FDA “Unable” To Decide On Plan B, Seeks Comment On Dual-Status Drugs
This article was originally published in The Tan Sheet
FDA believes additional information on whether a drug can be marketed both Rx and OTC for the same indication is needed before a decision can be reached on Barr Labs' switch application for Plan B
You may also be interested in...
It was only after prolonged litigation led a federal judge in 2013 to order FDA not to allow political interference with its science-based decisions that Plan B and generic equivalents became available OTC without age restrictions. “Hopefully, all I can say, it won't happen again,” says reproductive rights advocate Kirsten Moore.
The approval process for the over-the-counter sale of Barr's emergency contraceptive Plan B could be "wrapped up in a matter of weeks if [Barr and FDA] work diligently" together, according to an FDA spokesperson
The role of high-level FDA officials in the review of Barr Labs' Rx-to-OTC switch application for Plan B was required by the "high-profile" nature of the NDA, according to Center for Drug Evaluation & Research Director Steven Galson