The Public Relations Society of America and the Word of Mouth Marketing Association filed joint comments with the U.S. Food and Drug Administration concerning guidelines for pharmaceutical companies' use of social media.

6. Response to Request for Comment
U.S. Food and Drug Administration
Comments Concerning Draft Guidance, Document No. 2011-33550
The Public Relations Society of America (“PRSA”) and the Word of Mouth Marketing Association
(“WOMMA”) are pleased to submit these comments and recommendations in response to the United
Stated Food and Drug Administration’s (“FDA”) invitation for comments regarding its Draft Guidance
for Industry Responding to Unsolicited Request for Off-Label Information About Prescription Drugs and
Medical Devices (the “Guidelines” or the “Guidance”).
PRSA (www.PRSA.org) is the leading global professional association of public relations and
communications professionals. PRSA represents 22,000 professional communicators in the public
relations and public affairs communities, and some 10,000 students in its affiliated organization, the
Public Relations Student Society of America. PRSA is responsible for representing, educating, setting
standards of excellence and best practices, providing certification and upholding principles of ethics for
its members, and more broadly, the $5.7 billion U.S. public relations industry.
Members of PRSA include: independent practitioners; small business owners; employees of government
agencies; corporations; academic institutions; law firms and professional services practices; public
relations firms of all sizes and practice specialties; and nonprofit institutions of every size and description.
PRSA membership also includes professionals who engage in public relations as part of a comprehensive
mix of marketing communications and advertising strategies to achieve client objectives. Members of
PRSA abide by a mandatory Code of Ethics that establishes core values, principles and practice
guidelines that define their professionalism and advance their success.
WOMMA (www.WOMMA.org) is the leading trade association in the marketing and advertising
industries that focuses on word-of-mouth, consumer-generated and social media platforms — marketing
techniques that include buzz, viral, community and influencer marketing as well as brand blogging and
enhancement. Founded in 2005, WOMMA has approximately 450 members, which include: (i) marketers
and brands that use word of mouth marketing to reinforce their core customers and to reach out to new
consumers; (ii) agencies that deliver word-of-mouth services and technologies; (iii) researchers that track
the word-of-mouth experience; and (iv) offline and online practitioners.
Members of WOMMA abide by mandatory Standards of Conduct and a Code of Ethics that establishes
“best practices” guidelines designed to assist in the development of compliance procedures to evaluate
and execute marketing campaigns. This Code, in fact, was favorably recognized by the Federal Trade
Commission in the agency’s recent release of its Guides Concerning the Use of Endorsements and
Testimonials in Advertising.
Focus of PRSA / WOMMA Comments
We are providing these comments to ensure the continued strength of open and honest communications
that help foster informed decision-making in America.
Comments of Public Relations Society of America and Word of Mouth Marketing Association to
FDA Document No. 2011-33550 Page 1

7. Furthermore, given PRSA’s mission to advance the public relations profession and professional, and
WOMMA’s commitment to developing and maintaining appropriate ethical standards for marketers,
advertisers, and brands engaging in such marketing practices, identifying meaningful measurement
standards for such marketing practices, and defining “best practices” for the industry, our mutual interest
is in ensuring the more than 200,000 professional communicators in the United States, many of whom
work in the health care or pharmaceutical industries, are provided with proper guidance concerning how
to appropriately — and legally — market to and communicate with consumers online.
We appreciate the degree of consideration the FDA has given in developing its proposed Guidelines.
After more than five years of requests by businesses and marketers for proper guidance concerning
brands’ online interactions with consumers, the Guidelines provide a workable platform upon which to
develop more robust guidance and industry standards.
While a start, the Guidelines do not go far enough in properly guiding pharmaceutical and health care
communicators and marketers as to the legal and appropriate means by which they can communicate with
and market to consumers in response to requests for off-label information about prescription drugs and
medical devices.
The proposed Guidelines fail to address the dynamic impact that social media and digital communications
have had on American consumers and on society’s decision-making processes. As more consumers seek
opportunities to engage with businesses and discover valuable patient and health-care information online,
it is vital that the FDA provide businesses, communicators and marketers with proper guidance on how
they can deliver this information, via social media, in an appropriate manner.
Given that eight in 10 Internet users are looking online for health information, according to the Pew
Internet & American Life Project1, there is an urgent need for the FDA to provide the health care and
pharmaceutical industries with proper guidance on how, when and where they can use social media and
other direct-to-consumer communications and marketing platforms to engage with and respond to
consumers.
It is not only marketers and communicators that are actively seeking opportunities to distribute health care
and wellness information via social media communications in the pharmaceutical and health care
industries; it is consumers themselves, who want access to information and representatives from
companies that can quickly and efficiently answer their questions. According to a 2012 report by
Manhattan Research2, “42 percent of online adults agree that pharmaceutical companies should be
involved in online health communities for consumers.” That same report also found that consumer use of
social media for health is on the rise — growing from 63 million U.S. adults accessing health-related
user-generated content in 2008 to 107 million in 2011.
A continuing lack of detailed guidance for use of social media tools and platforms will prolong the issues
pharmaceutical and health care communicators and marketers face in effectively educating and
communicating with consumers about valuable information they need to improve their lives. It will also
deprive consumers of necessary information they need to make informed decisions regarding their health.
1
Pew Internet & American Life Project, “Pew Internet: Health — Highlights of the Pew Internet Project’s Research Related to
Health and Health Care.” It is published at: http://www.pewinternet.org/Commentary/2011/November/Pew-Internet-Health.aspx
2
Manhattan Research “ePharma Consumer(R) study.” It is published at: http://www.marketwatch.com/story/42-percent-of-
online-consumers-think-pharma-companies-should-be-involved-in-online-health-communities-addadhd-and-bipolar-disorder-
caregivers-top-groups-to-agree-2012-01-17.
Comments of Public Relations Society of America and Word of Mouth Marketing Association to
FDA Document No. 2011-33550 Page 2

8. This, we believe, is hindering the development of innovative and needed communications between
businesses and consumers.
Guidelines Need to Provide Specific Recommendations
The American public and health care marketers are equally deserving of the opportunity to communicate
with one another online in a manner that protects their respective interests. The FDA’s work is critical to
overcoming key obstacles in this regard.
We also appreciate that the FDA has an obligation to protect consumer welfare and serve as an advocate
for consumers; those interests include the public’s online interactions and communications with
businesses and their representatives.
If consumers can’t find the information they want and/or need online from businesses then they are going
to go elsewhere to find such information indirectly. It is the responsibility of the FDA to protect
consumers and develop a regulatory framework within the marketplace that both supports innovation and
provides for proper constraints that protect the public’s best interests and allows for the most direct and
accurate exchange of information.
The proposed Guidelines do not meet these requirements as they continue to ignore the public’s desire to
access information in an expedient and efficient manner online and via social media.
PRSA and WOMMA appreciate the complexity of the FDA’s assignment; however, the Guidelines that
have been presented are not of the level necessary to properly protect consumer interests and ensure
health care and pharmaceutical companies can retain an effective and robust presence in the emerging-
media landscape. This will only lead to a gap in open and transparent communication. Furthermore, the
prolonged delay in developing proper social-media guidelines is a detriment to the online patient
communities who rely on these communications for information and support.
Our members in the public relations, word-of-mouth and digital marketing industries are committed to
responsible, ethical and transparent communications in the social media space, and they need the FDA’s
guidance on how to do so properly and appropriately. We believe that by providing communicators and
marketers in the health care and pharmaceutical industries with proper and timely social-media guidance,
the FDA will help enhance the quality of information available to consumers, while ensuring businesses
can continue to innovate, both in their online marketing communications strategies and product
development.
Our members need the FDA’s guidance on how to do so properly and appropriately.
Concerns with the Guidance
We understand and appreciate the FDA’s stated concerns that any specific guidance relevant to
technologies or social networks may preclude the Guidelines from being useful in the years to come as
technology and platforms change. However, more than five years into the age of social media, the time
has come for the FDA to properly guide those industries that it regulates — in this case, pharmaceutical
and health care companies and organizations — about ways in which they can specifically use certain
social networks to communicate with and market consumers.
Comments of Public Relations Society of America and Word of Mouth Marketing Association to
FDA Document No. 2011-33550 Page 3

9. Because of a lack of proper guidance from government regulators, the pharmaceutical sector, in our
estimation, is at least four years behind the consumer side of social media marketing and
communications. This has led to numerous issues that continue to persist, both for marketers and
consumers.
For example, Why can’t people find timely and relevant information about specific pharmaceutical
products or medical devices in social networks? Consumers are spending increasing amounts of time
online, particularly on social networks, or are augmenting their real-world physical shopping experiences
with digital devices that help them make more informed decisions. Nine out of 10 U.S. consumers visited
a social network at least once a month last year, according to Web measurement firm comScore Inc.3
Social media is fast becoming a top choice among consumers for finding health care information. A 2011
survey conducted by the National Research Corporation found that of 23,000 Americans surveyed, 16
percent said they use social media to learn more about health issues4. One in four respondents5 said what
they learned on these sites was “very likely” or “likely” to impact their future health decisions, with 32
percent saying they have a “very high” or “high” level of trust in the information about health care they
obtain via social media.
We believe these physical-digital search and shopping experiences can and should be enhanced by
responsible and ethical communications between pharmaceutical and health care companies and
consumers.
Suggestions Relating to Overall Guidance
This emerging reality should be met by a robust set of Guidelines from the FDA. That guidance might
cover:
• Platform-specific issues.
• Disclosure.
• Conflicts-of-interest.
• Direct versus indirect communications.
We further suggest that the FDA provide for some form of responsible, self-regulated infrastructure in
which companies can proactively and reactively communicate with consumers online, via social media
and other digital forums, in a manner that answers their questions, provides information and aids in
society’s informed decision making.
As it stands now, much of the burden is placed on consumers to access information from companies. This
does not reflect the realities of the digital age, in which people have access to almost unlimited amounts
of information and data. Organizations need to be providing consumers with accurate, unbiased
information direct from the source. Instead, consumers are forced to find “work-arounds” to access
3
“Nearly 15% of the Time Consumers Spend Online Is on Facebook,” Internet Retailer, Feb. 13, 2012. It is published at:
http://www.internetretailer.com/2012/02/13/nearly-15-time-consumers-spend-online-facebook.
4
“Patients Use Facebook, Twitter to Get Health Information,” CNN.com, March 4, 2011. It is published at:
http://thechart.blogs.cnn.com/2011/03/04/patients-use-facebook-twitter-to-get-health-information/.
5
“1 in 5 Americans Use Social Media for Health Care Information,” Feb. 28, 2011. National Research Corporation. It is
published at: http://hcmg.nationalresearch.com/public/News.aspx?ID=9.
Comments of Public Relations Society of America and Word of Mouth Marketing Association to
FDA Document No. 2011-33550 Page 4

10. information online, thus subjecting them to potentially spurious or unethical marketing practices or the
transmission of incorrect information.
While we appreciate the challenge of providing comprehensive guidelines to the industry where
technology is changing on a daily basis, we believe that the FDA could issue core principles and
regulatory standards that could guide the industry toward regulatory responsibility while not chilling their
ability to communicate with consumers who desire to know essential information. Specifically, we would
recommend that the FDA provide the industry with the following four core fundamental principles that
govern operating procedures:
Principle No. 1: Companies have a fundamental interest in participating in social media platforms
concerning the medicines or products they provide, and the conditions these medicines and products
address.
Principle No. 2: Governmental regulation concerning such participation must only relate to those
communications that constitute commercial promotional activities sponsored by the companies.
Principle No. 3: Any governmental regulation concerning such commercial promotional activity must be
narrowly and appropriately tailored to ensure that those communications are (i) truthful; (ii) balanced and
not deceptive; and (iii) transparent.
Principle No. 4: Any such governmental regulation must account for the nature and navigational realities
of various social media platforms, such as the ability to use links and space constraints in certain
environments or platforms.
In addition, we would recommend that the FDA provide the industry with the following regulatory
standards for communications that advocate or promote a particular product for a consumer to purchase:
Standard 1: Companies are responsible only for those activities that (a) constitute promotional
communications directed to consumers and (b) are intentionally sponsored by the company. In other
words, FDA regulatory guidelines concerning advertising by pharma and other health care companies are
to apply only to those communications that (i) are sponsored and (ii) constitute promotional messages
designed to influence consumer purchasing decisions.
Example: Non-branded disease awareness communications do not constitute promotional
communications.
Standard 2: Companies are only responsible for content provided in social media communications that is
under the company’s control, ownership, or operation; or for that content they specifically provide to
third-parties, such as WebMD.
Standard 3: Companies are responsible for monitoring only those platforms or communications that are
under their “sphere of influence.” In other words, companies are responsible for monitoring the discussion
only when they have been actively engaged in the promotional messaging within that community.
Example: Companies should be responsible for monitoring discussion in a community that they
have created or posted content. If a brand representative goes into WebMD discussion boards and
posts information, the brand should monitor the follow-up discussions for questions,
misinformation, adverse event reporting and the like.
Comments of Public Relations Society of America and Word of Mouth Marketing Association to
FDA Document No. 2011-33550 Page 5

11. Standard 4: Companies are responsible for reporting adverse events only in those circumstances arising
from their monitoring activities (as described in Standard No. 3 above). Yet, in monitoring and evaluating
such adverse event incidents, the privacy interests of consumers must be respected.
Standard 5: Any content for which companies are responsible must be transparent, disclosing all
material connections between the company and the speaker.
Note: The Guides for the Use of Testimonials and Endorsements in Advertising recently provided by the
Federal Trade Commission provide an appropriate framework.
Standard 6: For content that requires disclosures that are needed to prevent deceptive or misleading
information, companies are responsible to ensure that such disclosures be made clearly and conspicuously
given the practical constraints of the particular platform used.
Note: The “clear and conspicuous” standard by the Federal Trade Commission provides an appropriate
and flexible approach.
We believe these principles and standards would be a prudent and proactive move forward by the FDA.
* * *
PRSA and WOMMA appreciate the opportunity to submit these comments and look forward to
continuing to work with the FDA to promote innovation and protect consumers. Please contact Keith
Trivitt at (212) 460-1495 or keith.trivitt@prsa.org, or Anthony DiResta at (202) 282-5782 or
adiresta@winston.com with questions.
Respectfully submitted,
Gerard F. Corbett, APR, Fellow PRSA
Chair and Chief Executive Officer
Public Relations Society of America
gerard.corbett@prsa.org
(212) 460-1400
Anthony E. DiResta
General Counsel, WOMMA
WINSTON &STRAWN LLP
1700 K Street, N.W.
Washington, D.C. 20006
adiresta@winston.com
(202) 282-5782
Comments of Public Relations Society of America and Word of Mouth Marketing Association to
FDA Document No. 2011-33550 Page 6