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The U.S. Food and Drug Administration commissioner would like to get rid of voting at the end of advisory committee meetings “as much as possible,” STAT reports. “The most important thing to me about the advisory committees is that the purpose is not to take a vote on the approval of a product,” says FDA Commissioner Robert Califf. The voting is “a habit, it’s not a requirement, and it’s not very useful. I’d like more advisory committees to be about the thinking about the field and the intervention that’s being assessed, not so much the approval decision. That’s an FDA decision, not an advisory committee decision.”
After months of anticipation, the manufacturer of a controversial drug for premature births agreed to withdraw its treatment, capping an unusual battle with the FDA over its authority to have medicines removed from the market, STAT tells us. The drug in question, called Makena, was approved more than a decade ago and quickly generated a firestorm over its cost. More recently, though, its effectiveness was thrown into doubt after results of a required follow-up clinical trial failed to verify a benefit. But the company that sells the treatment, Covis Pharma, fought a request by the FDA to withdraw the drug.
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