FDA's Social Media Enforcement: Emerging Rules of Engagement

The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have signaled that social media marketing is a priority. In 2009, FDA held a public meeting [2] on social media. FDA requested comments social media issues, including communicating risk information, use of links, and adverse event (AE) reporting. In 2010, FTC issued revised Endorsement & Testimonials Guides [3] addressing social media marketing and Behavioral Marketing Principles [4] describing confidentiality, disclosure, and other considerations for targeted, personalized consumer marketing. This year, FTC issued its draft Privacy Report [5] describing a compliance framework for protecting online consumer data collected, shared, or maintained by commercial entities.

Since 2009, hundreds of articles, conferences, and webinars have addressed the risks and challenges of marketing prescription drugs and other FDA-regulated products in social media. While the risks, challenges, and potential pitfalls of social media marketing are evident, the rules are not as clear. Current labeling and advertising laws provide helpful guidelines, but do not address the interactivity, mobility, social networking, and speed of communications that make social media an effective tool for marketing and consumer research.

As a result, most pharmaceutical companies have shied away from social media marketing. Further, although FDA has not issued formal social media guidelines, it is actively conducting social media surveillance and enforcement. This article describes FDA and FTC’s social media jurisdiction, FDA enforcement trends, and emerging rules of engagement.

FDA and FTC jurisdiction

FDA regulates the marketing and distribution of pharmaceutical products, along with other regulatory agencies such as FTC. FDA prescribes the format and content of labeling for prescription drugs and other FDA-regulated products, as well as prescription drug advertising. FTC regulates the advertising of over-the-counter (OTC) drugs, medical devices, and other FDA-regulated products. “Labeling” includes package labels and other printed or graphic matter on or attached to the product, as well as materials distributed by the manufacturer or marketer as part of an integrated marketing plan, even if such materials do not physically accompany the product.

FDA regulations prescribe specific requirements for product labeling that may not apply to advertising, but in many cases the difference between labeling and advertising is semantic as many forms of advertising also fit within the definition of labeling. The key point is that manufacturer-generated social media content that describes or promotes a product likely will be considered labeling or advertising. FDA and FTC therefore review social media content to ensure that product messages are accurate and non-misleading and that such messages comply with other applicable legal and regulatory requirements.

In most cases, product labeling and advertising rules are fairly straightforward, but jurisdictional and regulatory boundaries can be murky when FDA and FTC use manufacturer statements and activities, third-party content, and product-related messages for evidentiary purposes. For example, FDA has historically relied on company press releases, testimonials, and other company statements to establish a product’s “intended use”, the elements of a statutory violation, or intent. Thus, social media content that ordinarily would not be subject to labeling or advertising requirements, could become evidence of off-label promotion or other violations if used in a promotional context. The threat of enforcement based on such statements has lead many companies to restrict corporate outreach and communications to patients and healthcare providers.

Companies may find it more difficult to maintain the same degree of control over corporate communications and outreach in social media because users, employees, competitors, consumer groups and others have the ability to access, share, critique, and sometimes alter company messages without the company’s knowledge or approval. Self-policing is also difficult if employees discuss products or services on personal networking sites, such as cafepharma.com, promote products without disclosing their connection to the company, or disclose confidential company information.

Google Sidewiki is a good example. Sidewiki is a browser sidebar that allows Google account-holders to contribute to and read information alongside a web page. Some pharmaceutical companies have attempted to address user-generated content on Sidewiki by including disclaimers, which state that they are not responsible for third-party comments and do not monitor or respond to such comments. This approach appears to be consistent with FTC and Securities and Exchange Commission (SEC) guidelines, which state that companies are not responsible for third-party posts on company-sponsored sites or blogs, and that companies are not obligated to correct third-party misstatements, unless the company adopts the statement for promotional or other purposes.

This model is also reflected in a draft AE guidance issued by the International Conference on Harmonization (ICH) [6], which states that companies are not required to monitor third-party cites of AEs, but must monitor their own websites and address AEs on third-party sites if they become aware of them. FDA has yet to provide concrete guidance on these issues. Thus, it remains to be seen whether disclaiming responsibility or knowledge of user-generated content on or about company-sponsored sites will suffice, particularly if adverse events are reported or discussed in these forums.

FDA surveillance and enforcement

For the past four years, FDA’s Division of Drug Marketing and Communications (DDMAC) has issued Warning Letters based on social media content. The letters generally focus on three topics: (1) off-label promotion; (2) failure to comply with “fair/balance” requirements in presenting drug benefits and risks, and (3) manufacturer responsibility for user-generated and third-party content. The letters show that FDA is applying existing prescription drug marketing rules and principles to social media content.

In March 2009, FDA set off a flurry of activity and interest in social media by sending untitled letters [7] to 14 pharmaceutical companies that had sponsored link advertisements for drug products on internet search engines. FDA alleged the links, which typically contained the drug name and its indications for use, were misleading for one or more of the following reasons: omission of risk information, overstatement of efficacy; inadequate communication of indications; failure to use the required established name for specified drug products. Despite the fact that links to risk information on the branded product websites were provided, FDA found the links “insufficient to mitigate the misleading omission of risk information” from the sponsored links. The letters resulted in a dramatic decline in branded sponsored links and an increase in the number of sponsored links for unbranded, disease awareness websites.

Warning Letters in April and July 2010 addressed the use of unbranded disease awareness websites and third-party content. In an April 2010 letter [8], FDA asserted that information on unbranded company-sponsored disease awareness websites and third-party sites contained misleading statements, unsubstantiated superiority claims, and off-label statements. Although the websites did not identify the brand name or established name of any drug products, FDA stated that the company was responsible for the content on the third-party cites, because the cites mentioned the company by name and FDA determined that websites were registered by the company.

In the July 2010 Warning Letter [9], FDA noted that a claim on a branded website contained a link to an article on a particular therapy. FDA noted that when the link is presented on a branded product page with videos and other messages promoting the drug, the claim suggests that the drug is effective for the therapeutic uses described in the linked article.

Another 2010 Warning Letter [10] concerned a Facebook Share widget on a branded website. FDA stated that the product was misbranded because the shared content available from company and user-generated web pages failed to communicate risk information. Facebook Share allows Facebook users to share content on a website with other Facebook users by generating a link to the page, along with a thumbnail image and a brief description that will appear on the users’ profiles or home page. Each time a link is shared by one user, potentially hundreds of new people may see and/or access the link. Although the shared content contained links to a branded product website that contained risk information, FDA found that the link was insufficient to address the absence of risk information in the shared content. FDA also noted that shared content on several sites contained unsubstantiated superiority claims and claims that broadened the drug’s indication. FDA further cited the company for failing to submit samples of the shared content in a Form FDA-2253, as required by the prescription drug regulations.

While the laws, regulations, and principles stated in Warning Letters are undoubtedly familiar to most pharmaceutical companies, FDA’s nuanced interpretations and applications of these concepts to various forms of social media provide new and sometimes unexpected insights on the likely direction of regulation and enforcement.

Emerging rules of engagement

In the absence of specific guidance from FDA, what social media guidelines should companies consider when engaging in social media?

First, companies should establish social media policies or amend existing policies to address social media issues. In creating guidelines, a company should: (1) clarify its goals and objectives; (2) identify topics for which proactive engagement will be useful for the business; (3) determine which department or multi-disciplinary functions will be responsible; and (4) establish guidelines for employee participation in social media that distinguish between personal use of social media and authorized postings on behalf of the company.

Second, because companies are responsible for content they create, own, or control, social media policies should contain parameters for disseminating company-generated content in social media. The policies should address issues such as, the use of paid or authorized testimonials, celebrity endorsements or “tweets”, and authorized product placements in blogs or Twitter. If companies invite consumers to communicate with them via their branded or corporate websites, the company policy should also address whether the company will disable comments to prevent off label content or filter such comments. Companies should also consider the use of disclaimers or notices clarifying whether or when they plan to monitor or respond to user-generated content. Policies should also require employees to disclose their connection to the company when contributing authorized content on the company’s behalf.

Third, because manufacturers and marketers may be responsible for third-party content that they sponsor, adopt, or endorse, policies should address the use and/or sponsorship of third-party websites. As evidenced in recent Warning Letters, FDA’s surveillance includes activities designed to decipher complex corporate relationships, domain name registrations, and other financial relationships that link third-party websites, blogs, etc. to branded products and companies.

Fourth, pharmacovigilance policies should address AEs reported or discovered in social media. If a company decides to filter or screen objectionable user-generated content from company-sponsored blogs, websites, etc., the policy should address whether or to what extent the company will screen or monitor archived content for possible AE reports.

Fifth, social media policies should address the use of behavioral or personal marketing strategies. If companies receive, store, purchase, or track consumer online use or searches for targeted prescription drug marketing, policies should address ethical, legal, privacy and potential disclosure obligations in light of FTC guidelines.

Finally, despite FDA’s lack of clarity on social media engagement, pharmaceutical companies can effectively and appropriately engage in social media by applying practical, common-sense rules. Company activities and statements that ordinarily would not be allowed in traditional print or broadcast matter probably would not be permitted in social media. Where the rules are unclear, both the plain meaning and underlying purpose of existing laws or regulations should guide social media policies and strategies. PC

REFERENCES

1. The author would like to thank Arnold & Porter associate Jennifer Kang for her research and assistance in compiling the data and references for this piece.

2. http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm

3. http://www.ftc.gov/os/2009/10/091005revisedendorsementguides.pdf

4. http://business.ftc.gov/documents/po85400-self-regulatory-principles-online-behavioral-advertising

5. http://www.ftc.gov/opa/2010/12/privacyreport.shtm

6. www.fda.gov/RegulatoryInformation/Guidances/ucm129457.htm

7. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/

EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM055773

8. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/

ucm210191.htm

9. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/

ucm220286.htm

10. http://www.fda.gov/downloads/Drugs/

GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/

UCM221325.pdf

ABOUT THE AUTHOR

Vernessa Pollard, former Associate Chief Counsel in the US Food and Drug Administration’s Office of Chief Counsel, is a partner in Arnold & Porter LLP’s FDA and Healthcare Practice in Washington. During her tenure at the agency from 2002 to 2008, Ms. Pollard represented the FDA in a variety of major litigation matters, and advised agency clients on compliance and regulatory issues involving drugs, medical devices, dietary supplements, cosmetics, pharmacy compounding, good manufacturing practices (GMP), Congressional inquiries and disclosure of records under the Freedom of Information Act.