CDER’s Galson Cites Application Flaws, Not Politics, In Plan B Decision
This article was originally published in The Tan Sheet
Barr Labs submitted a marketing plan for behind-the-counter sale of Plan B (levonorgestrel .75 mg), but FDA was "unable" to review the package
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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.
An FDA decision on OTC availability of Barr Labs' Plan B emergency contraceptive is expected by the end of January
An amendment intended to support the over-the-counter switch of emergency contraceptive Plan B (levonorgestrel) survived debate on the House floor July 13