FDA executes a 180 on TherapeuticsMD therapy, handing it an OK — and stoking concerns about political influence
A year after the FDA handed TherapeuticsMD $TXMD a rejection letter for its therapy preventing vaginal pain during sex, the agency has done a complete 180 — approving the treatment after waving off the safety concerns that had once warranted a CRL.
The decision to drop the CRL and allow the application to proceed without meeting specified hurdles is one of three the FDA executed in the weeks after Scott Gottlieb jumped into the top job at the FDA, raising concerns that political influence was changing the fortunes of some of the companies with business before the agency. In this case, Gottlieb — handed a mandate to speed approvals — won the nomination the day after the rejection was announced by TherapeuticsMD.
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