDA
alleged that the links made product claims without providing the required risk
information. The Agency further explained that providing the link to the product’s Web
site, where information about the drug’s risks and benefits was outlined in more detail,
“does not mitigate the misleading omission of the information” (Brady, Manning,
parsons, & Smith, 2009). Additionally, the letter stated that the sponsored links failed to
adequately communicate the drug’s indication, or broadened the indication, by failing to
disclose limitations to the indication for the drug, such as the appropriate patient
population, disease stage, or use as a combination therapy. Finally, the sponsored links
failed to use the required established names verses the brand names.
Until the April 2008 warning letters, the medical products industry had followed its own
“one-click rule”, by which a manufacturer would provide labeling and risk information to
consumers, as long as pharmaceutical companies provided risk information within one
click of their search ads — on the page to which the ad linked— they assumed they were
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in compliance (Clifford, 2009). The warning letters prompted drug makers to decrease
sharply their use of sponsored links (Arnold, 2009). This change in approach gave
significant advantages to foreign drug suppliers and companies marketing homeopathic
remedies, who were less concerned about FDA enforcement, and who increased their
market presence online (IAB, 2009). In 2010, the number of notice of violation and
warning letters issued by DDMAC increased to 52 (Senak, 2011). Of the 52, thirteen
were website-related. The bulk of these violations were related to non-digital media, but
one involved social media.
Tom Abrams, head of DDMAC at FDA, commented at the Drug Information Association
meeting in 2009, that FDA had received an increasing number of complaints from
physicians over the promotion of prescription drugs (FDA, 2009b). These complaints
came simultaneously as some medical institutions and private physician offices began to
prohibit sales representatives from coming onto their properties to detail their physicians,
but it is not clear whether the internet advertising was seen as a new channel to reach
physicians. He stated that: “a common thread is that we need to have responsible
promotion that is accurate, non-misleading and balanced with the appropriate risk
information that will advance the public health and help improve the image of industry
and FDA”. Abrams stated that continued public and congressional pressure on FDA’s
performance in medical product safety means that safety information presented in
promotional pieces and promotional claims of a drug company will remain a primary
focus of DDMAC.

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In the face of the enforcement actions, many stakeholders have questioned the failure of
FDA to provide timely guidance around the use of internet media (Senak, 2009). In
August 2009, FDA formally entered into this debate when it published an announcement
seeking comments on certain key questions related to the internet and social media to
assist their development of specific guidance documents (74F.R.48083). The FDA
subsequently held a Part 15 Hearing on November 12-13, 2009, on the same topic. More
than 800 people requested a seat at the hearing, overwhelming the capacity of the
auditorium, which held approximately 350, and requiring a webcast by which the
overflow could view the hearing remotely. A wide representation from not only industry,
but also marketing, communications, legal, consulting and other online businesses were
present. Over 70 including representatives from JNJ, Pfizer, Lilly, AdvaMed, PhRMA,
WebMD, Google, and Yahoo were among the speakers (FDA, 2009d).
The FDA asked presenters to respond to five questions specific to online drug promotion:
(a) accountability: For what online communications are manufacturers
(including packers and distributors) accountable?
(b) satisfying regulatory issues: How can manufacturers fulfill regulatory
requirements of fair balance (risk/benefit) in their internet (IN) and social
media (SM) promotion, particularly when using tools that are associated
with space limitations and tools that allow for real-time communications
(e.g., microblogs, mobile technology)?
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(c) posting corrective information: What parameters should apply to the
posting of corrective information on web sites controlled by third parties?
(d) linking: When is the use of links appropriate?
(e) adverse event reporting: How are entities with post-marketing
reporting responsibilities and other stakeholders using the internet and
social media tools with regard to monitoring adverse event information
about their products?
Even though the discussions with FDA have proceeded for several years, no final
guidance has yet been provided. In June 2009, Kristen Davis, deputy director of
DDMAC, cited lack of resources as one of the reasons for the delay. Specifically, she
stated:
We have limited resources-the fact that you didn’t hear from us, just like
the fact that you went 15 miles over the speed limit on your way to work-
doesn’t mean it’s ok. It just means the cops weren’t on the road that day.
Unless you have advisory comments indicating our opinion, you are not
insulated from enforcement action.

She also maintained that FDA had clear guidance regarding what advertisers had to
disclose in advertising (PharmExecBlog, 2009).
Another reason for the delay may relate to the nature of the existing regulatory system
which often contains conflicting elements, in which hard rules must exist while
maintaining transparency and access during the development process (Wilson, 2000).
Policy development has multiple stages at which requests are made for inputs from key
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stakeholders including: industry, trade associations, advocacy groups, regulators, experts
and consumers. Responses to stakeholder comments can slow the process substantially.
Other factors, including the need to consider previously unanticipated concerns from
these stakeholders, may surface during this process of developing guidance. The
feedback can drive changes to the content or even abandonment of proposed guidance,
thereby complicating and lengthening the process.
2.4.6 Draft Guidances on the use of Social Media
Since its first efforts to provide guidance in 2009, the FDA has issued a number of
guidance documents related to promotional practices using social media. Each addresses
narrowly defined topics. Descriptions of the guidance documents are included below.
2.4.6.1 Fulfilling Regulatory Requirements for Postmarketing Submissions of
Interactive Promotional Media for Prescription Human and Animal Drugs and
Biologics
The first document in the series issued in January 2014, describes FDA’s current thinking
on what the Agency considers to be interactive promotional media and outlines the
considerations in determining if product communications using interactive technologies
are subject to FDA postmarketing submission requirements. Furthermore, the draft
guidance provided FDA’s recommendations for how firms can fulfill the regulatory
requirement to submit postmarketing promotional materials to the FDA in a practical
manner to address the potential volume of real-time information that is continuously
posted and shared through various interactive promotional media platforms. The
recommendations in this draft guidance also apply to biological products approved for
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marketing under section 351 of the Public Health Service Act (PHS Act). Given each
biological product also meets the definition of “drug” or “device” under the FD&C Act, it
is also subject to provisions of the FD&C Act applicable to drugs or devices, as well as
the regulations implementing these provisions. However, a biological product licensed
under section 351 of the PHS Act is not required to have an approved new drug
application under section 505 of the FD&C Act (21 U.S.C. 355). The recommendations
in this draft guidance do not apply to veterinary biological products regulated under the
Virus-Serum-Toxin Act (21 U.S.C. 151, et seq.) by the U.S Department of Agriculture
nor medical devices specifically. In June 2014, the FDA issued two additional pertaining
to the internet/social media for comments.
2.4.6.2 Platforms with Character Space Limitation
Character space limitations are the subject of the first guidance, Draft Guidance for
Industry on Internet/Social media Platforms with Character Space Limitations;
Presenting Risk and Benefit Information for Prescription Drugs and medical devices,
specifically presenting risk and benefit information. Examples of media platforms
subject to the guidance are online microblog messaging (e.g., twitter) and online paid
searches (e.g., sponsored links on search-engines). FDA’s policy on presenting risk and
benefit information on internet/social media platforms with character space limitations
states that a firm choosing to make a product benefit claim should also incorporate risk
information within the same character space limited communication. The firm should
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also provide a mechanism to allow direct access to a more complete discussion of the
risks associated with its product.
The FDA also stated that it is important that risk information together with benefit
information be presented within each individual character-space-limited communication
(e.g., tweet). The content of risk information presented within each individual character-
space-limited communication at a minimum should, include the most serious risk
associated with the product. However, the guidance does not address certain key features
and abilities of these channels. For example, electronic/digital platforms have the
capability of uploading product images and video clips depicting product images, features
or benefits without the use of characters into the digital platforms. The FDA guidance
also attempts to introduce other terms (‘reminder advertising”, “reminder promotion”)
which are not currently defined in 21 CFR 200.200, 201.100(f), 201.105(d)(2),
202.1(e)(2)(i) and 801.109(d) which refers to the term “reminder labeling”. It is not clear
if FDA intends to differentiate among these terms and their implications to the industry
(FDA, 2014d).
2.4.6.3 Sponsor Corrections of Misinformation
Correcting independent third-party misinformation is the subject of the third guidance,
Draft Guidance for Industry on Internet/Social media Platforms: Correcting Independent
Third-Party Misinformation about Prescription Drugs and medical devices. This
guidance applies when a firm is not responsible for a product-related communication that
appears on the firm’s own forum, an independent third-party website, or on social media,
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and the firm chooses to correct misinformation about its own product contained in that
communication. A firm may provide appropriate truthful and non-misleading
information or alternatively provide a reputable source to obtain correct information (e.g.
the firm’s Medical Affairs Department). By including the following, the information will
be deemed “appropriate corrective information:”
(a) Be relevant and responsive to the misinformation
(b) Be limited and tailored to the misinformation
(c) Be non-promotional in nature, tone, and presentation
(d) Be accurate
(e) Be consistent with FDA-required product labeling
(f) Be supported by sufficient evidence
(g) Either be posted in conjunction with the misinformation or reference the
misinformation and be intended to be posted in conjunction with the
misinformation
(h) Disclose that the person providing the corrected information is affiliated with the
firm
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(i) Include the FDA-required labeling (if accomplished via a URL, it can’t be
promotional in content or tone or link to a promotional website containing the
FDA-required labeling).
Even though FDA has recommendations for the correction of misinformation about
prescription drugs and medical devices, it does not clearly define whether the individual
affiliated with the company must reside in a specific functional area unrelated to the
commercial operations.
2.4.7 Federal Trade Commission
The Federal Trade Commission (FTC) also has a significant role in the oversight of
advertising, and particularly advertising for over-the-counter products. FTC’s views with
regard to its authority and enforcement seem quite clear, and are reflected in the actions
that it has taken historically. The test originally articulated in FTC’s 1983 Deception
Policy Statement (FTC, 1983) is one of the most cited standards. It stipulates that an act,
practice or omission is deceptive if “it is likely to mislead consumers acting reasonably
under the circumstances, in a material respect” ("Kraft, Inc. v. FTC," 1992). The
Commission has successfully challenged deceptive representations disseminated to
consumers in virtually every kind of marketing medium, including the internet (Maher &
Fair, 2010).
The FTC enforces section 5 of the FTC Act, which broadly prohibits “deceptive or unfair
acts or practices in or affecting commerce” (15 U.S.C. §45). Section 12 of the FTC Act
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more specifically prohibits the dissemination of false advertisement for foods, drugs,
non-restricted devices, services or cosmetics (15 U.S.C. §52). A three-pronged test is
used to determine whether a representation, omission, or practice is deceptive: 1) Does it
mislead or is it likely to mislead a consumer? 2) Is the consumer’s interpretation
reasonable under the circumstances? and 3) is the representation, omission, or practice
likely to affect the consumer’s conduct or decision with regard to product or service?
(FTC, 2008). All these elements must be established for a practice to be deemed
deceptive regardless of the medium in which advertisers disseminate their claims. In
addition to deceptive acts or practices, section 5 of the FTC Act also prohibits acts or
practices that create monopolies or tip the level playing field. In accordance to FTC’s
Policy Statement on Unfairness, an act or practice is unfair if 1) it causes or is likely to
cause substantial injury to consumers; 2) cannot be reasonably avoided by consumers;
and 3) is not outweighed by countervailing benefits to consumers or to competition (FTC,
1980).
The FTC legal framework differs from that of FDA in that it sees itself as primarily a law
enforcement agency. According to FTC’s Policy Statement Regarding Advertising
Substantiation (substantiation Policy Statement), advertisers must be able to substantiate
all of their objective advertising claims before disseminating them to consumers (FTC,
1986). This requirement is based on the premise that an objective claim about a product
carries with it an express or implied representation that the advertiser possesses a
“reasonable basis” for the claim. The kind of substantiation under section 5 depends on
the nature of the advertising claim. In social media, as in conventional advertising,
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companies are expected to possess appropriate substantiation for all expressed and
implied claims that reasonable consumers might take from their advertisements. In
addition, FTC has acknowledged that companies cannot control real-time
communications on a third-party site, but nevertheless should be responsible for the
discussions and posted content on sites that they sponsor. Thus companies must be wary
of sponsoring blogs if they are intended, or could reasonably be expected, to discuss
medicines/devices and their uses, because of the challenges to ensure compliance with
applicable regulations. Further, if a company pays or otherwise remunerates bloggers,
they should disclose their affiliation prominently in proximity to the blog content (FTC,
2013).
2.4.8 The Industry Perspective
For medical product companies, complying with the requirements of FDA and FTC has
never been so complex. New policies and guidance are being instituted, enforcement
actions and criminal investigations are increasing in frequency, and court cases continue
to provide case law to keep pace with the new methods of promotion as they are
introduced. At the same time, the penalties that can follow non-compliance are
significant; they include: enforcement actions, heavy fines, criminal penalties for specific
individuals and even suspensions for the offending manufacturers from doing any
business with or for federal prescription benefit plans (Vivian, 2011). The views of
industry with respect to their social media operations within this environment are perhaps
the most difficult to capture because published information is relatively scanty.
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Nevertheless, an appreciation of concerning issues can be found in documents from three
sources: materials issued by trade associations, responses of industry to FDA inquiries
and hearings, and articles in journals and the trade press.
2.4.9 Materials from trade associations
Materials published by trade associations are not usually the outcomes of systematic
research. More typically, they represent the commercially driven views of large
companies, expressed through organizations that serve as lobbying as well as trade
development arms of the members. Thus, the materials that they produce and the
positions that they take might be criticized as lacking in broad representation or balance
(Darcey, 2009). Nevertheless, the views that are expressed can be useful signposts to
identify areas that might be examined more systematically. A few such sources include:
slide presentations, letters to the FDA and trade journal articles from PhRMA, a trade
group for companies producing branded drugs, and AdvaMed, a trade group for those
producing medical devices. Typically, these have called for 1) an acceleration of work
on finalizing guidance concerning internet and social media promotion, and 2) caution
regarding expectations that companies monitor web-based social media for information
that might be published regarding adverse events relating to their products (AdvaMed,
2013). Further, PhRMA advocates that DTC can “foster competition among products,
which can lead to improve quality and lower prices for consumers” (Vogt, 2005). It
seems apparent from these sources that the industry, presented through the view of trade
associations, favors a consistent regulatory approach that assures a level playing field
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regarding rules governing promotion in social media, as in other aspects of regulation, as
has been suggested by Seiguer and Smith (Seiguer & Smith, 2005).
2.4.10 Views expressed at FDA hearings
Industry has also attempted to share its views related to ways in which regulated industry
should operate on the internet and social media with FDA more directly. Of particular
value can be the transcripts from FDA hearings such as that related to the “Promotion of
FDA-Regulated Medical Products Using the Internet and Social Media Tools” discussed
previously, held in November 2009. To facilitate the analysis of industry’s position, I
conducted a content analysis of transcripts from over 70 presentations to FDA. The
transcripts were grouped into categories to help understand and navigate the diverse
information that they contained. A minority of the transcripts addressed possible
solutions to assist policy development and implementation from proposing a universal
adverse event reporting widget to continuing dialogue on the subject. However, most
discussion focused on industry concerns, with the most contentious being the lack of
clarity from the FDA on working with social media. The discussions can be summarized
in four key topic areas, shown in Table 2 (FDA, 2009c).

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Table 2: Summary of information from FDA hearing on social media (FDA, 2009d)
Topic Summary of the Discussion
1. The FDA should
provide clear,
social media-
specific guidance.

Current guidance overlooks the power of the internet to promote
health care and is keeping sponsors out of the dialogue.
FDA must evaluate the impact of not providing guidance.
Industry is currently paralyzed or sidelined by regulatory
uncertainty. This allows poorly informed third parties to be
perceived as experts, and to drive most online discussion, often
resulting in misinformation.
2. Manufacturers
should be
responsible for
sites they own,
sponsor and/or
influence
Companies should be accountable for content that they create,
control or promote (incl. sponsored or otherwise financially
influenced third-party content), BUT it is unreasonable for
companies to be accountable for content over which they do not
exert editorial or financial control. User-generated content, a
key component of the internet and social media should not be
considered advertising or promotion for regulatory purposes.
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Topic Summary of the Discussion
3. FDA should
respect the 1-click
rule whereby
safety information
may reside on an
adjacent page
easily reachable
through one clear
hyperlink.
The one-click rule for linking to safety information was
supported widely as a solution for media formats with limited
space.
Google and Yahoo! addressed the unintended consequences of
the recent Notice of Violations from FDA which prompted
companies to stop running product claim advertising on
sponsored links; the ads prior to the NOVs were transparent and
informative. Yahoo! and Google provided recommendations for
addressing the need to make safety information accessible while
allowing for transparency in Search Engine Marketing.
4. Monitoring the
internet for
information
regarding off-label
use and adverse
events (AE)

Listening to on-line safety related content is good for public
health. However, methods are unclear. Companies that troll
internet and social sites for potentially reportable AEs may have
an increased volume of AEs that they are required to report.
How far can and must companies go to obtain further
information when many internet users expect and value
anonymity? Does the effort differ depending on whether the
site is one which the company owns, one which the company
sponsors (100% or partial), or merely a 3
rd
party site on which
the product is mentioned? FDA must expand efforts to engage
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Topic Summary of the Discussion
with the internet providers to encourage AE reporting to
Agency.

Most presentations to FDA emphasized the need to consult with stakeholders, while
moving quickly on policy development. The industry appears to be concerned that
failure to give good guidance will have unintended consequences. Failure to provide
good guidance in this case includes both the situation in which guidance is too lenient,
thus fostering inappropriate practice, and the opposite situation in which draconian
restrictions on industry would silence a key stakeholder in advancing public health.
2.4.11 Articles in Journals and Trade Press
The challenges of social media are relatively new, and thus are discussed more frequently
in the trade press than in the research or scholarly literature. The focus of some articles
in the trade press reinforce many of the messages identified above, and often raise
questions about how the existing regulations can be applied to promotion in this new
space (Hay & Wilkenfeld, 2011). Other articles attempt to guide new industry users
regarding the methodologies and benefits of engaging in social media from a commercial
perspective (Mangold & Faulds, 2009). Some articles also identify and analyze trends
regarding the increased use of social media as a tool for assessing medical information as
well as disease conditions and treatment modalities (Aitken, Altmann, & Rose, 2014) or
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for clinical research (Lamberti, Stergiopoulos, Paulima, & Getz, 2014). Notably, most
studies have focused on the pharmaceutical subsector rather than the medical products
sector as a whole.
In academic journals, most articles have focused on the history of FDA’s role as
regulators of DTC advertising. They are found primarily in legal literature, where they
critique FDA’s approaches to compliance in the absence of specific legislative rules
(Richardson, 2012), legal implications of related to DTC advertising and the role of FDA
and FTC in the promotion of pharmaceutical product and public policy issues (Calfee,
2002).
2.4.12 Current Status of Industry Promotional Activities
Historically, most medical product promotion has involved face-to-face interactions with
health care personnel, but more recently, a shift toward e-detailing and the use of other
media channels to reach users has been seen, in part due to the difficulty that new rules
and restrictions on access to doctors have presented (Andreani, Rokka, Moulins, &
Conchon). Further, the traditional mode of advertising to patients through direct mailings
and print advertising has changed as other options of communication evolve
(GBIResearch, 2012). However, industry faces logistical concerns when trying to
promote through internet channels. Thus, it can be difficult for industry to comply with
similar regulatory standards as print advertisement, because of issues such as space
limitations, for example. Communications using social media are typically short.
Twitter permits only 140 characters in its tweets. Facebook advertisements are typically
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limited to 25 title and 90 text characters (Facebook, 2012). In such limited space it is
difficult to detail information about risks and benefits in accordance with requirements in
21 C.F.R. § 202.1(e)(1). Other challenges include: concerns about the use of the new
medium more generally- how to constrain and educate users about false, fraudulent, and
deceitful information leading to potential public health threats; how to best present
information in the new abridged formats; how to deal with those with limited health
literacy; how to deal with the loss of control over the creation and editing of company
content; and how First Amendment rights can be exercised in the social media space.
2.4.13 How Industry is Coping
The opportunity to use the internet as a way to promote medical products is obviously
important, but has been approached carefully by the industry. In the article,
“Pharmaceutical Marketing and the New Social Media”, Greene & Kesselheim (2010)
speculated that the reluctance to use social media reflects uncertainty about the
regulatory implications, consistent with the historical approach of industry “to wait for
the FDA to establish explicit codes of acceptable marketing practices before devoting
substantial resources to social media”. Nevertheless, some pharmaceutical companies
have started to increase their spending in social media (Greene & Kesselheim, 2010).
Current examples of pharmaceutical companies that have embraced social media include:
Pfizer, Johnson & Johnson, Novartis, Bayer, Glaxo-Smith Kline, and Merck (Callari,
2009), all of which currently operate Twitter accounts (Table 3).
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Table 3: Examples of pharmaceutical companies’ social media sites
Company Social Media Channel Link
Pfizer Twitter http://twitter.com/#!/Pfizer
Pfizer Youtube http://www.youtube.com/PfizerNews
Pfizer Facebook http://www.facebook.com/Pfizer?sk=wall
Johnson &
Johnson
Twitter http://twitter.com/#!/JNJComm
Johnson &
Johnson
Youtube http://www.youtube.com/user/JNJhealth
Glaxo-Smith-
Kline
Twitter http://twitter.com/#!/gsk
Glaxo-Smith-
Kline
Youtube http://www.youtube.com/user/GSKvision
Novartis Twitter http://twitter.com/#!/novartis
Bayer Twitter http://twitter.com/#!/BayerUSNews
Merck Twitter http://twitter.com/#!/MERCK

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Other avenues are also being explored. For example, Eli Lilly launched a blog on
Medscape, authored by its medical team but limited to sharing information with
physicians about their experiences and opinions. The site avoids comments that mention
product specifically because of the recent experiences with warning letters issued by the
FDA with respect to off-label dialogue, as discussed previously (Barlas, 2010).
AstraZeneca established a few branded video channels on YouTube several years ago and
more recently joined Twitter. Earl Whipple, senior director of business and digital media
communications at AstraZeneca US, said,
Before we launched our @AstraZeneca US Twitter account, our company
was already the subject of numerous tweets, so it only made sense to join
the conversation. We not only want to be part of conversations about
AstraZeneca and important health topics, but we also want to listen to
what people are saying about the company and the industry (Grant, 2009)

Trends suggest that the pharmaceutical industry is shifting its focus from television
towards digital channels (Arnold, 2013) and the industry is expected to increase spending
on promotional use of social media (Nielsen, 2013).
At the same time, however, many medical product companies have abstained from using
social media to engage customers and stakeholders. Instead, most have chosen to use a
Web 1.0 model, a more traditional one-way method of messaging that restricts customer
interactions, or to use advertisements that do not mention the name of the medical
product. Bill Evans, managing editor of the healthcare-focused social media blog,
DoseofDigital.com, believes that lessons learned from FDA Warning letters combined
with fear of uncertain regulatory risk limit the broad adoption of social media (Richman,
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2012). He states that many pharmaceutical companies are pursuing a “culture of fear”
and practicing the “precautionary principle,” which can be stated simply by the statement,
“if an action might cause harm, inaction is preferable.”
To take advantage of this fear, a new set of businesses have emerged to credential
regulatory compliance for internet promotion in anticipation of the FDA’s social media
guidance. Educational programs also flourish. For example, an online certificate program
developed by the Center for Communication Compliance (CCC) is being taught by
former FDA officials. According to industry veteran, Wayne Pines, agencies providing
communication services in advertising/promotion and promotional medical education are
recognizing the importance of demonstrating proficiency of regulatory compliance
fundamentals through certification to minimize risk (Hay & Wilkenfeld, 2011).
Consumers may not respond to media technologies in ways that are predictable.
Furthermore, user habits evolve over time; social media sites and platforms that are
popular today may quickly be replaced by new technologies with which the consumer
may interact quite differently, in the same way that we have seen with the recent
evolution of interactive blogs and twitter feeds. Although such challenges are clearly
recognized by industry, companies are nonetheless making efforts to embrace the new
technologies in ways that benefit sales, in a marketplace increasingly crowded by
shortened patent lives and aggressive generic competition. Thus, industry appears to be
interested in sharing pertinent information regarding their social media experience as a
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basis upon which to apply existing regulations and to identify areas that warrant
additional FDA guidance.
In summary, the review of stakeholder opinions in the literature above suggests that
stakeholders have strong and diversified views. Of the primary stakeholders, perhaps the
least studied opinions are those of industry. Most of the information now available
comes from professional industry associations or from a few large companies,
particularly pharmaceutical companies, and often address narrow aspects of social media
use. Thus, it is unclear whether these views are typical of companies generally. This
research study will therefore assess the perspective of the industry about the types of
FDA guidance that would bring clarity and transparency to the acceptable use of social
media for promotional and educational purposes.
2.5 Frameworks for Research
A specific conceptual framework for studying the strengths and weaknesses of policies
relating to DTC advertising using social media has not been recognized in the literature to
the best of my knowledge. The literature review above provides a starting point, but a
more systematic evaluation of industry views would deepen this understanding. To
ensure a stronger foundation for this research, it is useful to identify a framework that can
serve as a basis for a comprehensive survey tool.
The framework that will be used in this thesis has four elements that are often considered
as core to the effective development and implementation of the elements are neither
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mutually exclusive nor even exhaustive, but they have been used by others to base
investigations of industry views. The four elements reflect fundamental objectives of
regulation: 1) to ensure the safety and effectiveness of medical products, 2) to improve
access to useful medical products and associated information, 3) to facilitate compliance
by industry and enforcement by regulators through clear, transparent policy instruments,
4) to assure a level playing field.
Figure 9: Framework for current research

Three of the elements identified here are common to a framework developed by
Redington who identified the following policy instruments (1) economic and access, (2)
patient relief, (3) rules of participation and (4) congressional action as important frames
to affect orphan drug reform from 1990 to 1994 (Redington, 2009). Ramsey (2013)
mapped these elements onto a triadic model that identified (1) safety & effectiveness, (2)
efficiencies in research commercialization, and (3) equalization of requirements and
Theory of
Regulation
Safety &
Effectivenss
Compliance
Level Playing
Field
Access
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standards for industry as key objectives of regulation in a survey investigation of the
impact of incomplete monograph in the over-the-counter drug industry (Ramsey, 2013).
Both Redington and Ramsey models identify key objectives in regulation needed to
facilitate the approval of safe, effective, innovative technologies.
The three elements recognized by both Redington and Ramsey can be important goals of
FDA regulation that can be recognized in FDA materials. The importance of the first
element when developing regulatory policy, to assure patient safety, is evident
throughout the vision and mission statements of the different branches of the FDA
offices.
FDA vision is that medical products are safe and effective; and the public
health is advanced and protected. FDA’s mission is to protect consumers
and enhance public health by maximizing compliance of FDA regulated
products and minimizing risk associated with those products (FDA,
2014a) ….. FDA is also responsible for advancing the public health by
helping to speed innovations that make medicines more effective, safer,
and more affordable and by helping the public get the accurate, science-
based information they need to use medicines and foods to maintain and
improve their health (FDA, 2012b)

The second element, to improve access to medical products and particularly novel
technologies, has had much recent attention as a particularly important goal. This element
has a more business-friendly focus in that it “enables patients to access novel products
while promoting economic growth, innovation, competitiveness, and job creation among
the industries regulated by this Act” (Coats, 2011). It underlies certain recent policy
initiatives, such as that related to the development of a risk-benefit framework that would
recognize products whose benefits are particularly important (AHPSR, 2012). It is also
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apparent in the new rules for “breakthrough technologies” and established rules for
orphan products. For orphan products, as an example, the FDA exempts industry from
proving that demonstrably safe devices are effective, under the humanitarian device
exemption (HDE) guidelines (FDA, 1996).
The third goal of regulation, to level the playing field to the extent possible, is also seen
as an explicit goal of FTC, but is also implicitly acknowledged by FDA. Embedded in
this element is the notion that small and large companies must have the same degree of
access to information and advice as large companies and that there is a common standard
with regard to transparency and support. In their report titled Ensuring Safe Foods and
Medical Products “Through Stronger Regulatory Systems Abroad, the independent,
nonprofit organization, Institute of Medicine, recommended that a core characteristic of a
regulatory system must be its predictability. This ensures that rules are applied
consistently and fairly and do not provide an advantage for small nor large companies. If
robust, the system should ensure equitable enforcement in a consistent manner based on
scientific evidence (Riviere & Buckley, 2012).
The last element, and one that does not appear in the triad of Redington and Ramsey, is
the goal of assuring appropriate behavior through the assurance of and oversight
compliance. Difficult or opaque regulations may have the intent to produce useful results
but may not be useful if they are too difficult to implement or enforce. This element is
built on four structural components: (1) laws that specify the expected behaviors, (2)
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standards or guidance for compliance, (3) sanctions for non-compliance, (4) and
administrative or policing systems to enforce the laws (May, 2003).
In this study, the framework referenced above will be used to explore the views of
industry with respect to regulatory guidance and current practices.
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CHAPTER 3: METHODOLOGY
3.1 Introduction
This qualitative, exploratory case study used a mixed methods approach to study industry
views on FDA’s policies and activities with respect to promotion of regulated medical
products using the internet and social media. The first phase, carried out in chapter 2,
collected and reviewed a variety of documents to establish a background regarding the
stakeholder views related to FDA regulation of advertising and promotion, including
social media. In the second phase, a structured survey tool was developed. The survey
questions were guided by a framework that featured four elements commonly identified
in literature related to the goals of regulatory policy. A focus group was then assembled
to review the construct and content validity of the survey and overall design of the
questions. In the third phase, industry professionals were identified as key informants and
surveyed through electronic survey distribution.
3.2 Development of Initial Survey
The online survey tool in this study used the Qualtrics survey software “Survey Research
Suite”. The questions were developed to explore the perceptions and views of the study
participants in specific topic areas that were based on literature research and informal
discussions with individuals with experience in the field of social and regulatory science
approaches. The survey was then reviewed by sampling regulatory professional
colleagues at 1:1 meetings (n=3 minimum) from my place of employment. The
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instrument (~20 questions) was validated by a focus group of about ten experts in the
field. The instrument may also have been subjected to legal and regulatory review by the
employers of some of the pharmaceutical industry participants.
The focus group took place at the USC ICRS in Los Angeles, California. The
approximate duration of the focus group was 105 minutes and the proceedings were
captured by video recording. Because some participants attended from remote sites,
video conferencing (with participant consent) was offered to facilitate the interactive
experience of remote participants.
Participants were emailed a copy of the sample survey instrument and a high-level set of
instructions regarding travel and focus group details was provided no less than one week
in advance of the focus group date. The proposed Agenda for the focus group is presented
in Table 4 below. The moderator presented an overview to describe what participants
should expect during the focus group discussion, the process that will be followed, and
the expected outcomes. The assessments of each of the proposed questions ensued,
followed by a brief period for participant feedback. Once all questions were reviewed,
general feedback on the format and content of the instrument was discussed. The
moderators summarized the areas of feedback and specified actions useful to refine the
survey further. The final survey was revised electronically using Qualtrics.

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Table 4: Focus Group Agenda
Agenda
1 Short Overview

Moderator (Kobby Dankwah) – 10

2
Review Each Question / Participant
Feedback difference of opinion”

Participants / Moderator – 80 min
3 Discuss General Feedback

Participants / Moderator – 10 min
4 Discuss Unexpected Feedbacks /
Review Specific Actions for Survey
Moderator (Kobby Dankwah) – 10
min

3.3 Survey Deployment and Analysis
The survey’s initial target population was industry professionals (regulatory affairs,
marketing, public affairs etc.) either currently or previously with experience in
advertising and promotion for the medical product industry. Participants were selected
based on pre-determined inclusion criteria. Participants were expected to have at least
three years of medical device or pharmaceutical industry experience (e.g., public affairs,
legal regulatory/or regulatory affairs, marketing). Representatives of regulatory
authorities were excluded from the respondent pool. Potential participants were
identified through professional networks, conferences and work-related activities. All
were screened for their willingness to participate via phone/email and anonymity was
guaranteed to encourage participation. Because the number of individuals experienced
with the regulation of advertising and promotion was relatively low, this exploratory
study utilized a snowball technique to recruit additional participants aided by existing
participants’ recommend colleagues who may be qualified to participate. This technique
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helped expand the potential pool or respondents quickly. The survey was distributed
electronically with reminders given after two weeks when responses were not yet
obtained. Care was taken to assure, where possible, that the survey was mailed to an
email address that without automatic spam filters, such as those typical in large
companies. Neither the electronic survey responses, nor the information provided were
attributed to the individual participants, and the names of the participants and their
employers will remain anonymous. No recompense for participating was given, but
respondents were promised a copy of the results when complete. To improve response
rate, the survey deployment relied on both direct contact and snowball techniques.
Specifically, an email was sent to people that I knew or people recommended to me to
solicit their participation. Surveys were only sent to those who responded affirmatively to
the request. Once they said yes, the survey was sent using the electronic survey tool
Qualtrics, and then a follow up e-mail was sent to a few respondents a few days later. I
sent the same group of participants a second follow up e-mail asking them if they could
recommend anyone else who might be willing to do the survey.
The Qualtrics software used for data collection is equipped with a relatively sophisticated
statistical analysis package and was used to carry out statistical analysis of the raw data
where appropriate. Given the qualitative nature of this study and its non-experimental
design, analysis was limited to basic statistical outputs: percentages, standard deviations,
variance and means of data.
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CHAPTER 4: RESULTS
4.1 Results of Focus Group
The purpose of the focus group was to discuss the perspective of focus group members
on whether the draft survey was appropriate to address the research topic and whether the
distribution methods would be able to assure a good response rate prior to deploying the
survey to industry recipients. The draft survey was distributed to the focus group. The
focus group session included members who participated in the 90 minute session both
face-to-face and via WebEx and was conducted at the University of Southern California,
International Center for Regulatory Science on March 12, 2014. Discussions ranged from
considerations of demographics, functional areas, product areas and specific questions
related to the use of social media in advertising & promotion of medical products. The
focus group recommended several modifications to the draft survey and suggested
additional questions to strengthen it. The focus group members recommended capturing
information related to the department or group responsible for overseeing the use of
social media in the company. Question 1 was revised from “what is your title” to “what
title is aligned most closely with your current responsibility”. They also recommended
including commercial operations and marketing as a potential functional group
responsible for review and approval of social media (Question 2). The focus group
raised concerns that small companies may not have the necessary resources to support
social media although they may be prolific in disseminating materials in social media
environment. They recommended that this issue be explored by adding a question to
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capture whether social media was either fully, partially or not outsourced by medical
product companies (Question 6). They also recommended adding a question that would
address the level of involvement in social media (Question 8), to gauge whether different
sets of answers will be captured depending on the functional area of the respondent, so
that data could be stratified by product area. One focus group member suggested to add a
statement at the start of the survey to assure that participants were aware they should
participate in the survey only if they met the desired acceptance criteria relating to their
familiarity with the use of social media. There was discussion on whether the type of
product (e.g., device, drug) was important to capture. It resulted in the recommendation
to change the product categories by mapping them to the relevant FDA division of
devices, drugs, combination products, biologics or other. A subordinate question to
Question 7 was recommended in order to explore reasons the company planned to
increase or decrease its participation in social media. The group also recommended
expanding the question related to how consumers receive reliable and timely information
to include a choice of patient advocacy or support groups (Question 17 & 18). The
questions were re-ordered to enhance the flow of the survey. In the final section, the
group recommended adding a question on whether the participants were familiar with the
recent FDA guidance, Fulfilling Requirements for Postmarketing Submissions of
Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,
to ensure individuals not familiar with the guidance were not presented with additional
questions related to that document (FDA, 2014c).
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The members also deliberated on expanding the survey functional areas in the survey to
include Commercial Operations and Strategic Marketing since these areas are
significantly involved in promotional activities with respect to social media. The
members furthermore recommended that the questions be structured carefully because
some potential sensitive questions relative to warning letters, corporate strategies and
practices could require disclosure of potentially confidential or sensitive information, and
this might cause some survey respondents to abort their participation in the survey (Cho
& Larose, 1999). This recommendation was incorporated into Question 2. The final
version of the survey incorporating focus group suggestions of is shown in Appendix A.
4.2 Analysis of Survey Respondents
4.2.1 Profiles of Respondents
The online survey was deployed between May 15 and July 21 2014. Sixty-eight survey
links were sent, of which 51 participants completed the survey with a response rate of
75%. Follow-up e-mails to potential respondents were important in increasing the
number of survey responses. One participant initially thought the survey was a “spam”
message and asked for confirmation before completing the survey. A number of
respondents (n= 17) opened the survey but did not complete or partially completed the
survey, even though they initially opted to participate. One respondent, an attorney, felt
it did not make sense to participate because he was not involved directly in relevant
activities such as manufacturing and promotion. Another participant also did not
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complete the survey because he felt that as a consultant, he did not have sufficient
experience in the use of social media for promotion.
The majority (82%) of the survey respondents were currently at a manager level or above
at the time of survey. No respondents had titles of Chief Executive officer (CEO) or
Compliance Officer. The remaining 18% (9/51) self-selected their roles as Counsel,
Coordinator and “other” functional areas. The “other” categories included individuals
who self-identified as Project Manager, Senior Regulatory Affairs Specialist, Specialist
and Consultant (Figure 10).
Figure 10: What title is aligned most closely with your current responsibility?

Half of the respondents (50%) were from regulatory affairs and approximately one-third
(22%) were from commercial operations. The remainder was from by strategic
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marketing (14%), public affairs (8%), quality (4%) and legal regulatory/compliance (2%)
(Figure 11).
Figure 11: What is your job function? Please choose the best answer

The majority of respondents identified that responsibility in their company for the control
and approval of social media was held by Regulatory Affairs (58%), but some identified
the function as centered in Public Affairs (10%), Strategic Marketing (10%) or Legal
Affairs/Compliance (4%). Only one individual associated this function with Quality
Assurance. A number of the respondents who choose “other” stated that multiple groups
are involved (Figure 12).
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Figure 12: Which group in your current organization controls social media promotional
review and approval?

The survey respondents were drawn from companies of different sizes as gauged by
revenues, but most (75%) worked for companies with annual revenue >$1 billion and
86% worked for companies with revenues >$500 million. Of those who responded, only
a few participants worked for companies with annual revenues of less than $10 million
(2%). Those who worked for companies with revenues from $101 to $500 million and
those between $501 million to $ 1 billion each accounted for 12% of the sample (Figure
13).
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Figure 13: What is your company's annual revenue (in U.S. $)?

The majority of the respondents (90%) had device experience. Equal number of
respondents (18%) had experience in prescription drugs, combination products and other
product categories (16%), which included nutritionals, vision, veterinary and over-the-
counter products. The percentage of respondents with biologics experience was 5%
(Figure 14). Some respondents identified experience in more than one sector. The fact
that more than 75 product categories were selected by 51 respondents suggests that many
respondents have experience in more than one product category.
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Figure 14: In which product categories are you involved?

When respondents were asked whether their promotional activities were outsourced,
about two-thirds (67%) of the respondents said they were and 31% said they were not
outsourced. Only one single respondent (1/51) identified that promotional activities were
wholly outsourced.
Beyond social media, web media (82%) were identified as the most common avenue used
for DTC advertising. Magazines (65%) were identified to represent the second largest
category. Television (59%) was the third, followed by newspaper (29%) and radio (25%)
advertising. Notably, 14% of the respondents indicated that they do not use DTC
advertising. Other media types (8%) included postcards and newsletters (Figure 15).
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Figure 15: Other than social media, which media channels do you use for Direct to
Consumer Advertising (DTC)? Please check all that apply

When respondents were queried on their level of involvement in promotional activities
using social media, the largest category of respondents, 75%, selected recommending
strategy and 61% identified that they approved social media content. Twenty-nine
percent (29%) indicated that they monitored compliance, and 25 % created social media
content. Equal numbers (14%, for each answer) of respondents indicated that they either
participated on line or selected other. The other category included, “approval of content
if only product related”, “review and approval of content” and “coordination with
marketing” (Figure 16). Several respondents identified more than one answer; as such the
total responses identified in this figure are higher than the number of respondents.
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Figure 16: What is your level of involvement with regard to promotional activities using
social media? Please check all that apply

The largest number of respondents, 73%, selected Facebook when probed about social
media channels that they were using Microblogs (e.g. twitter) and You Tube were
selected by 65% and 58% of respondents respectively. Of the 51 respondents, 45%
indicated they use blogs and 28% used discussion forums. The “other” category was
identified by 20% of respondents and included Vine, Pinterest and Instagram (Figure 17).
The fact that more than 100 channel selections were made by 40 respondents suggests
that many companies are using more than one channel.
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Figure 17: If you are using social media, please check all of the channels that apply

When respondents were asked to address specifically their present or planned activities
related to use of social media based on ten possible options, the responses varied. More
companies presently use or plan to use social media in all customer engagement areas.
The majority of respondents reported their company either use or plan to use social media
to provide product information to engage customers (47 respondents). This was followed
by provision of customer service information, gathering customer experience (36
respondents each), solicit customer feedback (32 respondents), provide education to
recognize disease state (30 respondents), provide education/games to promote healthy
behavior (29 respondents). However, numbers in the two categories were equal when
considering the category, “provide support for group opportunities” and provide
discounts/coupons (23 respondents). Somewhat less frequent were uses including:
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provide reimbursement information (16 respondents) and provide treatment reminders (8
respondents) (Figure 18).
Figure 18: Does your company use or plan to use social media in the following areas to
engage customers?

When respondents were asked to rank the objectives they felt motivated their company’s
engagement in social media, building awareness was the most preferred option with a
mean ranking of 1.83. The low score reflects the fact that most respondents selected this
option as first or second. Progressively less favored were the choices: increase product
adoption (3.51), influence customer perception (3.64), grow and maintain consumer
relationships (3.94), increase sales (4.23), enhance risk and reputation (4.38) reduce
attrition (6.62) and other (7.85). Text responses that added other goals included:
“responding to recall information, customer inquiries, increase presence in
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blogs/forums”, “address competitors, create online support community” and “increase
engagement with brand” (Figure 19).
Figure 19: What core objectives does your company consider when deciding to proceed
with social media promotion? Please rank with most preferred item on the top

When respondents were asked about their company’s level of participation in social
media in the last 2 years, 42% and 34% of respondents identified a major increase and
minor increase, respectively. One-fifth (20%) of the respondents reported no change.
Only one respondent reported a major decrease, and another reported a minor decrease
(Figure 20).
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Figure 20: In your experience, which statement best describes your company's
participation in social media in the last 2 years?

Of the number of respondents (n=21) who chose major increase, the most commonly
reported reason (38%) was to build brand awareness. Twenty-four percent (24%) of the
respondents indicated the projected major increase was undertaken to overcome the
limited interactivity of traditional media. Other reasons identified by a few respondents
were to exploit cost efficiency of social media (14%) and increase sales (4%). Other
reasons (20%) expressed by respondents as text responses included: building online
community, global adoption, heightened engagement and increasing competitor’s
presence in social media (Figure 21).
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Figure 21: If you chose major increase, what was the reason?

Only one respondent cited a major decrease in social media due to the “lack of guidance
from outside regulatory authorities/bodies”.
When respondents were asked to rank the importance of eleven challenges with respect to
the commercial use of social media, regulatory compliance risk was ranked the most
important (3.14). This was closely followed by regulatory restrictions on customer
interaction (3.18). Respondents also saw challenges with monitoring, uncertain potential
to create value, and lack of clear guidance as lower in importance whose responses were
clustered around a mean of 5. Fear of enforcement actions, insufficient resources and
uncertain return on investment ranked amongst the least influential reasons. There were
no specified text responses to illuminate the selection of other (Figure 22).

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Figure 22: How important are the following challenges with respect to the commercial
use of social media. Please rank the following from most important to least
important.

When respondents were asked to rank the importance of different types of social media
use, marketing was typically selected first or second, as reflected in its average ranking of
2.09. However, social and customer care (2.18) and reputation management (2.41) were
rated in a close second and third position respectively, followed by feedback from
customers/stakeholders (3.32) (Figure 23).

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Figure 23: Please rank the importance that your company places on the following in the
uses of social media from most to least important with 1 being the most
important.

When asked about the sources best suited to provide a vehicle for consumers to receive
timely information on product safety, company website ranked the highest source (2.33).
This was followed by the FDA website (3.22), consumer blogs (3.33), and patient
advocacy groups (3.47). Web MD or similar (4.22) and website of closest competitor
were rated the least (4.42) (Figure 25). However, when respondents were asked about the
sources best suited to provide a vehicle for consumers to receive timely information on
product reliability, the FDA website (1.88) was rated marginally higher than the
company’s website (1.93). This was followed in order by the choices: Web MD or
similar (3.98), patient advocacy support groups (4.07), consumer blogs (4.51) and
website of closest competitor (4.63) (Figure 24).
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Figure 24: As a vehicle for consumers to receive timely information on product safety,
how would your company rank the following channels for dissemination of
information with 1 being the most timely?

Figure 25: As a vehicle for consumers to receive reliable information on product safety,
how would your company rank the following channels for dissemination of
information with 1 being the most reliable?

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When asked in an open text format to explain what the company does with data from
social media, 38 respondents reported reasons that appeared to be focused in four main
categories:
(i) to inform product performance and development of medical products,
including new product development and product enhancements,
(ii) to benchmark compliance, including complaint handling and monitoring,
(iii) to evaluate and enhance brand awareness and
(iv) to serve as a tool for marketing and market research.
Selected responses by type are included in Table 5. Conversely, when respondents were
asked to explain their views on business advantages associated with social media, most of
the responses were clustered in four key areas, including: product performance and
development, compliance, branding and marketing/market research. One respondent
listed the lower cost as a business advantage (Table 6).
Table 5: What does your company do with data from social media? Please explain.
(Selected responses shown by response type).
Comments related to product performance and development
“New product ideas/concepts.”
“Understand product performance and feedback for next generation products.”
“Review in teams and disseminate feedback to organizational teams for improvement or
new technologies”.
“Leverage it to inform product improvements, better meet consumer preferences, refine
marketing mix”.
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Comments related to compliance
“Monitor for SAEs, compile for marketing use.”
“For complaint handling, inputs to product improvement or future product development,
inputs to process improvement, etc”.
“For complaint handling, marketing and new product development purpose”.

Comments related to brand
“Information is used to determine the most effective and most popular social media sites,
and to build knowledge on what customers are saying about our company and our
products”.
“Inform decisions on content strategy for our specific purposes and measure brand
perception / sentiment.”
“The data is used to gauge customer satisfaction and retention, brand awareness and
product positioning.”
“They monitor how much activity we get and tie that to brand awareness”.
“Data collected is mostly in the form of outreach potential”.
“Analyze patterns, feedback, insights”.
“Monitor consumer reach, engagement, and sentiment to inform brand marketing
(company & product level), manage corporate reputation, monitor key influencers, etc”.
“Measure interest in programs”.

Comments related to marketing and market research
“Build strategies for targeted marketing and compare company vs. competitors'
participation in social media.”
“We use it for market research”.
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“For future product planning based on customer feedback and comments”.
“We use anonymous insights for internal learnings”.

Table 6: What are your views as the business advantages associated with participating in
social media? Please explain. (Selected responses shown by response type).
“Rapid/viral communication channel (for good or bad)”.
“The advantages include low start-up costs, increased awareness of the company and
products, and reaching a wider audience quickly”

“The cost efficiency of promoting in social media along with the ease and value of
interaction with customers”.

“Low start-up costs, gain brand and company awareness broadly vs. traditional media,
easy and fast access to and dissemination of information”.

“Brand reputation; being able to serve our community by listening and providing useful
information that helps the community”.

“It's a timely way to determine how your product is doing with consumers and product
awareness”.

“Faster and cheaper reach to consumers; tapping into key opinion leaders and trend
setters among consumers”.

“Improving company image and reputation, engaging directly with users, getting timely
market feedback, and having an effective way of disseminating information, etc”.

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“Another avenue to reach the patient and provide timely information, for the customer it
may decrease their cost of obtaining information”.

“Represents a major (and growing) channel through which consumers are viewing media,
in developed and emerging markets. Facilitates deeper consumer engagement vs.
traditional media. HUGE earned media upside and opportunity to drive positive
advocacy. Enables

"adaptive marketing" / advanced analytics to maximize campaign effectiveness. Provides
deeper consumer insights, and is an effective tool for monitoring competitor consumer
engagement. Potential for earlier identification of regulatory related product issues”.

“Direct and unfiltered feedback from the consumer. Ability to positively direct your
brand's online consumer experience”. “A more convenient connection with our
customers”.

“So far, it is difficult to justify the business investment in platforms like Facebook,
Twitter, etc. especially for medical devices. In my view the more compelling ways to
participate in social media are having an excellent web page to educate consumers about
product, robust search engine optimization (SEO) tools to make sure consumers can find
the product, and a good online reputation for consumers seeking to understand the
product”.

4.3 Safety and Effectiveness Response
This section of the survey explored the way in which product safety and effectiveness
might be affected by the advertising and promotion of those products using social media.
First, respondents were asked to rank a list of concerns that might influence the decision
of their company to use social media and were given the option of “cannot answer”.
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Fear of regulatory non-compliance ranked as the most influential decision criterion based
on the mean ranking (1.14) from 44 respondents. In order of descending importance
were: public criticism and violations of privacy laws (1.52 each), disclosure of
proprietary information and ability to manage out of date/inaccurate information (1.55
each), fear of no turning back once a channel existed (1.80) and manpower costs (1.82)
(Figure 26).
Figure 26: Which of the following concerns would influence your decisions regarding the
ways that your company use social media?

When respondents were presented with five possible choices to rank as the most suitable
way to present balanced risk-benefit information regarding a medical product on social
media, a majority of respondents (36%) chose the option of providing the user with a web
link that directs the user to the complete risk/benefit statement. This was followed closely
by the option to include summary of risk/benefits (33%). The option to include the
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complete risk/benefit statement in the promotion was 22%. Only a few respondents chose
the options to either provide manufacturer’s contact information to procure the
risk/benefit statement (4%) or to include a summary of risk/benefits and a link to the
complete risk/benefit statement or combination of the options based on text responses
(4%) (Figure 27).
Figure 27: Of the following choices, which do you think is best suited to provide a
balanced presentation of both risks and benefits of medical products?

When asked if current regulations restricting company use of social media deprive
patients of important safety and efficacy information, about one third of the respondents
(31%) felt that the restrictions reduced access to important information, whereas about
one fifth (18%) felt that restrictions make product safer, and 13% felt that restrictions
would have no effect. A significant number (38%) were unsure about the effects of
regulations (Figure 28).
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Figure 28: Do you think that regulations that currently restrict company use of social
media deprive patients of important safety & efficacy information?

4.4 Level Playing Field
This part of the survey asked four questions that examined respondents’ views on the
degree to which the regulations provided a level playing field in the market.
Respondents were asked first how their company would most likely deal with a situation
in which they discovered a competitor was not compliant with DTC advertising
regulations; 51% and 42% indicated they would communicate formally to the company
or report to the FDA respectively. This was followed by either more vigorous actions
such as sending a cease and desist letter to competitor (30%) for initiating a legal action
(7%). In a small number of cases, the respondent indicated that the company might take
no action at all (14%). A small number of respondents chose “other” (16%), and
included text responses such as: to “take whatever action is required by regulatory
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authorities”, “not sure, depends on the severity and impact of the violation”, “not sure,
depends on the extent of non-compliance and its assessed impact on consumers” and
“inform corporate of the situation and them decide on the next steps” (Figure 29).
Figure 29: How would your company most likely deal with a situation in which it
discovered that a competitor was not compliant with DTC rules?

When respondents were further queried whether their company would escalate its actions
if the competitor’s actions were believed to affect patient/public safety, 84% and 2% said
yes and no respectively. Six respondents (14%) said they did not know the answer.
Respondents were asked to rate their level of agreement with the statement, "The FDA
issues enforcement actions more frequently against large companies versus small
companies". Approximately half (53%) agreed with the statement and fewer than 16%
disagreed. Thirty-one percent (31%) appeared to be neutral (Figure 30).
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Figure 30: "The FDA issues enforcement actions more frequently against large
companies versus small companies" Do you agree with this statement?

When asked to rate the most effective social media forum for promoting medical
products, You Tube was judged on average to be the most effective social media channel
based on a mean ranking of 2.81 amongst 43 respondents. This was followed closely by
Facebook (2.84), discussion forums (3.00), blogs (3.14), and microblogs (3.53). The
choice of “other” was typically last and no additional alternatives were specified (Figure
31).
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Figure 31: Which social media forums do you view as the most effective in promoting
your product, with 1 being the most effective?

4.5 Access
Respondents were asked whether their companies were likely to increase social media
spending over the next three years. Most respondents (89%) believed their company
would be somewhat or very likely increase social media spending (Figure 32).
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Figure 32: In your company's view, how likely is it that your company will increase
social media spending over the next 3 years?

4.6 Compliance
Results of previous sections suggest that companies were already well engaged in the
process of managing social media use. When respondents were questioned about
whether they had written procedures for governing their use of social media, the majority,
93%, responded yes, 4% responded no and one did not know (Figure 33).
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Figure 33: Do you have a written procedure governing the use of social media?

When asked which agencies would be best suited to oversee advertising in social media,
about half (54%) preferred FTC and the other half (49%) preferred FDA. Many of these
respondents chose both agencies together. A minority (24%) appeared to prefer self-
regulation. One respondent (2%) selected “other” but did not specify what other option
might be preferred (Figure 34).
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Figure 34: Some have suggested that promotion by social media should be governed by
an entity other than the FDA. Which group(s) would you prefer to oversee
advertisement and promotion using social media?

A range of views were expressed regarding the ability of industry to monitor social media
for adverse events. When asked to choose the best answer amongst a range of
possibilities, 47% and felt it was possible, 24% chose technically feasible, 16% chose
desirable and 13% chose reasonable (Figure 35).
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Figure 35: Do you think that it is feasible for industry to monitor social media for adverse
events?

When respondents were asked how FDA should regulate the interactions of a company or
its agents on social media interactions, about two-thirds (64%) of the respondents said
FDA should make submissions of promotional materials voluntary and 19% said FDA
should require the company to submit promotional materials to FDA before release.
Seven respondents (17%) expressed the preference for the submission of promotional
materials to FDA after release (Figure 36).
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Figure 36: How should FDA regulate social media interactions by agents of the
company?

Most of the respondents had never experienced an enforcement action based on their use
of social media (76%). However, a substantial proportion (24%) either did not know or
could not answer.
When respondents were asked whether current advertising and promotion rules were
suitable for their promotional activities, 36% and 40% of the respondents identified yes
and no respectively. Of the respondents (n=18) choosing no, the most commonly
reported reason (n=12) was related to the way that FDA currently expects the company to
confine its use of links to provide risk information. Only a few (n=3) respondents
identified contact customer service for risk information. Three chose other and suggested
provision of abbreviated summary where there is space limitation such as Twitter;
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regulations should cover the level of detail that can be provided to answer a patient
question, especially about safety and always referring patients to physicians.
Figure 37: If you chose "No", which of the following allows industry to fulfill the
adequate provision requirements?

4.7 FDA Proposed Draft Guidance on Social Media
When asked whether they were familiar with the draft guidance document for "Fulfilling
Regulatory Requirements for Postmarketing Submissions of Interactive Promotional
Media for Prescription human and Animal Drugs and Biologics", about one-fifth of
respondents reported that they were not very familiar, but the majority was either
modestly or very familiar (Figure 38).

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Figure 38: FDA has recently released the proposed guidance for "Fulfilling Regulatory
Requirements for Postmarketing Submissions of Interactive Promotional
Media for Prescription human and Animal Drugs and Biologics". Are you
familiar with the guidance?

Respondents had mixed answers regarding their level of agreement on views on the draft
FDA guidance. Respondents were asked to rank their level of agreement, ranging from
strongly agree to cannot judge, to answer on their view regarding specific statements.
When asked about whether the new guidance makes clear how to interact with social
media, the largest group of respondents (53%) chose “agree”. When asked if the
alignment between rules for social media and conventional media are appropriate, the
most common choice was “agree” (46%). When asked if the new requirements regarding
submission of interactive promotional media will encourage industry to use social media
more, equally common choices were “agree” and “somewhat agree” (35%, for each
answer) (Figure 39).
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Figure 39: What is your view on the following statements?

Respondents were mixed in their agreement or disagreement with regard to a number of
statements regarding the implementation of the guidance. Most respondents disagreed
rather than agreed that the guidance explains well how to use social media with space
limitations (e.g., twitter) (46% vs. 8%) and that the guidance provides an adequate
framework for my promotional activities (46% vs. 8%). Respondents were about equally
divided regarding the statement; the guidance makes compliance activities more difficult
than it was before (27% vs. 24%). A somewhat more negative view was associated with
the statements, the guidance clarifies reporting requirements for my company and the
guidance is clear on when enforcement discretion will be used by the FDA. On average,
18 respondents modestly disagreed that more resources will be needed by industry to
comply with the guidance (Figure 40).
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Figure 40: Please rate your agreement or disagreement with the following statements?

The next question asked respondents about areas in which their company would view as
problematic with respect to the FDA guidance. Fifty-six (56%) of respondents believed
the reporting requirements to FDA were extremely, very or somewhat problematic.
Sixty-two (62%) respondents believed that the scope of the “any control or influence”
test was extremely, very or somewhat problematic, whereas 50% believed making the
determination of when an employee or agent is acting on behalf of the company was
extremely, very or somewhat problematic (Figure 41).
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Figure 41: Which of the following areas does your company find problematic? Please
check all that apply.

When respondents were asked about their views on the overall impact of the guidance
document in assessing the regulatory risk of continuing or initiating the use of social
media platforms, 46% identified that they expected no change. However, 39% and 16%
identified that the impact would be better and worse respectively (Figure 42).
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Figure 42: What is your view about the overall impact of the guidance document in
assessing the regulatory risk of continuing or initiating the use of social media
platforms in the medical industry?

4.8 Cross-Tabulations
The survey respondents in the study included individuals from different professional
backgrounds and medical product industry sectors that varied in functional areas to assess
the impact of some of these variables on the answers given. Cross-tabulations were
performed to provide further examination of these areas. For those respondents working
for a manufacturing company at the time of the survey, there were concerns prior to the
research about how experience with specific product category may affect a respondent’s
answers, particularly in relation to the FDA draft guidance on social media.
Of all the attributes, the strongest relationship (p=0.71), was that identified when the
question “In which product categories are you involved? Please check all that apply”
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was cross tabulated with the question “What is your company’s annual revenue (in U.S.
$)”, showing that most of the respondents (65%) with medical device experience worked
for very large companies (> $1B), although not statistically significant.
For the second cross-tabulation, the question “What is your job function”? Please choose
the best answer”, was cross-tabulated with the question, “FDA has recently released the
proposed guidance for "fulfilling regulatory requirements for postmarketing submissions
of interactive promotional media for prescription human and animal drugs and
biologics". Are you familiar with the guidance?” The results indicated that respondents
working in regulatory affairs (54%) were more familiar with the proposed FDA guidance
when compared with quality assurance/compliance, medical affairs, legal
affairs/compliance, ethics and compliance, commercial operations and strategic
marketing. Nevertheless, the results were not statistically significant; the approximated P
value for this correlation was 0.91.
A third cross tabulation examined if any relationship existed by comparing a company’s
annual revenue to are your promotional activities outsourced, but there was no statistical
significance (P= 0.26). In a fourth cross tabulation to assess if a relationship existed by
comparing product categories in which companies are involved to traditional media
channels used for DTC, but there was no statistical significance (P=0.28).
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CHAPTER 5: DISCUSSION
5.1 Introduction
Similar to other regulated areas in the medical product sector, product promotion is
affected substantially by the regulatory environment. This study focused on the impact of
current US regulations and practices on direct-to-consumer advertising using social
media, through the eyes of those in the medical product industry. It explored whether the
current regulatory environment is seen to achieve the desirable outcomes of effective
regulations.
5.2 Methodological Considerations
When interpreting the results of this study, it is important to first acknowledge several
potential limitations and assumptions, including: 1) the representativeness of the sample
of respondents with respect to the broader population, 2) the appropriateness of the
survey method as a research tool, and 3) the nature and comprehensiveness of specific
survey questions.
5.2.1 Sampling Plan
One of the survey’s most challenging aspects was ensuring sufficient individuals with the
relevant background and experience were recruited as respondents. Respondents were
selected primarily on the basis of job level and experience in the medical product
industry. To obtain a broad sampling of individuals in different areas related to social
media promotion, respondents solicited included individuals from the functional areas of
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Regulatory Affairs, Public Affairs, Marketing, Legal Affairs/Compliance and Quality.
Most of those who responded, however, were in Regulatory and Public Affairs, as might
be expected because these functional areas serve as most commonly responsible for the
oversight of social media. No clear pattern of difference between the opinions of
different subpopulations was seen when data were cross-tabulated with respect to
functional area, although the sample in this exploratory study was small and might not be
expected to show any gross differences in opinion. What did seem to emerge was a trend
for the regulatory respondents to have better knowledge of the recent regulatory
documents, an observation not surprising given their specific responsibilities for
regulatory oversight.
The majority of the respondents (82%) had job titles of manager, director or vice
president, and thus represented senior professionals in the industry. Such a selection of
respondents was considered to be advantageous because these individuals would have
greater experience in the industry, and because opinions related to strategic as well as
logistical considerations might be captured by input from these different job levels. The
fact that respondents were affiliated with different job levels could be seen as strength but
also as a weakness. It potentially might limit insight into more fine-grain views of
different subpopulations and does not add the voices of those in early stage positions,
such as associate and specialist levels, who may have practical concerns related to
implementation of some rules (Cook, Heath, & Thompson, 2000).
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To avoid the common pitfall that the survey would not reach the respondent or would be
deleted as junk mail, it seemed important to secure the cooperation of the respondents by
using an introductory e-mail explaining the objective of the survey and the way in which
their contact information had been obtained. For those respondents who opted-in, an e-
mail was also sent with the survey link to ensure the potential respondents recognized the
message. In general, these measures were found sufficient to satisfy most respondents.
Nevertheless, the fact that even with these measures, a respondent wanted a second
confirmation regarding the identity of the person who made the referral suggested that
respondents could be very sensitive to receiving unsolicited surveys. This perception
seemed supported by results from a survey conducted by Silverpop titled “Spam: What
consumers think” showing that 76% of the respondents said that the messages which they
reported as spam were simply those they “felt” they had never registered to receive
(Silverpop, 2009). The response rate in this study of about 75% is high relative to many
other electronic surveys of this type (Penwarden, 2014; Sheehan, 2001) and may reflect
the high level of interest that industry may have to ensure their views are heard.
Most respondents were employed by relatively large companies, even though no attempt
was made to narrow the survey population to only large companies. There could be
several reasons for the overrepresentation of large companies. Small companies may not
use social media extensively, may not make products with consumer-facing features, or
may outsource so much of that activity that they do not feel they could participate
adequately. Small companies will also have few employees with the expertise to
participate, and those who could participate may be overly busy or less likely to see value
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or take time for such an activity. The fact that about two-thirds of the respondents were
involved with devices was expected given that a particular effort was made to ensure a
good representation of medical device respondents. The focus on the medical products
sector was felt to be important in order to permit an in-depth analysis of issues related to
a specific industry sector. However, such focus will limit the value of the survey in
reflecting views on the ways that social media impacts promotion and advertising across
other sectors, such as foods or dietary supplements, and may mask differences in
subpopulations, such as device versus pharmaceutical sectors. No obvious differences
were seen when cross-tabulations were carried out relative to product category.
However, small differences in subgroups cannot be detected with small sample sizes.
Better differentiation of views of subgroups, if they exist, will only become apparent
when these subgroups are deliberately analyzed in future studies.
5.2.2 The Survey as a Research Tool
An additional methodological element that should be considered is the potential
limitation of the survey as an appropriate research tool. The use of online self-
administered surveys has become very popular over the last decade, in part because of the
simpler methods to reach potential respondents electronically and the facile analytic
capabilities of the statistical programs embedded in the software (Qualtrics, 2014).
Nevertheless, email surveys have many of the same limitations as other survey types.
When using such a tool, it is important to safeguard against potential bias and to
encourage honest answers, for example by limiting direct interaction with the respondents
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in ways that might affect their answers to survey questions (Evans & Mathur, 2005).
Individuals asked about their views on job-related initiatives and practices may have
concerns that their identities will be disclosed and thus may not be forthcoming in their
answers to questions (Cho & Larose, 1999). Although the survey questions were
structured to safeguard respondent privacy, respondents may consider any possibility that
they might disclose company confidential or sensitive information as too risky or
unethical. Thus, text placed at the beginning of the survey was used to reassure the
respondent of the anonymity of the responses and questions were structured in a way that
avoided putting the respondent in a position that required disclosure of confidential
information, activities or strategies. The fact that most participants appeared to answer
all of the questions suggested that most of the participants were comfortable with
participation.
A final concern throughout the survey deployment period was the possibility that
contemporaneous changes in the regulatory environment might have an impact on study
results. Views of respondents may change, for example, when new regulations or
guidance is introduced. Of potential relevance, then, were three FDA draft guidance
documents released for comments, one immediately prior to the deployment of the survey
(FDA, 2014c) and two during the period of survey deployment (FDA, 2014d, 2014e).
Questions related to the first draft guidance were incorporated in the survey, but of
concern was the potential impact of the latter two draft guidances. Fortunately, these
concerns appeared unjustified after a review of the guidances showed that they aligned
closely with what was already discussed in the 2009 FDA Hearing described in chapter 2,
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and were unlikely to change what was already considered to be the current regulatory
environment. There is no doubt that the DTC environment with respect to social media
will continue to evolve, however, the results collected here can serve as a benchmark
against future research that captures many of the views of the industry as of 2015.
5.2.3 Validity of Survey Questions
The validity of a survey depends on how well the survey can in fact measure what it set
out to measure. In this research study, concerns about internal validity were addressed
through the use of a focus group with experienced professionals from different fields and
academic backgrounds to critique and make recommendations on the questions in the
survey instrument. Consultation with independent reviewers who have knowledge of the
subject matter is a good way to improve the survey and minimize bias (Marshall &
Rossman, 2011). Historically, focus groups were used as group interviews to provide
information as part of marketing research (e.g., interviews) dating back to the 1920s
(Basch, 1987). More recently, they have been used extensively in various fields of
research and development, for example to give feedback on product designs (Bruseberg
& McDonagh-Philp, 2002), as well as in social science settings, to explore the views of
particular subgroups, such as sensitive subpopulations whose responses would be
difficult to secure by other means (Marshall & Rossman, 2011). The use of focus group
members as consultants to critique a survey instrument rather than as respondents to
provide experimental data is unusual. However, it has been viewed by others as an
effective approach to ensure internal validity in recent regulatory science and social
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studies, (Jamieson, 2011; Ramsey, 2013) and to control the bias that I might introduce
because I work in the review and approval of promotional materials and policy
development in my professional capacity. Thus, I may have my own recognized or
unrecognized views that could creep into the survey, a well-known limitation of such
social science studies (Crux, 2013).
The survey employed a mix of multiple-choice and scaled question formats which
allowed some measure of quantification. Additionally, open-ended questions requesting
text-box entries as well as open-ended “other” categories were employed. The open-
ended questions helped respondents to answer certain questions in more detail or provide
clarity on views that might not be well captured by simple multiple-choice options.
However, these had the potential to increase survey length. A concern that has been
emphasized previously with respect to the logistics of survey implementation has been
the need to limit survey length. It is conventional belief that the longer the survey
questionnaire, the less likely people will respond or will provide less thoughtful answers,
reducing data quality (Selm & Jankowski, 2006). This assumption is not accepted by all.
Herzog and Bachman have argued in a study of long and short questionnaires directed at
high school students that the length of the survey had little effect on the quality of
responses (Herzog & Bachman, 1981). Further, in an article titled Respondent Burden,
Bradburn further argued that respondents are likely to tolerate longer surveys that address
issues of importance or interest to them (Bradburn, 1978).
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This consideration seemed particularly important for the present work, because
respondents were professionals who might normally not be able or willing to devote the
time needed to complete a long survey. Nevertheless, the issues surrounding the use of
social media are relevant to the job responsibilities of these respondents, and this may
have contributed to their willingness to complete the entire survey.
5.3 Current Status of Promotion through Social Media
The results of the present survey provide a snapshot of current practices related to the use
of social media for the promotion of medical products. It suggests that the use of web
media and social media is already well entrenched, at rates beyond that of conventional
media such as television and print channels. This shift appears in part due to the cost-
effectiveness, reach and flexibility of online advertising and the ability to target specific
demographics in ways not possible with traditional media types (GBIResearch, 2012).
The use of social media also appears to be growing at a pace reflecting the growth in the
internet sector in general, fuelled by the increasing flexibility of smartphone technology,
personal computing capabilities, application downloads and internet use in general.
These trends seem also link to a growing desire and expectation of consumers that health
information will be available and shared extensively (Aitken et al., 2014). Although both
social media and traditional media can have a global reach, traditional media generally
addresses a much more limited audience. With plenty of free hosting sites, social media
has the potential for wide distribution with little to no cost of use. Further, its messages
can be read and shared throughout the day instantaneously as compared to the messages
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of traditional media that take much time to produce and then to air or publish. Even then,
they can often only be seen or heard at specific times.
The avenues by which information can be obtained through the internet are changing
with the changing capabilities of the available platforms. Facebook was seen in this
study to be the most popular social media channel. However, microblogs (e.g., Twitter)
and Youtube were not far behind. The fact that many more “votes” than respondents
were given when the use of all sites was considered in aggregate suggests that many
companies are using more than one social media channel. Respondents tended to
emphasize that “building brand awareness” was a more important driver than “increasing
sales”. It would, therefore make sense to use multiple social media channels to assure the
widest possible reach.
It is not surprising that tools like Facebook ranked highly as a means to provide product
and service information. Its immediacy allows a company to educate or correct
misinformation that could deceive a reasonable consumer. The fact that it is seen to be
less useful as a sales tool may reflect a sense that these uncontrolled dynamic channels
are less suited to sales activities. Further, certain recent research suggests that associating
a medical condition with a branded product can in fact be counterproductive. In social
media culture, conversations related to medical conditions seem typically “unbranded” in
the sense that no specific product name is mentioned. Consumer comments tend to be
more negative when brands are discussed explicitly (Bulik, 2011).
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Facebook is a particularly popular social networking service that provides access to
visitors and allows those visitors to add information to the company’s postings at any
time, through user-created profiles and collections of ”friends”. A key feature is the
ability for users to “like” the posting; these votes of support are prominently reflected on
a company’s official Facebook page (GBIResearch, 2012). At the same time, these
sharing features can be problematic for the companies if they do not use Facebook sites
carefully. For example, a recent warning letter in June 27, 2014 to Zarbee, a Utah based
dietary supplements company, was prompted by the fact that the company “liked” the
following comments made by a consumer on Facebook:
…Children’s Sleep remedy…I received the free sample…and…gave it to my
daughter…I could not believe how well it worked! She was recently diagnosed
with ADHD and put on medication…causing insomnia…
The vote of approval by Zarbee was interpreted by FDA as a type of endorsement/
promotion for off-label use (FDA, 2014i).
Twitter, currently the most popular microblog, is a social media site where users can
tweet messages of up to 140 characters to others using a common “hashtags” that sort and
direct the entries. Microblogs often knit together passionate communities based around a
set of shared interests. Some companies use twitter to provide constant stream of news,
while others use it as a customer service platform to provide support for customers
seeking help (Miletsky, Bough, & Agresta, 2010). Twitter is appealing for companies
because it has the advantage of reaching its users in real-time and its unusually facile
capability to broaden the audience when the information is retweeted by consumers
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(Morel, 2012). However, these platforms require long-term investment because content
must be refreshed and monitored continuously to engage the audience (Bashash, 2013).
An interesting avenue of future research might be to understand logistically how
companies are managing such blogs because they require such constant attention.
Microblogs such as Twitter have come under much regulatory scrutiny and also been
targets for warning letters from the FDA. For example, in the same warning letter to
Zarbee as referenced above, FDA criticized promotional claims made through tweets that
advocated the use of this product for cold and cough relief (FDA, 2014i). Industry has
been particularly concerned about the way that promotional messages in microblogs can
be used because message lengths are so limited. This confusion and concern has led
FDA to publish its very recent guidance document, titled, Draft Guidance for Industry on
Internet/Social media Platforms with Character Space Limitations-Presenting Risk and
Benefit Information for Prescription Drugs and medical devices (FDA, 2014d). This
guidance identifies that promotional information must incorporate an adequate balance of
risk-to-benefit information within the same “tweet” regardless of character space
limitations. If benefit and risk information cannot be communicated together, FDA
recommends that the user should reconsider the microblog as an appropriate
communication tool. Additionally, FDA recommends that a mechanism to a more
complete discussion on risks be provided to direct consumers, usually by referral to a
website. It is this position that seems to have been most contentious of all of the issues
identified in the present survey.

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The new guidance has also had mixed reviews by industry and other stakeholders. For
example, the Biotechnology Industry Organization (BIO) argues that the guidance is not
sufficiently flexible, and imposes a stricter standard inconsistent with the FD&C Act. Its
restrictions had already been criticized prior to the release of the guidance for failing to
recognize the challenges of providing risk information in such a short space, especially
when that information is relatively complex (Dickinson, 2014).
BIO proposed the following as an alternative consistent with the survey response:
We suggest as an alternative approach that FDA revise the
“requirements” of the Draft Guidance to be recommendations where
feasible, but be flexible in allowing even more concise summaries when
“all serious risks” and benefits would exceed the character- space-
limitation. In such an approach, Sponsors can effectively make a truthful
and non-misleading statement in a character space-constrained digital
platform using a more concise summary of benefit and safety information,
as long as they include clear and conspicuous links to where the
additional, more detailed information can be found (Peters, 2014).

This approach appeared to be the one preferred by more respondents here. The views of
the respondents also appeared to concur with that of the pharmaceutical trade group
PhRMA as discussed in the Public Hearing on Promotion of FDA Regulated Medical
Products Using the Internet and Social Media Tools (FDA, 2009d). PhRMA and also
commented further that the FDA’s draft guidance “is inconsistent with the agency’s own
practice of communications about medicines using Internet and social media platforms
with character space limitations” (Gaffney, 2014). The WLF echoed BIO’s sentiments
and further argued that the definitions of “labeling” and “advertising” in the guidance are
overly broad and inconsistent with FDA’s statutory mandate; it charged that FDA lacks
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the statutory authority to regulate many of the manufacturers’ statements that the draft
guidance seeks to regulate (Samp & Andrews, 2014).
YouTube, a multimedia channel that includes videos, photos, images and audio files, is
another cost-effective avenue for product promotion. Companies should take precaution
when using YouTube to obtain the permission of any participants who might be
considered as company “representatives”, or to be cautious when hosting sites where
consumers discuss their experiences with medical products or treatments. Such
messaging sometimes leads to discussions of off-label use, in which industry cannot
participate actively without committing the offense of misbranding. For example, in
Sept. 2008, FDA sent a warning letter to Shire about a YouTube video featuring TV star
Ty Pennington who discussed his use of Adderall to treat his ADHD. The FDA stated
that the video contained quality-of-life and other claims for which insufficient data
existed (FDA, 2008d). The results of this study suggesting that social media is preferred
to educate consumers about diseases rather than products, may relate to the differing
standards that FDA applies to “disease state” communications. To be viewed as a
“disease state” awareness communication, the piece must not be branded but separated
from other branded materials. Such communications are then not regulated by the FDA as
labeling (FDA, 2004).
Even though social media may be used most commonly to promote awareness, it is
apparent from responses here that the channels are also being used for many other
purposes. The least common of those purposes presently appear related to patient
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support, either in terms of providing treatment reminders or reimbursement information.
These low rankings are somewhat surprising given the literature on the use of social
media in the pharmaceutical sector, where treatment reminders and reimbursement
information are seen to be useful (NHS, 2014). However, when patients use drugs on a
regular basis, compliance becomes a critical issue for a successful outcome. Devices
play by different rules. Once a patient acquires a device, especially an implanted device,
the need to replace or service that device is often minimal. Further, the rules for
reimbursement differ. Currently most devices are reimbursed as part of a bundled
payment for a health-care episode of care called a diagnosis-related group (DRG), and the
cost is billed to the hospital rather than the patient. However, in future, the cost sharing
formula may change. Increasingly, individuals (as opposed to employers) purchase
insurance coverage for themselves or their families through the creation of exchanges or
the use of Medicare plans offered by private payers as an alternative to traditional fee-for-
service Medicare models (Chilukuri, Rosenberg, & Kuiken, 2014). Additionally, patients
are demanding more information and decision-making control over the devices that they
receive, and may opt to pay a premium for a more expensive product not covered
completely by their insurance plan. This may push payers and other stakeholders to
participate in social network sessions in which information on use and reimbursement is
shared with patients who might be conducting research on disease states and treatment
options. Chilukuri, Rosenberg and Kuiken reported that:
greater access to data is already driving changes in care protocols,
allowing the benchmarking of physicians, aiding the identification of
clinical best practices, informing the adjustment of benefits and
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reimbursement structures, and resulting in actual behavioral change
(Chilukuri et al., 2014).
5.4 Do Current Regulations Achieve the Aims of Regulation?
The research presented here was undertaken to identify whether DTC regulations
accomplish the roles that society expects regulations to play: to assure safety and
efficacy of products, to assure a level playing field amongst companies of different sizes
and types, to foster efficiencies in the path to market, and to provide a uniform
benchmark for compliance amongst different companies. Thus, questions regarding each
issue were posed, and responses can be examined in the light of this framework.
5.4.1 Do the regulations heighten safety?
Perhaps the most important goal perceived by most for medical product regulation has
been to protect the public from unsafe or ineffective products (FDA, 2012a).
Promotional regulations attempt to heighten public safety by preventing the improper
product use that might occur if the consumer were to have an insufficient understanding
of benefits and risks (Spence, 1977). However, only a minority of respondents (8 of 45)
appeared to feel that the regulations were effective in enhancing product safety, and more
felt that the restrictions on information exchange actually made product use less safe.
Furthermore, the largest group of respondents indicated ambivalence or uncertainty about
the usefulness of the regulations with regard to safety. What remains unclear and may
benefit from further exploration in future is whether these individuals express a neutral
opinion because they feel that insufficient information is available to make a judgment
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currently, or that the promotional rules do not have a significant ability to affect patient
safety no matter what they require or limit. However, at least in the views of respondents
here, there does not seem to be a consensus on whether the regulations are really effective
in achieving safety-related goals.
It is worth to note that the US already has had liberal regulations regarding DTC
advertising compared to most other countries where DTC advertising is prohibited. As
such, the only regulatory system for DTC advertising with which the new US guidance
documents can be compared is to that of New Zealand. New Zealand is the least
regulated system and permits a higher degree of self-regulation; this approach appears to
be more attractive to many respondents who appeared to view certain US FDA
requirements (such as the demanding reporting requirements and the limitations on the
use of messages with constrained word lengths) to be unduly constraining. Views of
physicians in New Zealand also tend to suggest broad-based approval of the New
Zealand approach. Both the New Zealand Medical Association and the Royal College of
New Zealand General Practitioners felt that freer communication was able to provide
important medical information to patients with little apparent harm (Hoek & Gendall,
2002a, 2002b). This essential because the New Zealand experience departs so strongly
from both the American system and that in Europe and other developed nations. It raises
the question of whether the “protections” imposed by tightly regulated pharmaceutical
information regimes that are costly to implement may be needed to protect public health.
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Perhaps the most contentious areas of promotional regulation relate to channels that
restrict message length. The majority of respondents in this survey felt the best way to
provide balanced risk/benefit information about medical products is to “provide the user
with the weblink that directs the user to the complete risk/benefit statement’ or “include
summary of risk/benefits” rather than attempting to include the information in a tweet.
This choice is not in keeping with the most recent guidance for FDA that says:
regardless of character space constraints that may be present on certain
Internet/social media platforms, if a firm chooses to make a product
benefit claim, the firm should also incorporate risk information within the
same character-space-limited communication. The firm should also
provide a mechanism to allow direct access to a more complete discussion
of the risks associated with its product.

These FDA instructions seem to indicate a concern that the character limitations of social
media platforms will prevent valuable information from reaching consumers. Many
respondents in this study may also be signaling some level of agreement with this
concern, by identifying that more static internet options such as the FDA website and the
company’s website are the channels best suited for disseminating product safety
information and for serving as a primary source of risk information.
The usefulness of social media channels for giving consumers reliable information about
product safety typically scored lower. This may relate to the previously discussed fact
that information flow amongst consumers, as opposed to companies, is not restricted, so
erroneous information about products can easily be exchanged (Chou, Hunt, Beckjord,
Moser, & Hesse, 2009). However, consumer blogs did score highly as channels for
timely information about safety, as might be expected of a medium in which news stories
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or problems can easily “go viral”. Despite this capability, blogs still ranked lower than
company websites, suggesting that respondents have a high degree of trust that
companies will quickly provide information about safety problems on their own websites.
Whether this trust is justified remains to be explored, because companies can face
conflict of interest issues as it is not always easy to provide information about safety
concerns when that information has the potential to compromise the commercial success
of their product (Griffiths, Christensen, & Evans, 2002).
5.4.2 Do the Regulations Level the Playing Field?
Poorly constructed or enforced regulations have the potential to damage the industry by
creating a skewed playing field for different participants. As stated by Margaret
Hamburg, Commissioner of the U.S. Food and Drug Administration:
Enforcement helps industry too – by maintaining a level playing field for
safe products. Making sure that offenders are held legally accountable
prevents companies from having to choose between doing the right thing
and staying competitive (Hamburg, 2009).

The importance of assuring that the regulations do not become economically punitive to
smaller companies has been acknowledged and reinforced by the Regulatory Flexibility
Act (RFA), which requires policy makers to consider the needs of small business and
other small entities when new regulations are written (Dixon, Gates, Kapur, Seabury, &
Talley, 2006; Holman, 2005; Pineles, 1997). It is apparent that industry is also sensitive
to the effect of regulations on different players, for example, in results of previous
interviews conducted by Seiguer and Smith. Interviewees stressed that established or
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proposed regulations should be consistently applied across the industry (Seiguer & Smith,
2005).
While economic concerns are often considered more problematic for small companies,
enforcement concerns are typically perceived to be more challenging for larger
companies, seen as preferential targets for regulatory enforcement because of their larger
product portfolios (Dixon et al., 2006; Maloy, 2013; Willing, 2001). For regulators, a
highly visible enforcement action against a large company may be seen as an opportunity
to give a salutary lesson to other companies who might be contemplating a similar
violative action (Boiani & Amy, 2014). The perception that large companies are
preferentially targeted appears to be shared by most respondents in this study. However,
a small number of respondents disagreed and a significant number neither agreed nor
disagreed that larger companies were disproportionately targeted. It is not clear whether
these contrary opinions reflected their professional experiences or whether they had other
reasons for this view. It is however, possible that they are sensitive to recent changes in
enforcement that have been identified by Boiani and Dow, who noted that enforcement
actions related to violative promotions were less frequent in 2013 and were focused
preferentially on smaller companies (Boiani & Amy, 2014).
It is difficult to estimate the relative vigor with which companies of different sizes are
subjected to inspections and enforcement actions from warning letter statistics such as
those above. Large companies tend to be more risk averse than smaller companies
because the consequences of non-compliance can be more punitive for those with deeper
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pockets. Penalties can include large financial fines or delays in marketing approvals, and
losses in the valuation or reputation of the company. Increased FDA regulations and
litigations are also known to have a negative impact on stock price and ultimately
company valuation (Dowdell, Govindaraj, & Jain, 1992). Consequently, it would not be
surprising if the number of inspections and issued warning letters differed from large to
small companies.
5.4.3 Do regulations slow access or reduce competitiveness?
Another key tenet of “good” regulation is to facilitate access to new products and to
enhance efficiencies in their development and commercialization. Research suggests that
DTC advertising can improve access by providing valuable information to consumers
(Calfee, 2002). The use of social media is highly influential in changing the dynamics of
DTC reach, by improving consumer outreach at an affordable price. These advantages are
clearly identified by respondents, with phrases such as, “low start-up costs”, “cost
efficiency”, and “faster and cheaper”. Not surprising then is the finding that most
respondents predict an increase in spending on social media over the next 3 years. These
advantages seem consistent with reports of rapidly increasing use in other sectors such as
consumer packaged goods, consumer financial services, professional services and
advanced manufacturing (Chui, 2013).
The question that might be asked here, however, is whether the ability to use social media
as a way to reduce marketing costs is diminished by the current regulations. The answer
remains ambiguous; even with the current limitations on such activities; respondents still
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seem to feel that increased future investments would be made by their companies. From
previous comments of industry trade groups, it was anticipated that companies might
react negatively to the strict requirements that the new guidances impose. However, in
this survey, most respondents did not seem to express strongly negative sentiments. Most
respondents felt that the guidance clarifies how to interact with social media, was aligned
appropriately with the rules for conventional media, and would not greatly impact
promotional activities. It remains to be seen if this moderate opinion holds in the future.
More experience is necessary to estimate the costs of developing and monitoring
materials and conversations in ways that comply with US social media regulations.
Perhaps the question that came closest to gaining some insight was asking about whether
more resources would be needed to comply with the guidance and whether the guidance
will make social media interactions more difficult than they were before. The fact that
most who could answer the question agreed that more resources would be needed and
activities would be more difficult, seems to argue that the regulations will decrease
efficiency by increasing costs, and these costs will necessarily tend to increase the
ultimate price of the product.
It is important to recognize that the various objectives of regulation cannot always be
viewed as separated elements. For instance, a company that “paints outside of the lines”
can gain marketing advantages in the short term but compromise patient safety and
ultimately disadvantage the company in the long term. It seemed clear from the
respondents here that companies watch each other closely and even intervene when they
see activities that affect competitiveness, by communicating formally with a competitor,
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reporting violations to the FDA or even sending a “cease and desist “letter to a
noncompliant competitor. Perhaps, industry understands that the FDA will probably not
use their limited resources to chase companies over promotional and advertising issues
that have little effect on public safety. Bringing the issue to the attention of the
competitors either by an informal communication or even a cease and desist letter may
then be the most effective pathway to reign in a violative competitor.
5.4.4 Compliance
Another important role of regulation is its ability to set a benchmark that can be enforced
through reviews and audits to assure that companies comply with a common set of rules.
Results here would suggest that companies are generally comfortable to work within the
constraints of the current regulations, if such an interpretation can be drawn from the fact
that they predict growing rather than shrinking participation in social media. That is not
to say that the regulations are not relevant to the decisions to expand the use of social
media. In fact, regulatory compliance risk was ranked as the most important of the
challenges viewed by the respondents in their plans to use the medium.
Companies seem well aware of the evolving regulations. Most respondents reported that
their companies had procedures governing the use of social media consistent with
regulatory expectations. Further, they identified that they have formalized procedures to
mitigate the regulatory risks. Current industry best practices with respect to social media
would include such elements as: establishing a crisis management process; monitoring
promotional activities and policing for off-label promotion; establishing standards for
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testimonial or endorsements, press releases, third party promotions, scientific and
educational activities; reviewing and adhering to the most recent social media guidelines
with a mechanism for approval qualified personnel such as medical, legal and regulatory;
and conducting risk/benefit analyses that take into account the purpose and business
objectives of the project (Culp, Gomes, & Narveson, 2014; Silvis, 2014).
The survey results showed that regulatory and commercial operations/marketing typically
work together to develop an integrated approach to social media. This finding may not
be surprising given that promotional materials are commonly developed or sourced by
commercial operations, and then reviewed by regulatory staff to ensure compliance with
the regulations. These procedures and communications are typically seen as important
because violations may (and sometimes do) result in significant enforcement actions such
as warning letters, product recalls, product seizures, civil and criminal penalties that have
serious business, legal and regulatory repercussions. The adverse publicity can damage
company reputation and diminish company value to investors and customers.
Nevertheless, the risk seems relatively manageable if the company makes an effort to
comply. The majority of respondents reported that no enforcement action related to the
use of social media has been issued to their company. More so, fear of enforcement
action did not rank highly as a risk identified by the respondents. This is perhaps not
surprising as the numbers of enforcement activities that reach a high level of seriousness
is relatively small to date. A survey of 2013 enforcement letters available as of January
23, 2014, showed that the FDA issued 26 enforcement letters that together identified 38
promotional pieces for drug and biological products as inappropriate; only 4 (15%) of
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these letters were warning letters, the remainder were “notice of violations” letters,
sometimes called “Untitled Letters”. Further, OPDP issued an even lower number of
enforcement letters, only 10, in 2014 (Senak, 2015). The falling number of recent
warning letters is not an anomaly, but rather reflects a trend. Over the last several years,
the relative proportion of warning letters has been dropping steadily. In 2008, 48% of
OPDP’s enforcement letters were untitled letters. In 2009, 68% were untitled letters; in
2010, 77% were untitled letters; in 2011, 84% were untitled letters and in 2013, 85%
were untitled letters (Covington, 2013; Hunton & Williams, 2014). Additionally, the
number of internet-based violations decreased from 39% in 2012, to 18% in 2013. Of the
10 enforcement letters issued in 2014, only three were related to the internet (FDA,
2014h). It is uncertain whether this drop in enforcement activity reflects better behavior
on the part of companies, delays in enforcement pending the publication of promised
guidance materials, or a diminution of resource allocation to such enforcement activities.
Concurrently, some amount of remodeling of enforcement approaches seems to be
occurring. Despite the perceived risk with social media use, regulatory enforcement
patterns indicate that traditional media have garnered more enforcement actions from the
FDA than have digital media in the past (Senak, 2013). This trend seems counterintuitive
and may reflect historical resource allocations biased toward the oversight of traditional
media. The FDA has recently proposed to increase its allocation of inspectional resources
toward the oversight of social media, and the effect of such a shift on FDA actions will be
interesting to observe (FDA, 2014b).
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Other entities involved in regulation and guidance related to social media promotion
include: state law enforcement agencies, public interest organizations, such as the
National Advertising Division (NAD) of the Council of Better Business Bureaus and
professional associations, such as the American Medical Association. Responses in this
survey suggested that not one agency stood out as the agency of preference to oversee
and enforce promotion in social media. The split in preference between FDA and FTC
was interesting, and the reasons for choosing one or the other entity remain vague. In
retrospect, it would have been helpful to have explored the reasons for these choices, and
in future, this would be an interesting direction for further research.
Equally interesting was the suggestion from a minority of respondents that advertising
and promotion should be self-governed by the industry. A model for such self-
government might be that in New Zealand where DTC activities are regulated by the
Advertising Standards Authority, a self-regulated body (Hoek & Gendall, 2002b).
However, this question of preference is possibly an academic argument. The likelihood
that the arrangements for “ownership” of the oversight activities would change is
probably very low because such change would require new legislation. Further, some
might argue that such change might be unnecessary as the FDA and FTC already have a
shared approach with respect to enforcement oversight. The complementary roles are
evident, for example, in a joint FDA/FTC “Untitled letter” issued in February 2013, in
the form of an email to online distributors of decorative contact lenses for promoting their
products without a valid prescription. The FDA asserted that the products were
adulterated or misbranded because they were unapproved, and simultaneously, the FTC
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identified that the sale without a valid prescription violated the Fairness to Contact Lens
Consumer Act, and the Contact Lens Rule. The letter threatened a possible criminal
action. However, differences exist between the approaches of the two agencies; the
standards enforced by the FDA for prescription products tend to be stricter. The term
misbranding under the FDA is easier to assert in that the FD&C Act only requires
labeling to be “false or misleading in any particular,” while the FTC must show that the
misleading statement is “materially misleading”. These differences were underlined in a
provocative statement by Nicole Gerhart:
The FDA holds labeling to a higher standard than the FTC, for the FDA
attempts to protect the ignorant, the unthinking and the credulous from
being misled, while the FTC, under its enforcement policy, will only
protect the consumers who are acting reasonably under the circumstances.
(Gerhart, 2002)

One thorny issue not directly related to promotional activities though evident when
evaluating the use of social media, is that of monitoring adverse events that might be
reported by patients on social media sites. Typically, a company is required to report all
adverse events brought to their attention to the FDA. However, social media reports are
difficult to interpret and investigate. For instance, screen names commonly do not
provide a way to contact/identify the originator of the message, thus making it difficult to
identify an “identifiable reporter” or “identifiable patient”. To encourage the most
effective AE reporting to FDA, FDA has been encouraged to develop a user-friendly
system through which web users may report events directly to FDA (as suggested by
167
speakers at the November 12-13, 2009 Part 15 hearing on this topic; See Chapter 2, page
68).
This challenge of monitoring adverse events on social media sites expands beyond the
US. In the European Union, marketing authorization holders must also report suspected
serious adverse reactions of which they might reasonably be expected to know. Most of
the guidance for reporting activities takes its lead from drug regulations and drug industry
practices. In that respect, it has been clearly stated that, at minimum, a company has an
obligation to monitor any digital media that it sponsors should that site solicit information
from patients about medicines they are taking and any adverse drug reactions they suffer
(EMA, 2012). Appropriate provisions should be included in any terms of use, privacy
policy, and/or registration procedure to address the fact that additional information to
make a complete report may be needed from a site member or participant (ABPI, 2013).
Most respondents in this study felt it is possible to monitor social media for adverse
events, although only a few appeared to feel it as reasonable or desirable to do so.
Some respondents expressed the view that the overall impact of the FDA guidance on
“Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive
Promotional Media for Prescriptive Human and Animal Drugs and Biologics” did not
greatly change the regulatory risk of participating in social media compared to
approaches prior to guidance issuance. It will be interesting to ascertain if those views
will change after experience is gained with the two draft guidances issued in the last six
months. These documents are identified as useful, yet challenges and practical limitations
168
still exist. For example, the guidance does not comment on the way that product images
and videos depicting product claims, features or benefits should be included in social
media sites. However, electronic/digital platforms associated with character space
limitations, such as microblog messaging and online paid search, are capable of
uploading product images and video depicting product claims, features or benefits
without the need for additional text. For instance, manufacturers may choose to create a
video depicting the product claims, features or benefits and post it on Twitter without any
characters. Therefore, the character constraints do not apply in this situation and guidance
does not address whether a pictorial approach would be appropriate or adequate.
Similar results were observed in a survey conducted by Tufts Center for the Study of
Drug Development (Tufts) directed at pharmaceutical industry using social media in
clinical research. Tufts gathered the data by reviewing 17 pharmaceutical and
biotechnology companies and three contract research organizations, to assess current and
anticipated use of social and digital media communities in clinical research in
predominantly North American investigative sites. According to the study, the companies
reported using social media for patient recruitment on an estimated 11% of all clinical
trials, but expressed concerns with potential violation of patient privacy. Similar
concerns such as the need to invest substantial time and resource on adverse event
reporting were also identified in the use of social media. That survey, like to one
reported here, seemed to confirm that Facebook is the most common channel to be used
in product promotion and patient recruitment. Other findings were similar as well, such
169
as the use of social media to distribute information about products and to promote disease
awareness (Lamberti et al., 2014; Taylor, 2014).
5.5 Future Research and Conclusion
The survey results collected here provide insight into the medical product industry’s view
of DTC using social media. The increased social media spending projected for the next
few years has created unique regulatory challenges. The new guidances developed by
FDA for social media platforms attempt to align the rules for DTC promotion with older
rules for print and broadcast media. These guidances should be helpful as they provide
added confidence in the rules and interpretations to be expected from the FDA, thus
avoiding unpredictable enforcement practices (Oster & Quigley, 1977). However,
several uncertainties about the impact of the regulations going forward still seem to exist.
Further, the interactivity and reach of social media may make the attempt to regulate
social media with the same types of rules used for traditional media in the 90s more
tenuous over time. Thus, it remains imperative that FDA monitor carefully the
usefulness of its approaches and open-minded about other potential opportunities to
reduce regulatory hurdles when they are not providing a useful purpose.
The FDA has recently commissioned surveys to gain insight into views of some
stakeholders, particularly physicians, regarding its DTC advertising policy (FDA,
2014g). This level of self-assessment is rare among regulatory agencies but is consistent
with a recent governmental call for more transparency and attentiveness to customer
needs (Croley, 2011; Obama, 2009). One project was designed to test the different ways
170
of presenting prescription drug risk and benefit information on branded drug websites.
This research was similar to the study conducted by the FDA in 2002, on physician
attitudes towards DTC. Only, in this new study they (1) included a wider range of
prescribers, such as nurse practitioners and physician assistants; (2) balanced the sample
to obtain representative opinions from the fuller range of healthcare professionals; and (3)
asked a wider variety of questions about both DTC and professional promotion of
prescription drugs. The study also examined awareness of FDA’s Bad Ad program and
healthcare professionals’ use of social media (Ruper et al., 2014). The Bad Ad Program is
an FDA-sponsored outreach program designed to educate health care professionals about
the role they can play in helping FDA ensure that prescription drug advertising and
promotion is truthful and not misleading.
Social media presents a new and greater challenge to the FDA than the introduction of
television and DTC advertising due to the interactive and pervasive nature of social
media, the role of third parties to provide information of all types and the ability to
transfer and modify content without the permission or even knowledge of the initiator. As
new channels surface and current ones continue to evolve, the manner in which the FDA
will treat this new mode of promotion and advertising remains nebulous. The very
strengths of social media tend to be ignored in favor of a continued focus on all media as
if the messages were simply broadcast, without recognizing the challenges introduced
when the audience talks back, or to amplify or distort the messages in conversations that
soon cease to include the company. How will the FDA regulate the continued
conversations, once the first information has been sent?
171
One area not covered by this research is the way that information should be provided on a
channel in which participants may have low health literacy or numeracy. This is a
pertinent topic because much of industry’s success in business depends on their ability to
communicate with consumers effectively. Further, the fact that consumers are seeking
their information online suggests value in facilitating educational materials (Stolberg,
2000) to help consumers to identify the potential presence of underdiagnosed and
undertreated diseases such as depression, diabetes AIDS and osteoporosis (Allen, 1999; J.
E. Calfee, 2002; Glick, Suppes, DeBattista, Hu, & Marder, 2001; Leape, 1995). Also
missing from the literature is information on the cost of participating in certain types of
social media activities, and the relative level of reach and impact that those activities
produce. It is not premature to put quantitative research plans in place, in an order that
metrics can be considered and data can be gathered.
This research shows that companies are and will increasingly use social media to give
timely and reliable information about medical products, but concerns remain about
compliance with existing rules. The views identify strong advantages to participating in
social media, but also show that companies have a significant concern about the perils of
non-compliance. A regulatory policy, when well designed, should strike a balance
between protecting public health and at the same time enabling market access (Riviere &
Buckley, 2012). The current guidances regarding social media are still in draft form. As
they are evaluated and modified, attention must be directed at striking a difficult but
important balance between protecting the health of the public while preserving the
172
legitimate interests of industry, healthcare providers, consumers, advocacy groups, payers
and patients by encouraging conversations about new treatments and products.
173
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197
APPENDIX A
The following survey seeks to explore the views of US medical products manufacturers
regarding the use of social media. Your views are important for us to understand the
current landscape around the use of social media for advertising and promotion. Thank
you for your time and effort. All of your answers will be anonymous.

198

199

200

201

202

203

204

205

206

207

208

209
APPENDIX B
1. What title is aligned most closely with your current responsibility?

210
# Answer

Response %
1 CEO

0 0%
2
Compliance
Officer

0 0%
3
Vice
President

2 4%
4 Director

18 35%
5 Manager

22 43%
6 Counsel

1 2%
7 Coordinator

1 2%
8
Other (Please
specify)

7 14%
Total

51 100%

211
Other (Please specify)
Senior Regulatory Affairs Specialist
Sr. RA Specialist
Consultant
Specialist
Senior Specialist
Project Manager
Sr. Regulatory Affairs Specialist

212
2. What is your Job Function? Please choose the best answer.

213
# Answer

Response %
1 Regulatory Affairs

25 50%
2
Quality
Assurance/Compliance

2 4%
3
Public
Affairs/Government
Affairs

4 8%
4
Legal
Affairs/Compliance

1 2%
5 Medical Affairs

0 0%
6
Commercial
Operations (Sales &
Marketing)

11 22%
7 Ethics and Compliance

0 0%
8 Strategic Marketing

7 14%
9 Other (Please specify)

0 0%
Total

50 100%
214

Other (Please specify)

3. Which group in your current organization controls social media promotional review and
approval?

215
# Answer

Response %
1 Regulatory Affairs

29 58%
2
Quality
Assurance/Compliance

1 2%
3
Public
Affairs/Government
Affairs

5 10%
4
Legal
Affairs/Compliance

2 4%
5 Medical Affairs

0 0%
6
Commercial
Operations (Sales &
Marketing)

1 2%
7 Ethics and Compliance

0 0%
8 Strategic Marketing

5 10%
9 Other (Please specify)

7 14%
Total

50 100%
216

Other (Please specify)
Regulatory & Legal, Marketing
It is both Public Affairs and Legal, and sometimes RA is consulted
Regulatory Affairs, Legal and Marketing
PA together with marketing
Corporate Communications
team including strategic marketing, PA, regulatory, and legal.
Regulatory Affairs and Legal Affairs

217
4. What is your company's annual revenue (in U.S. $)?

218
# Answer

Response %
1
$ 10 M or
less

1 2%
2
$ 11M -
$100M

0 0%
3
$ 101M - $
500M

6 12%
4
$ 501M - $
1B

6 12%
5 > $ 1B

38 75%
Total

51 100%

219
5. In which product categories are you involved? Please check all that apply.

220
# Answer

Response %
1 Devices

46 90%
2
Prescription
Drugs

8 16%
3
Combination
Products

8 16%
4 Biologics

5 10%
5
Other (Please
specify)

8 16%

221
Other (Please specify)
OTCs
Nutritionals
Data reflects ADD not temp position in AAH.
broad-based health care
Nutrition
Animal health products
OTC Drugs/Cosmetics
Nutrition, vision, vet

222
6. Are your promotional activities outsourced?

# Answer

Response %
1
Wholly
outsourced

1 2%
2
Partially
outsourced

34 67%
3
Not
outsourced

16 31%
Total

51 100%

223

224
7. Other than social media, which media channels do you use for Direct to Consumer
Advertising (DTC)? Please check all that apply.

225
# Answer

Response %
1 Television

30 59%
2 Newspaper

15 29%
3 Magazines

33 65%
4 Radio

13 25%
5 Web media

42 82%
6
We do not
use DTC
Advertising

7 14%
7
Other (Please
specify).

4 8%

226
Other (Please specify).
print media
Postcards/Newsletters
different divisions use different channels
digital and social media

8. What is your level of involvement with regard to promotional activities using social media?
Please check all that apply.

227
# Answer

Response %
1
Recommend
strategy

38 75%
2
Create
content

13 25%
3
Approve
content

31 61%
4
Coordinate
with FDA

6 12%
5
Monitor
compliance

15 29%
6
Participate
online

7 14%
7
Other (Please
specify)

7 14%

228
Other (Please specify)
Not yet
Approve content only if product related
Testing
I don't have any direct level of involvement
Review and approve
Coordinate with Marketing team
Business partner

229
9. If you are using social media, please check all of the channels that apply.

230
# Answer

Response %
1 Facebook

29 73%
2 Youtube

23 58%
3
Microblogs
(e.g. Twitter)

26 65%
4
Discussion
Forums

11 28%
5 Blogs

18 45%
6
Other (Please
Specify)

8 20%

231
Other (Please Specify)
Internal organizational promotion of products that employees can use to market
products with customers and family. Also used internally to promote products to
employees at a discount.
Not yet
Twitter
N/A
LinkedIn
Twitter, Vine, Instagram, Pinterest
through Abbott Corporate channels only
Instagram

232
10. Does your company use or plan to use social media in the following areas to engage
customers?

233
# Question Present Planned Total Responses
1
Provide
discounts/coupons
15 8 23
2
Provide customer
service
information
20 16 36
3
Provide treatment
reminders
5 3 8
4
Provide support
group
opportunities
12 11 23
5
Provide
education/games
to promote
healthy behavior
16 13 29
6
Provide education
to recognize
disease states
17 13 30
234
7
Provide product
information
27 20 47
8
Provide
reimbursement
information
11 5 16
9
Gather customer
experience
20 16 36
10
Solicit customer
feedback
19 13 32

235
11. What core objectives does your company consider when deciding to proceed with social
media promotion. Please rank with most preferred item on the top).
# Answer 1 2 3 4 5 6 7 8
Total
Responses
1
Build
awareness
or generate
interest
30 7 3 5 0 1 1 0 47
2
Increase
product
adoption
3 10 11 10 9 4 0 0 47
3
Grow and
maintain
consumer
relationships
3 11 5 8 9 9 2 0 47
4
Influence
customer
perception
3 8 13 10 6 6 1 0 47
5
Risk and
reputation
3 5 5 8 12 12 2 0 47
236
(protect,
defend and
enhance
brand)
6
Increase
sales
4 6 9 5 7 11 5 0 47
7
Reduce
attrition
0 0 1 1 4 4 36 1 47
8
Other
(Please
Specify)
1 0 0 0 0 0 0 46 47
Total 47 47 47 47 47 47 47 47 -

237
Other (Please Specify)
Responding to recall information, customer inquiries, increase presence in blogs/forums
address competitiors
create online support community
Increase engagement with brand

238
Statistic
Build
awarene
ss or
generat
e
interest
Increas
e
produc
t
adopti
on
Grow and
maintain
consumer
relationshi
ps
Influenc
e
custome
r
percepti
on
Risk and
reputati
on
(protect,
defend
and
enhance
brand)
Increa
se
sales
Reduc
e
attriti
on
Other
(Pleas
e
Specif
y)
Min
Value
1 1 1 1 1 1 3 1
Max
Value
7 6 7 7 7 7 8 8
Mean 1.83 3.51 3.94 3.64 4.38 4.23 6.62 7.85
Variance 2.01 1.99 3.02 2.28 2.68 3.53 0.85 1.04
Standard
Deviatio
n
1.42 1.41 1.74 1.51 1.64 1.88 0.92 1.02
Total
Respons
es
47 47 47 47 47 47 47 47

239
12. In your experience, which statement best describes your company's participation in social
media in the last 2 years?

240
# Answer

Response %
1
Major
increase

21 42%
2
Minor
increase

17 34%
3
Major
decrease

1 2%
4
Minor
decrease

1 2%
5 No change

10 20%
Total

50 100%

241
13. If you chose major increase, what was the reason?

242
# Answer

Response %
1
Exploit cost
efficiency of
social media

3 14%
2
Build brand
awareness

8 38%
3
Overcome
the limited
Interactivity
of traditional
media

5 24%
4 Increase sales

1 5%
5
Other. Please
Specify

4 19%
Total

21 100%

243
Other. Please Specify
Build brand awareness and initiate participation in social media given other competitors'
have a presence in social media
Social Media is more mainstream now, and part of the marketing mix, also there is
global adoption and cost efficiency
building online community
Cost AND leverage the opportunity for heightened engagement

14. If you chose major decrease, what was the reason?

244
# Answer

Response %
1
Resource
constraints
within the
company

0 0%
2
Fear of
enforcement
action

0 0%
3
Lack of clear
guidance

0 0%
4
Concerns
regarding
privacy
protection

0 0%
5
Other (Please
specify)

1 100%
Total

1 100%

245
Other (Please specify)
Lack of guidance from outside regulatory authorities/bodies

246
15. How important are the following challenges with respect to the commercial use of social
media. Please rank the following from most important to least important.
# Answer 1 2 3 4 5 6 7 8 9 10 11
Total
Responses
1
Regulatory
restrictions
on customer
interaction
15 4 8 4 6 3 3 1 0 0 0 44
2
Uncertain
potential of
social media
to create
value
4 5 3 3 4 5 5 6 6 3 0 44
3
Uncertain
return on
investment
2 4 3 2 3 3 6 2 11 8 0 44
4
Regulatory
compliance
risk
9 13 7 5 6 0 2 0 2 0 0 44
5
Insufficient
3 3 4 1 5 6 5 8 3 6 0 44
247
resources
6
Challenges
with
monitoring
1 6 2 11 7 7 4 2 2 2 0 44
7
Fear of
enforcement
actions
2 2 5 4 4 3 8 8 4 4 0 44
8
Loss of
content
control
2 4 7 6 2 9 4 7 3 0 0 44
9
Privacy
concerns
0 0 1 3 5 5 4 6 11 9 0 44
10
Lack of clear
guidance
6 3 4 5 2 3 3 4 2 12 0 44
11
Other
(Please
specify)
0 0 0 0 0 0 0 0 0 0 44 44
248
Total 44 44 44 44 44 44 44 44 44 44 44 -

Other (Please specify)

249
Statist
ic
Regul
atory
restri
ctions
on
custo
mer
intera
ction
Unce
rtain
pote
ntial
of
socia
l
medi
a to
creat
e
value
Uncer
tain
retur
n on
invest
ment
Regul
atory
compl
iance
risk
Insuff
icient
resou
rces
Chall
enges
with
monit
oring
Fear of
enforc
ement
action
s
Loss
of
con
tent
con
trol
Priv
acy
conc
erns
Lack
of
clear
guid
ance
Oth
er
(Ple
ase
spe
cify)
Min
Value
1 1 1 1 1 1 1 1 3 1 11
Max
Value
8 10 10 9 10 10 10 9 10 10 11
Mean 3.18 5.73 6.75 3.14 6.18 5.05 6.16
5.2
3
7.61 5.98
11.
00
Varia
nce
4.43 8.16 8.56 4.21 7.59 4.93 6.65
5.4
8
4.24
11.2
8
0.0
0
Stand
ard
Devia
tion
2.11 2.86 2.93 2.05 2.76 2.22 2.58
2.3
4
2.06 3.36
0.0
0
250
Total
Resp
onses
44 44 44 44 44 44 44 44 44 44 44

251
16. Please rank the importance that your company places on the following in the uses of social
media from most to least important with 1 being the most important.
# Answer 1 2 3 4
Total
Responses
1
Social and customer
care (e.g. customer
retention, provision of
services or information)
9 19 15 1 44
2
Reputation
management
(protection, defense,
enhancement of brand)
15 8 9 12 44
3
Marketing (product
awareness, outreach)
17 14 5 8 44
4
Feedback from
customers/stakeholders
(e.g. competitive
insights, identification
of customer issues)
3 3 15 23 44
Total 44 44 44 44 -
252

Statistic
Social and
customer care
(e.g. customer
retention,
provision of
services or
information)
Reputation
management
(protection,
defense,
enhancement
of brand)
Marketing
(product
awareness,
outreach)
Feedback from
customers/stakeholders
(e.g. competitive
insights, identification
of customer issues)
Min Value 1 1 1 1
Max Value 4 4 4 4
Mean 2.18 2.41 2.09 3.32
Variance 0.62 1.50 1.25 0.78
Standard
Deviation
0.79 1.23 1.12 0.88
Total
Responses
44 44 44 44

253
17. As a vehicle for consumers to receive timely information on product safety, how would your
company rank the following channels for dissemination of information with 1 being the most
timely?
# Answer 1 2 3 4 5 6
Total
Responses
1
FDA
website
13 9 4 5 2 12 45
2
Your
company's
website
16 12 7 7 2 1 45
3
Website of
closest
competitor
1 5 7 5 15 12 45
4
Web MD
or similar
3 2 11 5 14 10 45
5
Consumer
blogs
8 8 8 8 8 5 45
6
Patient
advocacy
or support
4 9 8 15 4 5 45
254
group
Total 45 45 45 45 45 45 -

Statistic
FDA
website
Your
company's
website
Website of
closest
competitor
Web MD
or similar
Consumer
blogs
Patient
advocacy
or support
group
Min Value 1 1 1 1 1 1
Max Value 6 6 6 6 6 6
Mean 3.22 2.33 4.42 4.22 3.33 3.47
Variance 4.09 1.82 2.07 2.22 2.73 2.07
Standard
Deviation
2.02 1.35 1.44 1.49 1.65 1.44
Total
Responses
45 45 45 45 45 45

255
18. As a vehicle for consumers to receive reliable information on product safety, how would
your company rank the following channels for dissemination of information with 1 being the
most reliable.
# Answer 1 2 3 4 5 6
Total
Responses
1
FDA
Website
21 14 3 3 1 1 43
2
Your
company's
website
19 16 4 1 2 1 43
3
Website of
closest
competitor
0 1 9 9 10 14 43
4
Web MD
or similar
1 5 12 9 8 8 43
5
Consumer
blogs
2 3 5 9 9 15 43
6
Patient
advocacy
or support
0 4 10 12 13 4 43
256
group
Total 43 43 43 43 43 43 -

Statistic
FDA
Website
Your
company's
website
Website of
closest
competitor
Web MD
or similar
Consumer
blogs
Patient
advocacy
or support
group
Min Value 1 1 2 1 1 2
Max Value 6 6 6 6 6 6
Mean 1.88 1.93 4.63 3.98 4.51 4.07
Variance 1.44 1.45 1.48 1.93 2.21 1.30
Standard
Deviation
1.20 1.20 1.22 1.39 1.49 1.14
Total
Responses
43 43 43 43 43 43

257
19. What does your company do with data collected from social media? Please explain.
Text Response
Public affairs track all social media info and meets with Corporate to discuss the data
I'm not aware. Our corporate team doesn't share insights
Understand product performance and feedback for next generation products.
Controlled by Public Affairs; I am in regulatory so I really don't know what they
specifically do.
Inforamtion is used to determine the most effective and most popular social media
sites, and to build knowledge on what customers are saying about our company and our
products.
Review in teams and disseminate feedback to organizational teams for improvement or
new technologies.
The data is used to gauge customer satisfaction and retention, brand awareness and
product positioning
Build strategies for targeted marketing and compare company vs. competitors'
participation in social media
Right now we just gather for metrics on how many views we get.
258
Monitor for SAEs, compile for marketing use
I am not involved in that.
We use anonymous insights for internal learnings
They monitor how much activity we get and tie that to brand awareness.
we are developing more robust processes to better understand the data and feed back
to the marketing teams in charge of developing the content for the following cycle - we
are at the early stages
We do not collect feedback through social media due to limited resources to monitor
and fear of not meeting FDA compliance.
for complaint handling, marketing and new product development purpose
Data collected is mostly in the form of outreach potential
analyze patterns, feedback, insights
The company monitor social media. Routine two way communication is not done in
ADD. Often ADD engages customers through social media to elicit feedback on key
topics through surveys.
for complain handling, inputs to product improvement or future product development,
259
inputs to process improvement, etc.
i'm not aware that we collect that type of data
review for complaints, other is unknown to me.
Not sure
Fine tune the marketing plan
Monitor consumer reach, engagement, and sentiment to inform brand marketing
(company & product level), manage corp reputation, monitor key influencers, etc.
Demonstrate to physicians the number of leads Abbott is generating for their practice
Unsure what this question means - what data specifically?
We do not currently collect data.
Measure interest in programs.
We are not currently collecting data
New product ideas/concepts.
Leverage it to inform product improvements, better meet consumer preferences, refine
marketing mix
260
We have not engaged in Social Media fully at this point
We use it for market research.
We do not currently collect social media.
for future product planning based on customer feedback and comments
Not engaged in social media currently
Inform decisions on content strategy for our specific purposes and measure brand
perception / sentiment

20. What are your views as the business advantages associated with participating in social
media? Please explain
Text Response
you can reach as many customers as you can in a short period of time but lack of
guidance from the FDA is making it hard to participate
Rapid/viral communication channel (for good or bad)
Cost effectiveness, and ease of reach for general patient population
Potentially build your brand awareness, moving toward an emotional connection.
The advantages include low start-up costs, increased awareness of the company and
261
products, and reaching a wider audience quickly.
Support it.
The cost efficiency of promoting in social media along with the ease and value of
interaction with customers
Low start-up costs, gain brand and company awareness broadly vs. traditional media,
easy and fast access to and dissemination of information
We could do alot more, we need to get deeper metrics and see exactly who is viewing
and using the informationn we put out there.
It is an economical/efficient way to help promote our brands and engage consumers.
low cost way to reach a wide audience
Brand reputation; being able to serve our community by listening and providing useful
information that helps the community
Keeping our name out there. Reaching the social media savvy crowd. Being able to take
a random poll. Having a direct line to people.
brand awareness is probably measurable, part of the marketing mix, globally efficient,
and can be made locally relevant. difficult to develop ROI, but data is very very useful if
262
harnessed
It's a timely way to determine how your product is doing with consumers and product
awareness.
be part of online patient community, get direct real time feedback from customers,
improve company image and disseminate information
the advantages are still unknown really as they compare to the costs- use has been
mostly in non- product specific areas
faster and cheaper reach to consumers; tapping into key opinion leaders and trend
setters among consumers
I feel it is acceptable, but our company needs ot have Regulatory Affairs involved which
many times does not occur. Public Affairs controls social media with little oversight.
improving company image and reputation, engaging directly with users, getting timely
market feedback, and having an effective way of disseminating information, etc.
Another avenue to reach the patient and provide timely information, for the customer it
may decrease their cost of obtaining information
our customers expect us to participate. if we don't, we lose this connection. its a quick
263
way to notify customers and reps on new product.
Not a choice, a company has to be engaged or they are behind the times.
Need clear goals and strategy, clear road path backed by right content, quick response
system, thick skin to bear criticism
Represents a major (and growing) channel through which consumers are viewing media,
in developed and emerging markets. Facilitates deeper consumer engagement vs.
traditional media. HUGE earned media upside and opportunity to drive positive
advocacy. Enables "adaptive marketing" / advanced analytics to maximize campaign
effectiveness. Provides deeper consumer inights, and is an effective tool for monitoring
competitor consumer engagement. Potential for earlier identification of regulatory
related product issues.
it is a must have as to not be present removes a key opportunity to drive awareness,
interact with and influence patients
Extremly important from a marketing/PA perspective - just needs to be handled in a
very specific way.
Direct and unfiltered feedback from the consumer. Ability to positively direct your
brand's online consumer experience.
264
A more convenient connection with our customers
The business advantage of participation in social media is questionable for our product
line, most of which is for professionals
Increase brand awareness and product sales.
engagement with consumers, valuable communication channel
Difficult to gauge at this point when the FDA has issued draft guidances that are
restrictive for product information vs risks
Return on investments and more sales
So far, it is difficult to justify the business investment in platforms like Facebook,
Twitter, etc. especially for medical devices. In my view the more compelling ways to
participate in social media are having an excellent web page to educate consumers
about product, robust SEO tools to make sure consumers can find the product, and a
good online reputation for consumers seeking to understand the product.
live feedback, dynamic
Improved SEO, which leads to higher acquisition. Clear concrete goal.
Almost a necessity today to become a relevant brand in the consumers' mind

265
Statistic Value
Total Responses 38

266
21. Which of the following concerns would influence your decisions regarding the ways that
your company use social media?
# Question Major Minor None
Cannot
Answer
Total
Responses
Mean
1
Fear of
regulatory
non-
compliance
39 4 1 0 44 1.14
2
Disclosure
of
proprietary
information
20 24 0 0 44 1.55
3
Public
criticism of
company
23 19 2 0 44 1.52
4
Violations
of privacy
laws
24 18 1 1 44 1.52
5
Ability to
manage
21 22 1 0 44 1.55
267
out of date
/
inaccurate
Information
6
Fear of no
turning
back once a
channel
exists
14 25 5 0 44 1.80
7
Manpower
costs
18 19 4 3 44 1.82

268
Statistic
Fear of
regulatory
non-
complianc
e
Disclosure
of
proprietar
y
informatio
n
Public
criticism
of
compan
y
Violation
s of
privacy
laws
Ability to
manage
out of
date /
inaccurate
Informatio
n
Fear of
no
turning
back
once a
chann
el
exists
Manpowe
r costs
Min
Value
1 1 1 1 1 1 1
Max
Value
3 2 3 4 3 3 4
Mean 1.14 1.55 1.52 1.52 1.55 1.80 1.82
Variance 0.17 0.25 0.35 0.44 0.30 0.40 0.76
Standard
Deviation
0.41 0.50 0.59 0.66 0.55 0.63 0.87
Total
Response
s
44 44 44 44 44 44 44

269
22. Of the following choices, which do you think is best suited to provide a balanced
presentation of both risks and benefits of medical products?

270
# Answer

Response %
1
Provide the
user with a web
link that directs
the user to the
complete
risk/benefit
statement

16 36%
2
Include the
complete
risk/benefit
statement in
the promotion

10 22%
3
Provide
manufacturer's
contact
information to
procure the
risk/benefit
statement

2 4%
271
4
Include
summary of
risk/benefits

15 33%
5
Other (Please
explain)

2 4%
Total

45 100%

Other (Please explain)
Include a summary of risk/benefits and a link to the complete risk/benefit statement
I feel a combination is required (A and D).

272
23. Do you think that regulations that currently restrict company use of social media deprive
patients of important safety & efficacy information?

273
# Answer

Response %
1
Yes,
restrictions
on industry
reduce the
safety of
products

14 31%
2
No,
restrictions
have no
effect on
safety

6 13%
3
No,
restrictions
make
product safer

8 18%
4 Not sure

17 38%
Total

45 100%

274
24. How would your company most likely deal with a situation in which it discovered that a
competitor was not compliant with DTC rules?

275
# Answer

Response %
1
Communicate
formally to the
company

22 51%
2 Report to FDA

18 42%
3
Initiate a legal
action

3 7%
4
Send cease
and desist
letter to
competitor

13 30%
5 No action

6 14%
6
Other (Please
Specify)

7 16%

276
Other (Please Specify)
Take whatever action is required by Regulatory authorities
I am not sure that I know the answer to this question, but I would guess that we would
not take action
it depends on the severity and impact of the violation
Not sure, depends on the extent of non compliance and its assessed impact on
consumers
Not my call
Will inform Corporate Legal Counsel of the situation and let them decide on the next
steps
Not sure, perhaps send cease and desist letter to competitor

277
25. Would your company escalate its actions if they believed that their actions affected
patient/public safety?

# Answer

Response %
1 Yes

37 84%
2 No

1 2%
3
Do not
know

6 14%
Total

44 100%

278

26. "The FDA issues enforcement actions more frequently against large companies versus small
companies?" Do you agree with this statement?

279
# Answer

Response %
1
Strongly
Disagree

3 7%
2 Disagree

4 9%
3
Neither
Agree nor
Disagree

14 31%
4 Agree

14 31%
5
Strongly
Agree

10 22%
Total

45 100%

280
27. Which social media forums do you view as the most effective in promoting your product,
with 1 being the most effective?
# Answer 1 2 3 4 5 6
Total
Responses
1
Discussion
Forum
9 10 6 8 10 0 43
2 Facebook 13 7 5 11 6 1 43
3 You Tube 9 10 11 7 5 1 43
4 Blogs 6 8 10 12 7 0 43
5
Microblogs
(e.g.
Twitter)
4 8 10 5 14 2 43
6
Other
(Please
Specify)
2 0 1 0 1 39 43
Total 43 43 43 43 43 43 -

281
Statistic
Discussion
Forum
Facebook You Tube Blogs
Microblogs
(e.g.
Twitter)
Other
(Please
Specify)
Min Value 1 1 1 1 1 1
Max Value 5 6 6 5 6 6
Mean 3.00 2.84 2.81 3.14 3.53 5.67
Variance 2.24 2.43 1.92 1.69 2.16 1.32
Standard
Deviation
1.50 1.56 1.38 1.30 1.47 1.15
Total
Responses
43 43 43 43 43 43

282
28. In your company's view, how likely is it that your company will increase social media
spending over the next 3 years?

283
# Answer

Response %
1 Very Unlikely

2 4%
2 Unlikely

1 2%
3
Somewhat
Unlikely

2 4%
4
Somewhat
Likely

8 18%
5 Likely

15 33%
6 Very Likely

17 38%
Total

45 100%

284
29. Do you have a written procedure governing the use of social media?

# Answer

Response %
1 Yes

42 93%
2 No

2 4%
3
Do not
know

1 2%

285
30. Some have suggested that promotion by social media should be governed by an entity other
than the FDA. Which group(s) would you prefer to oversee advertisement and promotion using
social media? Please check all that apply.

286
# Answer

Response %
1 FDA

20 49%
2 FTC

22 54%
3
Self-
Regulated

10 24%
4
Other
(Please
specify)

1 2%

Other (Please specify)

287
31. Do you think that it is feasible for industry to monitor social media for adverse events?

# Answer

Response %
1
Technically
feasible

11 24%
2 Possible

21 47%
3 Desirable

7 16%
4 Reasonable

6 13%
Total

45 100%

288
32. How should FDA regulate social media interactions by agents of the company?

289
# Answer

Response %
1
Requires that
company
submits
promotional
materials to
FDA before
release

8 19%
2
Require that
company
submits
promotional
materials to
FDA after
release

7 17%
3
Make
submission of
promotional
materials
voluntary

27 64%
290
Total

42 100%

33. Has your company had any enforcement actions because of its use of social media?

291
# Answer

Response %
1 Yes

0 0%
2 No

34 76%
3
Do not
know/Cannot
answer

11 24%
Total

45 100%

292
34. Do you believe that social media should be regulated according to present advertising and
promotion rules?

# Answer

Response %
1 Yes

16 36%
2 No

18 40%
3
Do not
know/cannot
answer

11 24%
Total

45 100%

293

294
35. If you chose "No", which of the following allows industry to fulfill the adequate provision
requirements?

295
# Answer

Response %
1
The use of
links to
provide risk
information

12 67%
2
Contact
customer
service for
risk
information

3 17%
3
Other (Please
Specify)

3 17%
Total

18 100%

296
Other (Please Specify)
Summary even if forced to be very abbreviated such as on Twitter
Incude
regulations should cover the level of detialed that can be provided to answer a patients
questions, especially about safety. should always advise to talk with physician

36. FDA has recently released the proposed guidance for "fulfilling regulatory requirements
for postmarketing submissions of interactive promotional media for prescription human and
animal drugs and biologics". Are you familiar with the guidance?

297
# Answer

Response %
1 Very familiar

9 20%
2
Modestly
familiar

18 41%
3 Not familiar

17 39%
Total

44 100%

298
37. What is your view on the following statements?
# Question
Strongl
y
Agree
Agre
e
Somewh
at Agree
Disagre
e
Strongl
y
Disagre
e
Canno
t
Judge
Total
Respons
es
Mea
n
1
The new
guidance
makes it
clear how
to interact
with social
media
0 3 14 8 1 1 27 3.37
2
The
alignment
between
rules for
social
media and
convention
al media
are
appropriate
0 5 12 6 1 3 27 3.44
299
3
The new
requiremen
ts regarding
submission
of
interactive
promotiona
l media will
encourage
industry to
use social
media more
1 2 8 8 3 4 26 3.85

300
Statistic
The new guidance
makes it clear how to
interact with social
media
The alignment
between rules for
social media and
conventional media
are appropriate
The new
requirements
regarding submission
of interactive
promotional media
will encourage
industry to use social
media more
Min Value 2 2 1
Max Value 6 6 6
Mean 3.37 3.44 3.85
Variance 0.78 1.41 1.74
Standard Deviation 0.88 1.19 1.32
Total Responses 27 27 26

301
38. Please rate your agreement or disagreement with the following statements?
# Question
Strongl
y
Agree
Agre
e
Somewh
at Agree
Disagre
e
Strongl
y
Disagre
e
Canno
t
Judge
Total
Respons
es
Mea
n
1
The
guidance
explains
well how to
use social
media with
space
limitations
(e.g.
twitter)
0 2 10 11 1 2 26 3.65
2
The
guidance
provides an
adequate
framework
for my
promotiona
0 2 10 10 2 2 26 3.69
302
l activities
3
The
guidance
makes
compliance
activities
more
difficult
than it was
before
4 3 7 5 1 6 26 3.54
4
The
guidance is
clear on
when
enforcemen
t discretion
will be used
by the FDA
0 3 11 7 2 3 26 3.65
5
More
5 9 8 1 0 3 26 2.65
303
resources
will be
needed by
industry to
comply
with the
guidance
6
The
guidance
clarifies
reporting
requiremen
ts for my
company
0 4 14 5 1 2 26 3.35

304
Statistic
The
guidance
explains
well how
to use
social
media
with
space
limitation
s (e.g.
twitter)
The
guidance
provides an
adequate
framework
for my
promotiona
l activities
The
guidance
makes
complianc
e activities
more
difficult
than it was
before
The
guidance is
clear on
when
enforcemen
t discretion
will be used
by the FDA
More
resource
s will be
needed
by
industry
to
comply
with the
guidance
The guidance
clarifies
reporting
requirement
s for my
company
Min Value 2 2 1 2 1 2
Max Value 6 6 6 6 6 6
Mean 3.65 3.69 3.54 3.65 2.65 3.35
Variance 0.96 1.02 2.98 1.36 2.16 1.12
Standard
Deviation
0.98 1.01 1.73 1.16 1.47 1.06
Total
Response
s
26 26 26 26 26 26

305
39. Which of the following areas does your company find problematic? Please check all that
apply.
# Question
Extremel
y
Problema
tic
Very
Problema
tic
Somewh
at
Problema
tic
Neither
problema
tic nor
not
problema
tic
Not
problema
tic
Total
Respons
es
Mea
n
1
Reporting
Requireme
nts to FDA
2 2 9 9 3 25
3.3
6
2
The scope
of the 'any
control or
influence"
test
2 4 9 6 3 24
3.1
7
3
Making the
determinat
ion of
when an
employee
or agent is
acting on
3 3 6 5 7 24
3.4
2
306
behalf of
the
company
4
Other
(Please
Specify)
0 1 3 3 3 10
3.8
0

307
Statistic
Reporting
Requirements to
FDA
The scope of the
'any control or
influence" test
Making the
determination of
when an
employee or
agent is acting on
behalf of the
company
Other (Please
Specify)
Min Value 1 1 1 2
Max Value 5 5 5 5
Mean 3.36 3.17 3.42 3.80
Variance 1.16 1.28 1.91 1.07
Standard
Deviation
1.08 1.13 1.38 1.03
Total
Responses
25 24 24 10

308
40. What is your view about the overall impact of the guidance document in assessing
the regulatory risk of continuing or initiating the use of social media platforms in the medical
industry?

309
# Answer

Response %
1 Much Worse

1 4%
2 Worse

1 4%
3
Somewhat
Worse

2 8%
4
About the
Same

11 46%
5
Somewhat
Better

8 33%
6 Better

0 0%
7 Much Better

1 4%
Total

24 100%

310
APPENDIX C
Cross Tabulation and Analysis
Cross Tabulation 1: Product category against Company’s annual revenue

Cross Tabulation 2: FDA Guidance against Job Function

Cross Tabulation 3: Promotional Activities against Company’s annual revenue
311

Cross Tabulation 4: Social media channels used against product categories

Abstract (if available)

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Asset Metadata

Creator Dankwah, Kwabena A. (author)

Core Title Promotion of regulated products using social media: an industry view

School School of Pharmacy

Degree Doctor of Regulatory Science

Degree Program Regulatory Science

Publication Date 04/15/2015

Defense Date 02/04/2015

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag advertising and promotion,Compliance,FDA,First Amendment,level playing field,market access,OAI-PMH Harvest,Safety,social media,theories of regulation

Format application/pdf (imt)

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Davies, Daryl L. (committee chair), Loeb, Gerald E. (committee member), Richmond, Frances J. (committee member), Vanderveen, Pete (committee member)

Creator Email dankwah@usc.edu,kobby.dankwah@abbott.com

Permanent Link (DOI) https://doi.org/10.25549/usctheses-c3-550574

Unique identifier UC11298236

Identifier etd-DankwahKwa-3305.pdf (filename),usctheses-c3-550574 (legacy record id)

Legacy Identifier etd-DankwahKwa-3305.pdf

Dmrecord 550574

Document Type Dissertation

Format application/pdf (imt)

Rights Dankwah, Kwabena A.

Type texts

Source University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

Access Conditions The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the a...

Repository Name University of Southern California Digital Library

Repository Location USC Digital Library, University of Southern California, University Park Campus MC 2810, 3434 South Grand Avenue, 2nd Floor, Los Angeles, California 90089-2810, USA