After years of refusing to craft Internet-specific policies, the FDA did an abrupt about-face today by announcing a public hearing on the matter.
In a Sept. 21 notice in the Federal Register, the agency detailed plans for a public hearing Nov. 12 and 13 in Washington, D.C. The hearing will "help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools," according to the notice.
During a presentation at a Food and Drug Law Institute-sponsored conference Monday morning, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, explained that the agency’s goal is to "eventually issue a draft guidance" on the matter.
The announcement follows years of industry complaints about the lack of guidance in the online realm. Those complaints came to a head this spring when the agency crafted 14 Untitled Letters chastising companies for their handling of sponsored links online.
For additional coverage of the FDA initiative, see upcoming issues of the FDA Advertising and Promotion Manual newsletter.
September 21, 2009
Source: FDA.gov
No comments:
Post a Comment