New disclosures show that former FDA commissioner Lester Crawford took the unprecedented step of assuming all decision-making authority on the OTC Plan B emergency contraceptive, the issue that continues to block Senate consideration of his nominated successor, acting commissioner Andrew von Eschenbach.
Federal court depositions taken in April by the Center for Reproductive Rights from FDA deputy commissioner for operations Janet Woodcock and CDER director Steven Galson revealed the authority was transferred to Crawford in Jan. 2005.
The Center for Reproductive Rights is suing the FDA, seeking an order requiring it to make Plan B available without a prescription for women of all ages.
Seven months before that authority withdrawal, Galson claimed his earlier decision not to approve Plan B’s NDA for OTC sale was not “directed” by contacts he’d had from the Commissioner’s Office.
When Galson’s authority was removed, the FDA was already eight months into its new, post-NDA rejection review of how to regulate a product that would be OTC for females 16 years and up and Rx-only for anyone younger than 16. The submission still has not received a final FDA decision.
From the June 01, 2006 Issue of MM+M - Medical Marketing and Media
