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.”
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’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.
In trials for mifepristone, less than 0.5 percent of women who took the drug experienced a serious adverse reaction, such as sepsis, according to
the FDA label.
Kennedy had told senators during one of his confirmation hearings that President Donald Trump asked him to study the safety of mifepristone.
“He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies,” he said at the time.
Some groups and senators, including Sen. Bill Cassidy (R-La.), have also asked the FDA to reinstate limitations on mifepristone that were removed during the Biden administration, including the requirement that the drug be dispensed in person.
After Hawley asked Kennedy on May 14 about that aspect, Kennedy said that Makary would make a recommendation.
“I feel that the policy changes will ultimately go through the White House, through President Trump,” Kennedy said.
The Center for Reproductive Rights, a nonprofit that advocates for abortion access, was among the organizations critical of Kennedy’s remarks.
“President Trump ... should not be making decisions about our healthcare,” the center
said on X, “and RFK Jr. should not be interfering with our ability to access medication that’s been proven safe and effective.”
