FDA has long grappled with the thorny issue of the distribution of off-label
drug information to physicians by the pharmaceutical industry and has published several draft, final, and revised final guidances related to that issue. The pharma industry and its allies have challenged the FDA's policies at every stage and fought legal battles in court to defend the right to distribute off-label, but scientifically sound drug information to physicians.
On June 6, 2014, FDA issued a THIRD guidance document regarding reprint distribution by pharmaceutic companies: "Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products - Recommended Practices." This new document describes FDA's recommendations for distributing reprints that convey "new risk information" for approved drugs.
Topics include (partial list)
Download the full text PDF file here:
- Some Off-Label Litigation History
- A String of Off-Label Guidances
- WLF vs FDA
- Criteria of Approved Off-Label Studies
- Sidney Wolfe Cries Foul!