The U.S. Food and Drug Administration (FDA) has issued a notice of public hearing and request for comments to discuss issues surrounding the use of the Internet and new social media tools (e.g., blogs, podcasts, social network sites, video sharing, widgets, and wikis), in the promotion of medical devices, prescription drugs, prescription biologics, and prescription animal drugs. The public hearing is scheduled for November 12 and 13, 2009, in Washington, D.C.
The announcement of the November public hearing came on the first day of the Food & Drug Law Institute’s 21st Annual Advertising and Promotion Conference, where FDA leadership relayed a general message of strict and vigorous enforcement when it comes to advertising and promotion compliance. The new and quickly evolving social media tools were highlighted as an area that has raised questions and concerns on the part of the agency, as well as industry, in terms of the application of existing laws, regulations, and policies. The FDA, to date, has not issued specific regulations or guidance on Internet promotion, despite industry’s continued request for more specific guidance over the years. 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 in the realm of enforcement actions.
FDA is seeking participation and input from all interested parties to help guide the agency in making policy decisions on the promotion of FDA-regulated products using the Internet and new social media tools. Participants have been invited to comment on any aspect of Internet promotion generally. However, FDA has also identified the following five categories for discussion at the November public hearing — categories that encompass specific types of issues that have been frequently raised by regulated companies and other interested parties:
- For what online communications are manufacturers, packers, or distributors accountable?
- How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, post-marketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?
- What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
- When is the use of links appropriate?
- Questions specific to Internet adverse event reporting.
Within each of the above categories, the FDA has identified specific questions and concerns for which it is seeking input. We encourage medical device companies to review the Federal Register notice, consider participating in the public hearing, or submitting comments to the docket. To submit comments or register to attend or speak at the public hearing, please refer to Docket No. FDA-2009-N-0441 at www.regulations.gov. The FDA is accepting comments through February 28, 2010.
The regulation of Internet and social media promotion will continue to present considerable challenges for the FDA and industry, particularly in light of the pace at which new media tools are evolving and the complexities of developing a flexible framework that can accommodate a range of promotional tools. In that regard, it will be important for companies to stay abreast of FDA’s continuing efforts and to periodically review internal promotional policies and activities.