Professor Erika Lietzan was recently quoted by STAT regarding the Food & Drug Administration’s recent decision to grant accelerated approval to the first drug for Duchenne muscular dystrophy. The decision has attracted criticism, because approval was based on a single study in 12 patients and because scientists within the agency disagreed strongly.
Responding to suggestions that approval of the drug represented an unprecedented overreach by the FDA, Professor Lietzan explained that the approval actually fell well within the agency’s legal authority. She later listed several decades worth of precedent on Twitter. She tweets at @Lietzan.