FDA to Hold a Public Hearing on Internet, Social Media Marketing
BY LAUREN UZDIENSKI, SEPTEMBER 29, 2009
The FDA has announced plans to hold a two-day public hearing this November to gain feedback on the use of the internet and social media tools to promote drugs and devices. These platforms include YouTube, Wikipedia, Facebook, Twitter and any number of additional websites and services. Currently, there are no broad guidelines to govern online marketing, and the FDA has addressed web concerns on a case-by-case basis.
Back in April, 14 pharma companies received warning letters relating to their use of web promotion, despite the absence of any real guidance on the topic. This meeting reflects an effort to standardize web marketing regulations, and it's received a generally positive response from the industry. Pharma has been particularly vocal in favor of the initiative, with an unnamed pharma executive being quoted as saying, "It's about time . . . Any guidance at all is better than having no guidance, which is what we have right now."
At the hearing, the FDA will be considering the following questions:
1. For what online communications are manufacturers, packers, or distributors accountable?
2. How can manufacturers, packers, or distributors fulfill regulatory requirements?
3. What parameters should apply to the posting of corrective information on web sites controlled by third parties?
4. When is the use of links appropriate?
5. How does social media impact adverse-event reporting?
Comments can be submitted in advance of the hearing, which will be held on November 12-13, and will be accepted until February 29, 2010. The outcome of the meeting and comments should be draft guidance, according to CDER director Janet Woodcock.
