Expert advisers urge FDA to pull pregnancy drug from market

Peter Stein, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, acknowledged in closing arguments clinicians’ arguments about the need for an effective drug to reduce the incidence of preterm birth — a leading cause of infant mortality in the United States. He said the agency agrees with clinicians who testified during three days of hearings on the urgent need for such a drug, but only if the data and science support it — and that is not the case for Makena.

“Hope is a reason to keep looking for options that are effective, whether we find them here or elsewhere,” he said. “Hope is not a reason to take a drug that is not shown to be effective. or keep it on the market.”

The recommendations of the panel of independent advisers are nonbinding, though the agency usually follows its advice. Withdrawing a drug from the market is a highly unusual step.

The three day hearing was emotional both for members of the public, as well as the panel members of the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee.

Several health groups have supported keeping Makena on the market while further study is done, worried that pulling it could deepen health inequities. “We believe that removing access will have a detrimental impact on the health of women and birthing people at risk of recurrent preterm births and will not impact all women equally,” said Martha Nolan, senior policy adviser at HealthyWomen, nonprofit women’s health group focused on helping women making informed decisions about their care.

Members of the panel, which is made up of maternal health experts, neonatologists, statisticians, and other experts, related the difficulty of their decision.

“I’m so disappointed … I wish we weren’t sitting here today,” one member said. Another expressed “deep sadness” about the large trial of Makena that showed no benefit.

Esther Eisenberg, a reproductive endocrinologist, supported withdrawing the drug, “but I’m very conflicted. This is a very very difficult question.”

Cassandra Henderson, a maternal-fetal medicine specialist in New York City who was the sole panel member who argued the large clinical trial showed promise for some patient subgroups and who voted to keep the drug on the market, said she was concerned about the low representation of minority women in the trial, as “we do know race is sort of a surrogate for racism and all the structural inequities.”

Drugmaker Covis Pharma and its backers have argued that study may have missed its benefits in high-risk populations in the United…