Janet Woodcock on the lessons of that whole Sarepta situation

It has been nearly three years since the public debate, private bickering, and industry-wide consternation that came with the FDA's decision to approve a Duchenne muscular dystrophy treatment from Sarepta Therapeutics. And Janet Woodcock, the FDA official at the center of that story, said the agency has come a long way since then.

Speaking to STAT's Ed Silverman, Woodcock called the Sarepta story "an extreme example," adding that "you don’t want controversy or hullabaloo over a drug approval decision."

But it also motivated the agency to work more closely with patients. "We’ve developed a more outward-facing approach to neuroscience and responding to communities," she said. "We want to have a patient focus in drug development meetings to collect information."

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