FDA Commissioner, Chief Scientist Must Move Swiftly to Remove Medication for Prevention of Preterm Birth from Market

WASHINGTON, D.C. – At the conclusion of the U.S. Food and Drug Administration’s (FDA’s) three-day hearing to consider the agency’s proposal to withdraw the accelerated approval of Makena (hydroxyprogesterone caproate) for prevention of preterm birth in certain high-risk women, members of the FDA’s Obstetrics, Reproductive, and Urologic Drugs Advisory Committee voted 14 to 1 in favor of the proposal. Public Citizen had petitioned the FDA in 2019 to ban the drug after a large post-approval clinical trial found that it is not effective for preventing preterm birth, or major complications in newborn infants related to preterm birth. A final decision on whether to remove Makena from the market will be made by FDA Commissioner Robert Califf and Chief Scientist Namandjé Bumpus. Dr. Michael Carome, director of Public Citizen’s Health Research Group, released the following statement:

“Public Citizen applauds the near-unanimous recommendation of the FDA’s Obstetrics, Reproductive, and Urologic Drugs Advisory Committee to remove Makena from the market. This science-based recommendation was the only logical outcome.

“We urge Commissioner Califf and Chief Scientist Bumpus to expeditiously act on this recommendation and finalize the agency’s proposal to withdraw the approval of Makena. Such action is long-overdue. In the absence of evidence showing that Makena is effective for reducing the risk of preterm labor, it is unacceptable to continue to expose women and their fetuses to the known and potential risks of the drug.”