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 According to an NPR investigation, the FDA has withdrawn at least 28 accelerated approvals, with the process taking an average of more than seven years.
But at a time when many people are expressing doubt in science and the safety of vaccines, and when another vanguard of public health, the U.S. Centers for Disease Control and Prevention, has recently acknowledged its own deficiencies in managing the Covid-19 pandemic, I worry that the FDA’s actions risk sowing further mistrust in medicine and public health. Not because it’s wrong to pull a drug from the market when warranted — that’s absolutely the right thing to do — but because the FDA hasn’t adequately communicated that withdrawing approval is in the public’s best interest.
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