The health secretary said that at the very least, the labeling for the drug should be changed.
Health Secretary Robert F. Kennedy Jr. said on May 14 that he has ordered the Food and Drug Administration (FDA) to complete a review of the abortion pill mifepristone.
Sen. Josh Hawley (R-Mo.), during a hearing in Washington, highlighted an analysis of insurance claims that found 11 percent of women who took the drug experienced serious adverse events, a percentage far higher than the reported rate of under 0.5 percent among clinical trial participants.
“I think the new data … is alarming, and clearly it indicates that at the very least, the label should be changed,” Kennedy said.
The health secretary said he told Dr. Marty Makary, the FDA’s commissioner, to do a complete review of the data and report back.
Hawley wrote on social media platform X that Kennedy “just pledged to conduct a top-to-bottom review of the drug—and said the FDA label needs to change,” calling the development “a win for life.”
A new study on the chemical abortion drug shows 11% of women experience adverse effects serious enough to send them to the ER@SecKennedy just pledged to conduct a top-to-bottom review of the drug – and said the FDA label needs to change
— Josh Hawley (@HawleyMO) May 14, 2025
That's a win for life pic.twitter.com/gy65iCZjI5
The FDA says on its website that mifepristone is safe when used properly.
Makary said during his confirmation hearing in March that once he entered office, he would review the data on mifepristone.
“I have no preconceived plans to make changes to the mifepristone policy,” he also said, in response to Democrat senators who urged him to acknowledge studies that they said show the pill to be safe and effective. One review from 2013, for example, found that the pill terminated pregnancies without further intervention for 96 percent of women who took the drug.
During a summit in April, Makary said that he had no plans to take action to limit the availability of mifepristone.
“There is an ongoing set of data that is coming into FDA on mifepristone,” he said. “So if the data suggests something or tells us that there’s a real signal, we can’t promise we’re not going to act on that data.”
Four days later, the Ethics and Public Policy Center published the analysis of insurance claims, which the authors said showed that mifepristone is not safe and effective. The center, which describes itself as “Washington, D.C.’s premier institute working to apply the riches of the Jewish and Christian traditions to contemporary questions of law, culture, and politics,” has not identified the source of the data.
