Janet Woodcock, the top drug evaluator at the FDA, was the driving force behind the FDA’s recent decision to approve eteplirsen (Exondys 51), a drug for patients with Duchenne muscular dystrophy from Cambridge, MA-based Sarepta Pharmaceuticals (NASDAQ: SRPT).
The decision was controversial: Many FDA scientists didn’t want to approve eteplirsen. They didn’t want to lower the bar for future drug approvals—eteplirsen was approved mainly on data from a flawed study of just a dozen patients—and indicate to drug companies that the agency can be swayed by political pressure and lobbying from patient advocates. But they were overruled by Woodcock, who has been a proponent of increasing patients’ input in the current drug evaluation process. Read the full story here.