The Problem With the FDA’s Quick-Approval Process for Drugs

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A decade after the agency gave the nod to Makena, to prevent premature births, it’s not clear the medicine works, reports Bloomberg

One in 10 babies in the U.S. is born premature, with elevated rates of disability and death. For almost a decade, a drug called Makena has been used to reduce the risk of further instances of early delivery for women who’ve previously given birth prematurely. The medicine, approved in 2011 under the Food and Drug Administration’s accelerated process, contributed more than $300 million of annual sales for its manufacturer, Amag Pharmaceuticals Inc.

New research calling into question how well the drug works is now prompting the FDA to consider delisting Makena—a rare step for an approved treatment. For the women in a follow-up study required by the FDA, released last year, Makena did not decrease repeated preterm births. “To see these women and their families have to go through this experience multiple times is heartbreaking,” says Michal Elovitz, a physician and director of the Maternal and Child Health Research Center at the University of Pennsylvania’s Perelman School of Medicine. “They want to know why and why it didn’t work. And the only answer we have for them is we have to figure that out.”

Amag Pharmaceuticals stands by the efficacy of Makena and wants to keep it on the market while more research is done. The recent trial, which took a decade to complete and release, was complicated by the drug’s U.S. approval, according to Amag. With the treatment widely available, the company says, doctors were hesitant to put prospective mothers in testing where they risked receiving a placebo. It also says that demographic differences among patients may have affected the results.

Until the FDA makes a decision about Makena—it hasn’t indicated when this will happen—doctors and hospital staff will find themselves weighing an older favorable study against a newer damaging one. The two major national professional organizations in this field—the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine—continue to say Makena is an option for at-risk pregnant women. “The jury’s still out on this,” says Mary Norton, a physician who co-wrote the Society for Maternal-Fetal Medicine’s statement about Makena, and noted that the drug is considered safe.

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