Janet Woodcock presided over one of the worst regulatory agency failures in U.S. history. She ran FDA’s drug division in 1995, when OxyContin was first approved, and she has been there for all of the FDA’s disastrous opioid decisions.
By the early 2000s, when it became clear that OxyContin was devastating communities in Appalachia and New England and when it became clear that prescribing was taking off at a rate much greater than could be clinically needed, FDA could have taken steps to bring the problem under control. FDA could have narrowed the indication on the label. But it didn’t narrow the indication. Instead, labels were changed to make it easier to market long-term use. And, making things even worse, FDA changed the rules for approving new opioids, making it easier for drug companies to put new opioids on the market, at times, even over the objection of FDA’s own scientific advisors. In 2015, FDA gave Purdue permission to market OxyContin for use in children as young as 11 years old. And more recently, FDA approved a new fentanyl analogue that is 1000 times more potent than morphine.