The comments are in! As usual, the pharma industry waited until the last minute to submit comments to FDA Docket 2013-N-1430 regarding "Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics."
This article provides highlights from submissions by Novartis, Shire, the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country's leading pharmaceutical research and biotechnology companies, the Biotechnology Industry Organization (BIO), Klick Health, the Social Media Compliance Council (SMCC), the Coalition for Healthcare Communication (CHC), and the Digital Health Coalition (DHC), and other interested parties.
Topics include (partial list)
Download the full text PDF file here:
- Links to All Comments
- Figure: Focus of Comments Submitted
- What Constitutes "Influence?"
- FDA vs. "Journalism Ethics"
- Scope of Control Over 3rd Party Sites
- Off-Label Adjacency
- PhRMA Questions Legality
- Impact on Earned Media Coverage
- Burdensome Paperwork!
- User-Generated Content
- To Moderate or Not Moderate?
- Employee-Generated Content
- A Social Media "Laboratory"
- Possible Real-World Scenarios
- FDA Intern: The Quest for Social Media Guidelines
- What About Pre-Approval Social Media?