FDA Docs Reveal CDER Chief Skirted Procedures Approving Sarepta’s Controversial Drug Eteplirsen

While FDA commissioner Rob Califf was trying to navigate an internal civil war at the agency over its controversial decision to provide an accelerated approval for Sarepta’s eteplirsen, John Jenkins, then head of the Office of New Drugs, sent him a memo which detailed a blistering attack on CDER chief Janet Woodcock.

It was Woodcock who demanded, and won, the argument in favor of an accelerated OK of the Duchenne muscular dystrophy drug.