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Response to Request for Comment U.S. Food and Drug Administration Comments Concerning Draft Guidance, Document No. 2011-33550The Public Relations Society of America (“PRSA”) and the Word of Mouth Marketing Association(“WOMMA”) are pleased to submit these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 UnitedStated Food and Drug Administration’s (“FDA”) invitation for comments regarding its Draft Guidancefor Industry Responding to Unsolicited Request for Off-Label Information About Prescription Drugs andMedical Devices (the “Guidelines” or the “Guidance”).PRSA (www.PRSA.org) is the leading global professional association of public relations andcommunications professionals. PRSA represents 22,000 professional communicators in the publicrelations and public affairs communities, and some 10,000 students in its affiliated organization, thePublic Relations Student Society of America. PRSA is responsible for representing, educating, settingstandards of excellence and best practices, providing certification and upholding principles of ethics forits members, and more broadly, the $5.7 billion U.S. public relations industry.Members of PRSA include: independent practitioners; small business owners; employees of governmentagencies; corporations; academic institutions; law firms and professional services practices; publicrelations 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 comprehensivemix of marketing communications and advertising strategies to achieve client objectives. Members ofPRSA abide by a mandatory Code of Ethics that establishes core values, principles and practiceguidelines that define their professionalism and advance their success.WOMMA (www.WOMMA.org) is the leading trade association in the marketing and advertisingindustries that focuses on word-of-mouth, consumer-generated and social media platforms — marketingtechniques that include buzz, viral, community and influencer marketing as well as brand blogging andenhancement. Founded in 2005, WOMMA has approximately 450 members, which include: (i) marketersand brands that use word of mouth marketing to reinforce their core customers and to reach out to newconsumers; (ii) agencies that deliver word-of-mouth services and technologies; (iii) researchers that trackthe 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 evaluateand execute marketing campaigns. This Code, in fact, was favorably recognized by the Federal TradeCommission in the agency’s recent release of its Guides Concerning the Use of Endorsements andTestimonials in Advertising.Focus of PRSA / WOMMA CommentsWe are providing these comments to ensure the continued strength of open and honest communicationsthat help foster informed decision-making in America.Comments of Public Relations Society of America and Word of Mouth Marketing Association toFDA Document No. 2011-33550 Page 1

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Furthermore, given PRSA’s mission to advance the public relations profession and professional, andWOMMA’s commitment to developing and maintaining appropriate ethical standards for marketers,advertisers, and brands engaging in such marketing practices, identifying meaningful measurementstandards for such marketing practices, and defining “best practices” for the industry, our mutual interestis in ensuring the more than 200,000 professional communicators in the United States, many of whomwork in the health care or pharmaceutical industries, are provided with proper guidance concerning howto 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 concerningbrands’ online interactions with consumers, the Guidelines provide a workable platform upon which todevelop more robust guidance and industry standards.While a start, the Guidelines do not go far enough in properly guiding pharmaceutical and health carecommunicators and marketers as to the legal and appropriate means by which they can communicate withand market to consumers in response to requests for off-label information about prescription drugs andmedical devices.The proposed Guidelines fail to address the dynamic impact that social media and digital communicationshave had on American consumers and on society’s decision-making processes. As more consumers seekopportunities 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 howthey 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 PewInternet & American Life Project1, there is an urgent need for the FDA to provide the health care andpharmaceutical industries with proper guidance on how, when and where they can use social media andother direct-to-consumer communications and marketing platforms to engage with and respond toconsumers.It is not only marketers and communicators that are actively seeking opportunities to distribute health careand wellness information via social media communications in the pharmaceutical and health careindustries; it is consumers themselves, who want access to information and representatives fromcompanies that can quickly and efficiently answer their questions. According to a 2012 report byManhattan Research2, “42 percent of online adults agree that pharmaceutical companies should beinvolved in online health communities for consumers.” That same report also found that consumer use ofsocial media for health is on the rise — growing from 63 million U.S. adults accessing health-relateduser-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 issuespharmaceutical and health care communicators and marketers face in effectively educating andcommunicating with consumers about valuable information they need to improve their lives. It will alsodeprive 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 toHealth and Health Care.” It is published at: http://www.pewinternet.org/Commentary/2011/November/Pew-Internet-Health.aspx2 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 toFDA Document No. 2011-33550 Page 2

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This, we believe, is hindering the development of innovative and needed communications betweenbusinesses and consumers.Guidelines Need to Provide Specific RecommendationsThe American public and health care marketers are equally deserving of the opportunity to communicatewith one another online in a manner that protects their respective interests. The FDA’s work is critical toovercoming key obstacles in this regard.We also appreciate that the FDA has an obligation to protect consumer welfare and serve as an advocatefor consumers; those interests include the public’s online interactions and communications withbusinesses and their representatives.If consumers can’t find the information they want and/or need online from businesses then they are goingto go elsewhere to find such information indirectly. It is the responsibility of the FDA to protectconsumers and develop a regulatory framework within the marketplace that both supports innovation andprovides for proper constraints that protect the public’s best interests and allows for the most direct andaccurate exchange of information.The proposed Guidelines do not meet these requirements as they continue to ignore the public’s desire toaccess 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 thathave been presented are not of the level necessary to properly protect consumer interests and ensurehealth 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, theprolonged delay in developing proper social-media guidelines is a detriment to the online patientcommunities who rely on these communications for information and support.Our members in the public relations, word-of-mouth and digital marketing industries are committed toresponsible, ethical and transparent communications in the social media space, and they need the FDA’sguidance on how to do so properly and appropriately. We believe that by providing communicators andmarketers 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 businessescan continue to innovate, both in their online marketing communications strategies and productdevelopment.Our members need the FDA’s guidance on how to do so properly and appropriately.Concerns with the GuidanceWe understand and appreciate the FDA’s stated concerns that any specific guidance relevant totechnologies or social networks may preclude the Guidelines from being useful in the years to come astechnology and platforms change. However, more than five years into the age of social media, the timehas come for the FDA to properly guide those industries that it regulates — in this case, pharmaceuticaland health care companies and organizations — about ways in which they can specifically use certainsocial networks to communicate with and market consumers.Comments of Public Relations Society of America and Word of Mouth Marketing Association toFDA Document No. 2011-33550 Page 3

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Because of a lack of proper guidance from government regulators, the pharmaceutical sector, in ourestimation, is at least four years behind the consumer side of social media marketing andcommunications. This has led to numerous issues that continue to persist, both for marketers andconsumers.For example, Why can’t people find timely and relevant information about specific pharmaceuticalproducts or medical devices in social networks? Consumers are spending increasing amounts of timeonline, particularly on social networks, or are augmenting their real-world physical shopping experienceswith digital devices that help them make more informed decisions. Nine out of 10 U.S. consumers visiteda social network at least once a month last year, according to Web measurement firm comScore Inc.3Social media is fast becoming a top choice among consumers for finding health care information. A 2011survey conducted by the National Research Corporation found that of 23,000 Americans surveyed, 16percent said they use social media to learn more about health issues4. One in four respondents5 said whatthey learned on these sites was “very likely” or “likely” to impact their future health decisions, with 32percent saying they have a “very high” or “high” level of trust in the information about health care theyobtain via social media.We believe these physical-digital search and shopping experiences can and should be enhanced byresponsible and ethical communications between pharmaceutical and health care companies andconsumers.Suggestions Relating to Overall GuidanceThis emerging reality should be met by a robust set of Guidelines from the FDA. That guidance mightcover: • 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 inwhich companies can proactively and reactively communicate with consumers online, via social mediaand other digital forums, in a manner that answers their questions, provides information and aids insociety’s informed decision making.As it stands now, much of the burden is placed on consumers to access information from companies. Thisdoes not reflect the realities of the digital age, in which people have access to almost unlimited amountsof information and data. Organizations need to be providing consumers with accurate, unbiasedinformation direct from the source. Instead, consumers are forced to find “work-arounds” to access3 “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 ispublished at: http://hcmg.nationalresearch.com/public/News.aspx?ID=9.Comments of Public Relations Society of America and Word of Mouth Marketing Association toFDA Document No. 2011-33550 Page 4

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information online, thus subjecting them to potentially spurious or unethical marketing practices or thetransmission of incorrect information.While we appreciate the challenge of providing comprehensive guidelines to the industry wheretechnology is changing on a daily basis, we believe that the FDA could issue core principles andregulatory standards that could guide the industry toward regulatory responsibility while not chilling theirability to communicate with consumers who desire to know essential information. Specifically, we wouldrecommend that the FDA provide the industry with the following four core fundamental principles thatgovern operating procedures:Principle No. 1: Companies have a fundamental interest in participating in social media platformsconcerning the medicines or products they provide, and the conditions these medicines and productsaddress.Principle No. 2: Governmental regulation concerning such participation must only relate to thosecommunications that constitute commercial promotional activities sponsored by the companies.Principle No. 3: Any governmental regulation concerning such commercial promotional activity must benarrowly and appropriately tailored to ensure that those communications are (i) truthful; (ii) balanced andnot deceptive; and (iii) transparent.Principle No. 4: Any such governmental regulation must account for the nature and navigational realitiesof various social media platforms, such as the ability to use links and space constraints in certainenvironments or platforms.In addition, we would recommend that the FDA provide the industry with the following regulatorystandards 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 promotionalcommunications directed to consumers and (b) are intentionally sponsored by the company. In otherwords, FDA regulatory guidelines concerning advertising by pharma and other health care companies areto apply only to those communications that (i) are sponsored and (ii) constitute promotional messagesdesigned 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 isunder the company’s control, ownership, or operation; or for that content they specifically provide tothird-parties, such as WebMD.Standard 3: Companies are responsible for monitoring only those platforms or communications that areunder their “sphere of influence.” In other words, companies are responsible for monitoring the discussiononly 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 toFDA Document No. 2011-33550 Page 5

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Standard 4: Companies are responsible for reporting adverse events only in those circumstances arisingfrom their monitoring activities (as described in Standard No. 3 above). Yet, in monitoring and evaluatingsuch adverse event incidents, the privacy interests of consumers must be respected.Standard 5: Any content for which companies are responsible must be transparent, disclosing allmaterial connections between the company and the speaker.Note: The Guides for the Use of Testimonials and Endorsements in Advertising recently provided by theFederal Trade Commission provide an appropriate framework.Standard 6: For content that requires disclosures that are needed to prevent deceptive or misleadinginformation, companies are responsible to ensure that such disclosures be made clearly and conspicuouslygiven the practical constraints of the particular platform used.Note: The “clear and conspicuous” standard by the Federal Trade Commission provides an appropriateand 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 tocontinuing to work with the FDA to promote innovation and protect consumers. Please contact KeithTrivitt at (212) 460-1495 or keith.trivitt@prsa.org, or Anthony DiResta at (202) 282-5782 oradiresta@winston.com with questions.Respectfully submitted,Gerard F. Corbett, APR, Fellow PRSAChair and Chief Executive OfficerPublic Relations Society of Americagerard.corbett@prsa.org(212) 460-1400Anthony E. DiRestaGeneral Counsel, WOMMAWINSTON &STRAWN LLP1700 K Street, N.W.Washington, D.C. 20006adiresta@winston.com(202) 282-5782Comments of Public Relations Society of America and Word of Mouth Marketing Association toFDA Document No. 2011-33550 Page 6