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

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.”