Tired Of Winning? When It Comes To US FDA Appeals, “Denied” Can Still Mean Victory

Success rate for sponsors pursuing appeals of FDA rejections is much higher than reported by agency, a leading US regulatory law firm argues. Agile Therapeutics’ “loss” of an appeal is a good example of how sponsors can still benefit even if their formal request is denied.

Agile Therapeutics Inc.’s Oct. 9 press release sure sounds like bad news: The US FDA’s Office of New Drugs “has formally denied the Company’s appeal” of the most recent rejection of Agile’s Twirla contraceptive patch.

The company’s appeal had already being denied by the Office of Drug Evaluation III, which initially considered the dispute resolution...

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