Opinion: What the Makena vote means about accelerated approval, trust, and the FDA
On Wednesday, the FDA advisory committee that oversees obstetrics, reproductive, and urologic drugs voted 14-1 that the drug Makena was not effective at reducing the risk of preterm birth, and that it should be removed from the market.
We’ve been here before. In 2011, the same year that Makena received accelerated approval from the FDA, I was a member of a similar FDA advisory committee hearing in which we considered withdrawing the breast cancer indication for the drug Avastin. According to an NPR investigation, the FDA has withdrawn at least 28 accelerated approvals, with the process taking an average of more than seven years.
