Coming Soon! FDA’s Current Thinking on Social Media and Product Promotion

Social media, the now-entrenched Internet phenomenon, enables decentralized and real time communication among small and large groups of individuals, organizations, and businesses.  Social media is a fast-paced, immediately gratifying interactive communication venue that allows website content to evolve and be transmitted instantaneously to an audience of anonymous, active or passive observers.

The ability to communicate so fluidly, however, renders social media communications reliably unpredictable and illusive, thus posing unique challenges for regulatory authorities as well as the companies they regulate, especially with regard to advertising.  One of those regulatory authorities, the Food and Drug Administration (“FDA”), has jurisdiction over companies involved with the manufacturing of medical products, such as drugs, biologics, medical devices, and emerging biotechnology products.

This article explains why even though various business sectors have fervently embraced social media as a product marketing tool, FDA-regulated industries have been slow to adopt this practice.  It also explores FDA’s emerging policy on Internet marketing activities and specifically the potential risks associated with using social media to disseminate promotional messages and scientific information about FDA-regulated prescription drugs and devices.  It then provides suggestions for weathering the next few months before FDA issues a guidance document on the promotion of prescription products using social media tools.

CURRENT INDUSTRY PRACTICE

Conversations through online social media communities among healthcare professionals, consumers, and others about FDA regulated prescription products and disease states have been taking place for some time.

Sermo, for example, one of the largest online physician social networks spanning 68 specialties in 50 states, provides a venue for over 112,000 physicians to exchange observations in real-time about drugs, devices and clinical issues.  Consumers are also discussing these issues.  Over 60 million consumers used social media to communicate and research health and medical information in 2008.[1]

What is lacking in many of these social media communications, however, is an authoritative source of information about prescription products and the conditions and diseases for which they are used.  As experts on their products, many companies want to serve in this capacity.  They want to disseminate information about their products through social media to ensure that accurate, transparent, high-quality information is being communicated to social media participants.  Many feel that this could be one of the best ways to reach target audiences effectively.

But companies are concerned about the not insignificant consequences of improper marketing, which can vary, yet may include the cost of remedial advertising, damage to reputation, and civil fines.^[2] The government has collected billions of dollars in fines, forfeitures, and disgorgements from drug companies over their off-label marketing practices, for example.[3] In the worst case, marketing a product for an unapproved, or “off-label,” use may be considered a strict liability misdemeanor that becomes a felony when there is intent to defraud or mislead.^[4] Companies are also concerned about the fact that FDA has provided little guidance on the use of the Internet, much less social media.

It is therefore not surprising that although many large companies may be using social media (e.g., Facebook, YouTube, LinkedIn, blogs, and Twitter) to disseminate information about corporate developments and health conditions or diseases, they are not using social media to market their prescription products.  Prescription products are being marketed through more controlled, non-interactive strategies using conventional Internet outlets, such as fixed websites, and links to and from websites – which, by today’s standards, are antiquated avenues for advertising.  Accordingly, FDA-regulated industries have yet to harness the potential of social media.

FDA’S EMERGING SOCIAL MEDIA POLICY

FDA regulations require promotional messages to be truthful, non-misleading, and fairly balanced between the benefits and risks associated with a particular product.  When these regulations are applied to promotional activity on the Internet, determining what is promotional and how to apply the regulations can be challenging.

For instance, FDA held public hearings on Internet advertising and promotion in 1996,^[5] but then failed to issue any guidelines and subsequently halted all such work, presumably because the agency was not ready or prepared to act.  In 1999, FDA further delayed taking a position by informing the industry that it would “look at [Internet] issues on a case-by-case basis” while reserving the right to revaluate the need for regulations in the future.^[6] As a result, to glean FDA’s Internet policy, the industry has been forced to scrutinize individual enforcement actions against companies who have created and used Internet websites for improper promotion of their products.^[7]

In many ways, these Internet cases are similar to more traditional advertising cases in that the website owner had control of the content, its display, and access to it.  In 2008, FDA issued a Warning Letter concerning a YouTube video advertisement, but the fact the video was posted on YouTube was irrelevant; the Warning Letter would have been the same had the video been broadcast in a promotional conference hall.  There are some exceptions, however.

A few Internet cases highlight challenges that are particular to the Internet, such as determining when a link from page to page or from website to website is a continuation of the advertising and, thus, also subject to the many regulatory content requirements and restrictions.  Over the past few years, for example, the industry had developed a theory commonly referred to as the “one-click” rule under which FDA’s requirement to provide comprehensive product information, including safety information, in promotional material can be satisfied if such information is directly accessible from a link in the original promotional piece (i.e., no more than one-click away).

This rule was placed into question when FDA issued enforcement letters to 14 companies in 2009 concerning Google banner advertisements for their failure to include risk information in the banners.[8] The letters first revealed the Agency’s new thinking on the matter, and sent shock waves throughout the industry, causing many companies to reassess their internet marketing strategies.  FDA subsequently disavowed the industry’s interpretation of its past enforcement actions stating that FDA “never had what some are referring to as a ‘one-click rule.’”[9]

RECENT DEVELOPMENTS

Like a giant awakening from a 100 year nap, FDA has renewed its interest in addressing Internet communications and only recently acknowledged the special nature of the Internet as a marketing tool and venue.  The Agency held a public hearing in November 2009 and solicited written comments through a public docket that was open from September 2009 to February 2010.  These actions are intended to help the Agency determine how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the Internet and newer technologies.[10]

FDA has made the issuance of a policy on social media a priority for 2010.  According to FDA’s yearly agenda listing upcoming guidance documents, FDA plans to address the issues raised during the November public hearing and in the written comments through a guidance document, and may propose regulations, as encouraged by many participants at the hearing and in written comments.[11] Below is a summary of some of the issues FDA may address in a guidance document or rulemaking and suggestions for mitigating risk of an FDA enforcement action before FDA announces its position.

• Internet Growth and Control: The Internet is growing exponentially and the industry cannot monitor every Internet website or communication.  The industry does not want to be held responsible for content that it does not generate or encourage, but understands that it may be responsible for some social media communications depending on the amount of control it has to influence content and the type of media itself.

• Transparency: FDA and industry must work together to ensure consumers have access to accurate and truthful information about FDA-regulated products by making it easier for consumers to distinguish between third-party and company controlled website content.

• Space Limitations: The industry wants FDA to account for the evolving nature of social media and space constraints.  Guidelines or regulations regarding dissemination of risk information should be principal based and applicable to multiple social media formats.  Despite FDA’s position on the one-click rule, many in the industry are calling for FDA to formally adopt the rule and allow a company to present a brief introduction of its product (e.g., an abbreviated reference to the product’s indication and its most significant risks) based on the space constraints of the social media itself, provided there is easy access to full product information through a hyperlink.

• Third Party Social Media: By participating in an online discussion through social media (e.g., real-time chat room), the industry is concerned that it may be held responsible for any statements made during the discussion, even by unrelated third parties.  The industry is calling for FDA to permit companies to engage in online discussions without becoming responsible for all content, provided the communications are truthful, non-misleading, and in accordance any FDA standards for providing risk information through social media.  Many want FDA to provide them the freedom to determine whether and when to participate in or to correct information on third party sites.

• Off-Label Discussions: Given today’s regulatory environment where manufacturers are routinely held responsible for anything involving their products, there is trepidation that any off-label discussion or reference on an interactive social media site will impute knowledge and consent of an unapproved use to the manufacturer.  For company controlled websites, some have proposed requiring social media participants to agree to terms of use prohibiting off-label discussion.  A company could then monitor the website to ensure compliance with these terms, and, if necessary, take corrective action, which may include removing any off-label discussions.  Liability for off-label discussions may depend on the amount of control a company has over the social media environment itself.  Yet, even if FDA issues guidance addressing off-label concerns, enforcement decisions under the Food, Drug, and Cosmetic Act are not solely FDA’s province.  The Department of Justice (“DOJ”) represents FDA in formal enforcement actions and does not always agree with FDA; the DOJ has a history of scrutinizing conduct that appeared consistent with FDA guidance.

• Adverse Event Reporting: FDA’s MedWatch icon should be posted throughout the web to facilitate adverse event reporting.  Determining how to pursue incomplete adverse event reports disseminated through social media, and even whether certain social media formats themselves are appropriate contexts for the industry to investigate potential adverse events, remains unresolved.  Prior FDA guidance on adverse event reporting states that manufacturers should review any Internet sites they sponsor for adverse experience information, and are responsible for reviewing third party Internet sites only when they become aware of a potentially reportable issue on the site.[12]

• 2253 Submissions: FDA requires all prescription drug labeling and advertising to be submitted at the time of initial dissemination through an FDA Form 2253.[13] Because some social media communications (e.g., real-time chat room discussions) are, in many regards, analogous to those taking place between company sales representatives and healthcare professionals or patients, many in the industry believe the Form 2253 reporting requirement for social media should be limited to some extent.  FDA may decide to requiring companies to submit only the static elements of social media environments controlled by a company and promotional postings on social media controlled by third parties.

MITIGATING RISK

• Until FDA issues formal guidelines or promulgates new regulations governing Internet communications, you must assume that FDA will review any social media communications through existing FDA regulations.

• Develop policies governing employee use of social media.

• Closely monitor and enforce these policies.  FDA has stated that it is a “good idea” for companies to have a “robust policy in place for any type of promotion about their products, including social media.”[14]

• Closely track FDA warning and untitled letters to avoid the mistakes your peers make when they communicate through social media.

• Participate in all FDA meetings and provide FDA with information when requested.

• Pay attention.  FDA’s Internet policy may emerge quickly over the next two years.  There will likely be an opportunity to respond to draft guidance documents, FDA/industry hearings, and draft regulations.

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About the Authors

Areta Kupchyk is a partner at Reed Smith. She is a member of the Life Sciences Health Industry Group, practicing in the area of health care regulatory law.

Areta’s practice focuses on FDA regulatory issues.  Areta counsels on drug, device, biologics, and biotechnology matters.  Her experience includes product application, human cellular and tissue product regulation, pharmacogenomics and drug codevelopment with in vitro diagnostics (IVDs), xenotransplantation, clinical trial, and fast track approvals and submissions.

Kevin Madagan is an Associate at Reed Smith. He is a member of the Life Sciences Health Industry Group, practicing in the area of health care regulatory law.  His practice encompasses a wide range of regulatory, litigation, corporate and contractual matters.

Kevin works with numerous health care entities, including, pharmaceutical companies, medical device manufacturers, pharmacies, and health care providers (e.g., hospitals, skilled nursing facilities, rehabilitation facilities).  In addition, Kevin has experience with FDA and USDA regulated food entities.

• [1] Manhattan Research, Cybercitizen Health v8.0, The State of eHealth:  Trends of Today’s eHealth Consumer, at 203 (2008), available at www.ahdionline.org/ca/ahdi-wa/news/articles/The_State_of_eHealth.pdf.
• [2] See generally, 21 U.S.C. §§ 331(a) and 352(a), (n), (q) and (r).
• [3] Since May 2004, Pfizer, Inc., Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties.  In September 2009, for example, Pfizer pleaded guilty to two felony counts of marketing the anti-inflammatory drug Bextra for unapproved uses and agreed to pay $1.19 billion (the largest criminal fine in U.S. history) and forfeit $105 million to the government.  Pfizer also agreed to pay $1 billion to resolve allegations under the False Claims Act that it illegally promoted Bextra and three other drugs and paid kickbacks to health care providers.  U.S. Department of Justice, Justice Department Announces Largest Health Care Fraud Settlement in Its History Pfizer to Pay $2.3 Billion for Fraudulent Marketing, at http://www.fbi.gov/pressrel/pressrel09/justice_090209.htm.  In January 2009, Eli Lilly & Co. pleaded guilty and paid $1.42 billion in fines and penalties to settle charges that it had illegally marketed Zyprexa, a drug approved for the treatment of schizophrenia.  U.S. Department of Justice, US v. Eli Lilly and Company (Zyprexa), at http://www.justice.gov/civil/ocl/cases/Cases/Eli_Lilly.  In September 2007, Bristol-Myers paid $515 million — without admitting or denying wrongdoing — to resolve allegations of illegal drug marketing and pricing.  U.S. Department of Justice, Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing, September 28, 2007, at http://www.justice.gov/opa/pr/2007/September/07_civ_782.html.
• [4] 21 U.S.C. § 333(a)(1)-(2).
• [5] See FDA, Promotion of FDA-Regulated Medical Products on the Internet, Notice of Public Meeting, 61 Fed. Reg. 48,707 (Sept. 16, 1996).
• [6] See The Pink Sheet (November 8, 1999) pg. 22 (Statement of Melissa Moncavage, DDMAC Public Health Advisor, at Drug Information Association conference on October 23, 1999); see also DDMAC, Center for Drug Evaluation and Research presentation by Melissa Moncavage on November 3, 1999, at www.fda.gov/cder/ddmac/diammm1999/tsld003.htm.
• [7] For example, in November 2009, FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 websites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers.  As part of this investigation, FDA issued 22 warning letters to the operators of these websites and notified Internet service providers and domain name registrars that the websites were selling products in violation of U.S. law.  FDA, FDA Issues 22 Warning Letters to Web site Operators – Part of International Internet Week of Action, at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191330.htm.
• [8] On April 3, 2009, FDA issued untitled letters to (1) Bayer Healthcare Pharmaceuticals, Inc.; (2) Biogen Idec; (3) Boehringer Ingelheim Pharmaceuticals, Inc.; (4) Cephalon, Inc.; (5) Eli Lilly and Co.; (6) Forest Laboratories, Inc.; (7) Genentech, Inc.; (8) GlaxoSmithKline; (9) Hoffman-LaRoche, Inc.; (10) Johnson & Johnson Pharmaceutical Services LLC; (11) Merck & Co., Inc.; (12) Novartis Pharmaceuticals Corp.; (13) Pfizer, Inc.; and (14) Sanofi Aventis, U.S. LLC. See e.g., FDA Untitled Letter to Pfizer, Inc., at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM143487.pdf
• [9] FDA Response to Ignite Health FDA Social Media, Questions for the FDA Regarding ‘Next Steps’ for Guidance Related to the Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools, Dec. 11, 2009,  www.fdasm.com/docs/FINAL%20DDMAC%20Responses%20to%20FDASM_Questions.pdf.
• [10] See 74 Fed. Reg. 48083 (Sept. 21, 2009).
• [11] FDA, Guidance Agenda:  New Draft Guidances CDER is Planning to Publish During Calendar Year 2010, available at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079647.pdf.
• [12] FDA, Post-Approval Safety Data Management:  Definitions and Standards for Expediting Reporting, ICH Harmonized Tripartite Guideline draft (July 18, 2003), available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm129457.htm.
• [13] 21 C.F.R. § 314.81 (b)(3)(i).
• [14] FDA, supra note 9.

About the Author
Areta Kupchyk is a partner with Nixon Peabody LLP who provides counsel to clients on the U.S. Food and Drug Administration (FDA) regulation of drug, medical device, biotechnology, and biologic products. Formerly an Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation at the FDA, Ms. Kupchyk possesses a nuanced understanding of FDA regulatory procedure that allows her to insightfully navigate clients through all phases of product development, review, and approval, including obtaining approvals with market protections such as three-year market exclusivity for new indications requiring clinical studies, five-year market exclusivity for new chemical entities, and seven-year market exclusivity for orphan drugs.