FDAer Resigns Over Plan B; Senators Seek Results Of GAO Investigation
This article was originally published in The Tan Sheet
FDA Office of Women's Health Director Susan Wood is resigning over the agency's handling of Barr Labs' application to switch its Plan B emergency contraceptive over-the-counter
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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.
Perpetual political lightning rod - and emergency contraceptive - Plan B has another chance to draw strikes to FDA as the agency has chosen to comply with a court ruling ordering it to reconsider whether the drug should be available in a truly over-the counter setting
The court ruling overturning FDA's restricted distribution of the emergency contraceptive Plan B could have a number of implications for the biopharma industry - ranging from a near-term impact on confirmation of Obama administration nominees to a longer-term curbing of creative product risk management activities