FDA Publishes First Piece of Long-Awaited Social Media Guidance Focus is on Accountability
On January 14, 2014, the FDA published “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” in the Federal Register (Docket No. FDA-2013-N-1430).
Although the guidance is focused on when and how pharma companies should submit forms to the FDA to fulfill regulatory requirements for postmarketing submissions, it does offer some insights regarding FDA’s thinking on regulating “interactive media.”
Pundits pondered: Was this the much-anticipated guidance for how the FDA will regulate drug promotion on the Internet and social media sites?
The answer is “Yes.” A Public Affairs Specialist at FDA’s Center for Drug Evaluation and Research (CDER) confirmed to several reporters that this guidance is actually PART of the long-awaited guidance that was promised after the November, 2009 public hearing and required by section 1121 of the Prescription Drug User Fee Act (PDUFA).
Topics include (partial list):
- Postmarketing Submission Requirements
- Internet Poses Problems for Timely Submission
- Focus on Accountability
- User-Generated Content, e.g. Wikipedia
- Promotional Content on Third-Party Sites
- Comments from Drug Industry
- What Does This Mean for DTC Marketers?
- When and How to Report
- What’s Next?
Download the full text PDF file here:
Issue: Vol. 13, No. 1: January 2014