The maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the United States
, though Covis has repeatedly appealed for more time to conduct additional research. The injectable drug has become a symbol for the challenges the FDA faces to withdraw a medication when the manufacturer won't do so voluntarily.
But the FDA made clear it would continue its process to force the drug’s removal on its own terms, according to the company. In a separate filing Wednesday, the agency's drug regulators recommended making the withdrawal “immediately effective.” The agency noted there's no indication of “harm from discontinuing Makena, such as signs or symptoms of withdrawal.”
Such hearings are extraordinarily rare and occur only after a drugmaker rejects initial FDA requests to pull its drug. About 10% of U.S. births come too early, before 37 weeks, raising the risk of serious health problems and even death in infants. The problem occurs at higher rates among Black women. Despite those results, reproductive specialists — including members of the American College of Obstetricians and Gynecologists — have argued for keeping the decade-old drug available while more research is done.
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