Crawford assumed Plan B decision-making power

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Features

Email Newsletters


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?