OxyContin Decision Involved FDA ‘Miscalculation,’ Woodcock Says

A top FDA official who oversaw the approval of Purdue Pharma‘s OxyContin said Wednesday that the agency failed to adequately predict the harms associated with the drug that has fallen into the center of the US opioid epidemic.

Janet Woodcock, now the Food and Drug Administration’s principal deputy commissioner, said in remarks at the Food and Drug Law Institute’s annual conference that there was a “miscalculation about projected harms” of the opioid painkiller, which the agency first approved in 1995 when Woodcock served as the director of the Center for Drug Evaluation and Research.

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