The US Food and Drug Administration’s accelerated approval withdrawal hearing for Covis Pharma’s preterm birth drug Makena highlighted a regulatory gap – as the FDA slowly completes the steps required to pull a medication from market, a company can promote the product as it sees fit, no mention of the drug’s perilous approval status required.
The House-passed accelerated approval reform bill, cleared as part of FDA’s broader user fee renewal package in June, included new labeling requirements for accelerated approval drugs to try and make...