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A Food and Drug Administration advisory committee in a rare move on Wednesday voted 14-1 to pull the only available drug aimed at lowering the risk of premature births from the market, citing a lack of evidence that the medication shows any benefit.
The Obstetrics, Reproductive and Urologic Drugs Advisory Committee’s recommendation is nonbinding, and FDA Commissioner Robert Califf will make the final decision in conjunction with Chief Scientist Namandjé Bumpus. But the agency typically follows the advice of its advisory committees, and top FDA officials argued forcefully against the drug, Makena, in presentations earlier this week.
The drugmaker’s attempts to find benefit in the data ultimately failed to persuade the committee. Members voting against the drug included Annie Ellis, a patient representative who emotionally recounted her own experience with risk of preterm birth, including crawling out of bed against her doctor’s orders to care for her three-year-old.
“Sometimes when I see a lot of mathematical gymnastics being used to cut things in different ways and try to squeeze out a subset that has benefits, I have concerns,” she said, adding that she had to vote with her head rather than her heart.
Cassandra Henderson, a maternal medicine consultant with Rockwood Partners DPP, was the lone yes vote, noting the company’s initial trial showed some benefit and expressing concern that compounding pharmacies, which adapt drugs that are not commercially available and are largely outside of the FDA’s purview, would continue to offer riskier versions of the drug.
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