The Food and Drug Administration (FDA) will make the case to withdraw the drug Makena from the market, but the drug maker says if the agency does it will affect Black women.
The Washington Post reports the agency doesn’t believe the drug works and will make the case during several advisory committee meetings in Washington, D.C. this week.
Meanwhile, Clovis Pharma, which holds the patent to Makena, and CEO Michael Porter argue there is evidence from a 2003 study showing the drug’s effectiveness in a narrow population that includes Black women, who have a higher risk of maternal complications.
The study was used to grant Makena an accelerated approval of the drug by the FDA. Several Black health groups support keeping the drug on the market. According to the Washington Post
, the NAACP worries the removal of Makena will “deepen profound existing maternal and infant health inequities in the U.S.” due to limited alternatives.Preterm birth affects about 10 percent of babies born in the U.S. According to the Office of Minority Health, Black babies have 2.3 times the infant mortality rate, are four times more likely to die from complications related to low birth weight, and are twice as likely to die from SIDS as white babies.
Doctors across the country are now confused as to whether to continue prescribing the drug for women who’ve already experienced preterm birth. The situation also brings up questions about race, class, and access to healthcare.
While Makena has support from Clovis, Black groups and even doctors, including Patrick Ramsey, a professor of obstetrics and gynecology at the University of Texas Health Science Center, the drug has its skeptics inside and outside the FDA.
Adriane Fugh-Berman, a professor at the Georgetown University Medical Center, accused Clovis Pharma of exploiting race to maximize profits. Clovis Pharma was purchased in 2020 by Apollo Global Management for $700 million, in part due to the potential of Makena. The drug is used by more than 325,000 women across the U.S., but it’s also expensive, costing up to $10,000 in some cases.
Additionally, Dr. Adam Urato, a maternal-fetal medicine specialist, filed testimony for the FDA, saying medical experts inside and outside the agency have analyzed clinical trials to find evidence of the drug’s effectiveness but have found none.
The FDA’s effort to have the drug removed goes back to 2019, when an expert panel voted 9-7 that Makena should be removed, but the process was delayed due to the COVID-19 pandemic and other issues.