The U.S. Food and Drug Administration (FDA) released today two highly anticipated draft guidance documents:
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; and
- Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.
These guidance documents are in response to significant industry pressure for clarity on social media promotion, as well as public hearings titled, “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools”, held by the FDA in November 2009 regarding promotion of pharmaceuticals and medical devices using the internet and social media. Another draft guidance document related to social media also was released by the FDA earlier this year.
Cooley intends to post additional, more detailed information about these draft guidance documents shortly. Pharmaceutical and medical device manufacturers should carefully review them and consider whether to submit comments to the FDA. Interested parties have 90 days to submit comments, which can be submitted electronically at http://www.regulations.gov.