On November 12-13, FDA formally will begin contemplating redefining its promotion rules in the wake of the evolution of new technologies at a two-day public hearing in Washington, D.C. The agency's drug, biologic, device and veterinary medicine centers will participate in this public hearing, and FDA is seeking input from all interested parties, including consumers, patients, health care professionals, Internet vendors, advertising agencies and the regulated industry. In scheduling this hearing, FDA has acknowledged that while its existing rules and guidance may sufficiently address promotional issues raised by the Internet and social media, new technologies and media tools may raise unique issues (e.g., real time communication and space limitations) for which industry lacks direction as to the application of existing rules and guidance. Namely, these new technologies and media may require FDA provision of additional guidance to industry on the compliant use of these new promotional tools. The public hearing will cover a wide range of issues for which online communications manufacturers, packers or distributors are responsible:

  • how to ensure a fair and balanced presentation of product information in new social media and Internet tools;  
  • the role (if any) that companies should play in correcting misinformation regarding their products posted on third-party websites;  
  • the use of links to third-party informational websites which may contain off-label information; and  
  • the receipt, review and processing of adverse event information available on social media sites.  

To date, the only Internet-related "guidance" that companies have received has come in the form of various warning letters to industry about activities or information presentations FDA has found violative of its rules. This approach has bred fear within the industry of becoming a test-case for the agency's application of its existing rules and guidance to innovative promotional methods. The lack of guidance on the application of FDA's rules to new promotional tools perhaps became most evident earlier this year, when the agency issued 14 warning letters on the same day for companysponsored links featured in one- or two-line advertisements that failed to include any risk information. As the public hearing is a sign that FDA likely will prepare draft guidance for industry on Internet and social media promotion, the public hearing may likewise signal some temporary breathing room for industry with respect to the promotional use of these communication tools. Written and electronic comments will be accepted until February 28, 2010.