FDA Holds Forum on Advertising and Promotion with Social Media Tools

On November 12-13, 2009, FDA held a public hearing to discuss issues surrounding the use of the Internet and social media tools (e.g., blogs, podcasts, social network sites, video sharing, widgets, and wikis), in the promotion of medical devices, prescription drugs, and prescription biologics.(1) More than 50 speakers presented information to FDA at the meeting, representing individual drug and device firms, industry trade groups, advocacy organizations, and social media outlets, as well as Internet research sites such as Google, Yahoo!, and WebMD.(2) 

The FDA, to date, has not issued specific regulations or guidance on Internet promotion, despite industry’s continued request for more specific guidance.  While many Internet promotion issues can adequately be addressed with existing laws and regulations, over the years, as technology has developed, policies specific to new media tools are routinely being developed by the agency for use in its enforcement actions.  For example, earlier this year, FDA sent warning letters to 14 major pharmaceutical companies noting that sponsored links, which arise in search engines in response to certain search terms, were misleading advertisements because they did not contain risk information.(3)

While FDA has shown a willingness to base enforcement actions on promotions using new Web-based tools, industry has been hesitant to participate in Internet-based advertising due to a lack of detailed guidance on the subject.(4)  While drug makers spent $4.4 billion on advertising in the past year, only $130 million of these funds were dedicated to Internet advertising.(5)  Meanwhile, consumer utilization of Web-based tools for health-related research continues to grow—as many as 4.6 billion searches on health keywords are conducted each year, and 61% of American adults now look online for health information.(6)  Representatives from Eli Lilly noted that by not providing guidance to industry, FDA produces uncertainty that keeps drug and device firms “on the sidelines” of this growing trend.(7)

In the notice of public hearing, FDA noted that the forum is part of an ongoing fact-finding campaign by the agency to determine whether to issue guidance regarding advertising and promotion using emerging Web-based technologies.(8)  The notice outlined a series of questions on which the agency is seeking input from interested parties, including when manufacturers should be held accountable for Internet communications, fulfilling regulatory requirements in light of social media tools that utilize character and space limitations, communications controlled by third parties, and the effect of Web-based tools on adverse event reporting.(9) 

At the hearing, most presentations focused on holding industry accountable for third party sites or communications regarding regulated products.(10)  Device-industry trade group AdvaMed noted that unauthorized third-party modifications to Internet content, for example, postings on wikis or other social media sites, are outside a company’s control, and companies should not be held accountable for such communications.(11)  Regarding adverse events, industry representatives and groups expressed their support for FDA’s adoption of international standards that require companies to monitor their own websites for adverse event reports, but do not require firms to screen external sites for such reports.(12)

Additionally, speakers discussed at length the problems presented by banner ads, sponsored links, or social media tools such as Twitter, which limit space such that presenting full risk information for a product is not feasible.(13)  Many speakers proposed a “one-click rule,” whereby these short ads would include a link to the product’s homepage, a mandatory, fixed warning, and finally a “more info” link to full risk information for the product, immediately following the fixed warning.(14)  Drug-industry trade group PhRMA proposed a similar approach.(15)

While most participants lauded FDA for holding the forum and addressing this important topic, there was no real closure from the meeting, as FDA representatives did not provide a clear perspective on the agency’s policies.(16)  Rather, the agency merely concluded the forum by noting that any forthcoming guidance or regulations would require time to develop.(17)