Plan B Decision May Offer FDA Best Political Protection Available
Assuming that sexually charged products such as Teva’s emergency contraceptive remain subject to political decision-making, the explicit heavy hand of the HHS secretary in the OTC switch ruling may be the best approach for FDA and the Rx industry, especially considering the alternatives.
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As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.
Emily Miller, who joined FDA a few days before its controversial roll out of emergency use authorization for convalescent plasma, remains at the agency. Situation shows importance of sticking to science-based decisions, former FDA officials say.
Outgoing US FDA Office of New Drugs director tells the Pink Sheet being on the outside will take some adjustment.