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The Food and Drug Administration's approval of Sarepta Therapeutics' experimental drug for Duchenne muscular dystrophy this year was one of the agency's most controversial decisions in recent history.
Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, says it was part of a broader move toward patient-focused drug development, something she says is encapsulated in the newly passed 21st Century Cures Act.
Woodcock, who approved Sarepta's drug against the wishes of others at the agency, also addresses the precedent set by the decision, as well as how much influence a new president can have on how the U.S. regulates drugs.