Today and tomorrow, November 12-13, the FDA is holding a historic public hearing regarding the “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.” This is the first time since 1996 that the FDA has examined the role of technology in pharmaceutical and medical device communication and advertising.
The FDA is looking at five questions, as stated in the Federal Register notice about the hearing:
- “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, postmarketing 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.”