FDA to hold public hearing on online drug promotion

The FDA plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices using the internet and social media tools.

"The continually evolving nature of the Internet, including Web 2.0 and social media tools, as well as their expansion to applications such as mobile technology, have raised questions and concerns over how to apply existing regulations to promotion in these newer media," states the notice. "FDA is evaluating 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. Although the agency believes that many issues can be addressed through existing FDA regulations, special characteristics of Web 2.0 and other emerging technologies may require the agency to provide additional guidance to the industry on how the regulations should be applied."

The meeting, scheduled for 12–13 November in Washington (US), is a collaboration among the FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine(CVM), and the Center for Devices and Radiological Health (CDRH).

The FDA invites public participation, as well as written comments, on this issue to help in the decision-making process for policies that regulate online and social media promotions.

The agency held a similar public meeting in 1996 when the internet was becoming popular. Since that time, blogs, microblogs, podcasts, online communities, video-sharing, Wikis and more have emerged. Specific topics at the meeting will address, among other things:

• For what online communications are manufacturers, packers, or distributorsaccountable?
• How can manufacturers, packers, or distributors fulfill regulatoryrequirements?
• What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
• When is the use of links appropriate?
• And questions specific to internet adverse-event reporting.

Comments for the meeting can be submitted by 9 October 2009 and after the meeting until 28 February 2010 at www.regulations.gov. Registration information to attend the meeting is included in the full Federal Register notice.