Bullseye On OTC Reproductive Drug Approvals In US After Federal Judge Questions FDA Expertise?

Attorneys comment to HBW about likelihoods of litigation to challenge FDA’s approval of OTC emergency contraceptive and of influence growing to affect agency’s consideration of NDA for OTC daily oral contraceptive.

A federal court ruling to stay the US Food and Drug Administration’s approval of abortion drug mifepristone likely will spur challenges to product approvals in categories across the agency’s oversight, with OTC emergency contraceptives potentially first on the list.

“I think if permitted to stand, the district court’s ruling could be destabilizing for drug development broadly,” said food and...