Food and Drug Administration Commissioner Marty Makary said he plans to undertake a review of mifepristone, also known as the abortion pill, amid research showing that the drug is more dangerous than the agency has previously reported.
The FDA approved mifepristone for use in elective pregnancy termination in 2000. Still, Dr. Makary confirmed Monday in a letter to Sen. Josh Hawley, Missouri Republican, that the drug is once again on the agency’s radar.
“As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,” Dr. Makary said in the letter. “As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data.”
He said he was unable to comment further because the agency’s approval of mifepristone is the subject of pending litigation.
Dr. Makary’s comments represent an evolution in his position since April, when he said at the Semafor World Economy Summit that “I have no plans to take action on mifepristone,” with the caveat that he would go where the evidence leads him.
Mr. Hawley has prodded Trump administration officials and nominees to reexamine the agency’s approval of mifepristone, one of two drugs in the abortion-pill protocol, spurred by safety concerns raised in studies conducted by pro-life research groups.
Under questioning by Mr. Hawley, Health and Human Services Secretary Robert F. Kennedy Jr. told a Senate panel May 14 that he would seek an FDA review of mifepristone after a largest-of-its-kind study found that the drug was 22 times more dangerous than billed on its label.
“It’s alarming, and it indicates that at the very least, the label should be changed,” Mr. Kennedy said, referring to the Ethics and Public Policy Center research. “I’ve asked Marty Makary at the FDA to do a complete review and report back.”
FDA chief Marty Makary just committed to me to do a full review of the chemical abortion drug’s safety: “As Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone” pic.twitter.com/nMxUhE18UA
— Josh Hawley (@HawleyMO) June 3, 2025
The EPPC report, released April 28, found that 10.93% of women who took the abortion pill were treated for conditions such as sepsis, hemorrhaging and infection, even though the FDA label says that less than 0.5% of women experience “severe adverse reactions.”
James O’Neill, President Trump’s nominee for HHS deputy director, also told the Senate Health, Education, Labor and Pensions Committee that a review is warranted.
“The Secretary has pledged to do a safety review of mifepristone, and I strongly support that view,” Mr. O’Neill told the committee at its May 8 hearing.
The FDA has maintained that mifepristone is “safe when used as indicated” to terminate pregnancies up to 10 weeks’ gestation.
Last year, the Supreme Court ruled against a challenge to the FDA’s approval of mifepristone, reasoning that the pro-life medical groups and physicians who brought the lawsuit lacked standing.
Three states — Missouri, Kansas and Idaho — have since revived the mifepristone legal challenge, filing the case in the U.S. District Court for the Northern District of Texas (Amarillo division).
On the other side, a 2023 lawsuit filed by Whole Women’s Health Alliance seeks to lift restrictions on the drug’s access, such as the requirement that prescribers register with the drug manufacturer, in a case filed in U.S. District Court for the Western District of Virginia (Charlottesville division).
