Pressure is building on the Food and Drug Administration to reinstate safeguards on the abortion pill after a largest-of-its-kind study found the number of serious health scares far higher than the agency has previously acknowledged.
Congressional Republicans joined pro-life advocates in urging the agency to take a fresh look at the data after explosive research released last week showed that 10.93% of women who were prescribed mifepristone were treated within 45 days for conditions including sepsis and hemorrhaging.
That figure is 22 times higher than that on the drug’s warning label, which puts the adverse event rate at less than 0.5%, according to the Ethics and Public Policy Center study of 865,727 cases.
“The science is clear: the abortion pill is not safe for women, and it never has been,” Sen. Steve Daines, Montana Republican, said in a statement. “This recent study is proof that pro-abortion advocates care more about promoting their radical agenda than they do about women’s health.”
The FDA approved mifepristone for pregnancy termination in 2000. Under the Obama and Biden administrations, however, the agency reduced the number of required in-person medical visits from three to zero, allowing the pills to be prescribed via telehealth and delivered through the mail.
“I urge the FDA to reinstate safety protocols for mifepristone, so that we can protect the health of women and uphold the dignity of life,” said Mr. Daines.
Rep. Chris Smith, who co-chairs the House Pro-Life Caucus, accused the FDA of a “massive cover-up,” while Sen. Josh Hawley fired off a letter to the FDA urging it to “restore critical safeguards on the use of mifepristone.”
“The health and safety of American women depend on it,” Mr. Hawley, Missouri Republican, said in his April 28 letter to FDA Commissioner Marty Makary.
Such pleas would have had little chance of swaying the FDA during the Biden administration, but under President Trump, there’s a new sheriff in town.
Dr. Makary, a professor at the Johns Hopkins School of Medicine, has shown a willingness to shake up the medical establishment since being sworn in as FDA commissioner on April 1.
Ten days later, he announced plans to phase out animal testing in the development of monoclonal antibody therapies. He has also barred employees at pharmaceutical companies from serving as official members of FDA advisory committees except in extraordinary cases.
Dr. Makary, who drew national attention for his opposition to COVID-19 vaccine mandates, has not said that he will review the mifepristone protocol — but he hasn’t said that he won’t, either.
At the Semafor World Economy Summit last month, Dr. Makary said, “I have no plans to take action on mifepristone” before adding that he would go wherever the evidence leads him.
“I believe in science. You’ve got to evolve as the data comes in, and as you may know, there is an ongoing set of data that is coming into FDA on mifepristone,” Dr. Makary said at the April 24 event. “If the data suggests something or tells us there’s a real signal, we can’t promise that we’re not going to act on that data that we have not yet seen.”
Mr. Hawley argued that “the time to act is now.”
“The new data speaks for itself: Mifepristone is a remarkably dangerous drug that threatens the lives of both baby and mother,” Mr. Hawley said Monday in an op-ed in The Federalist. “Those who have pretended otherwise have lied to us. Now is the time to set the record straight and protect the lives of millions of Americans.”
Dr. Marty Makary, the FDA commissioner, tells @IAmAmnaNawaz that he has “no plans to take action” on mifepristone, which is used in medication abortion.
If new data came in and contradicted decades of data that said mifepristone is overwhelmingly safe and effective, Makary said… pic.twitter.com/8CxOApKdFD
— PBS News (@NewsHour) April 24, 2025
The two-drug abortion pill protocol of misoprostol and mifepristone has become the most popular method of U.S. pregnancy termination, accounting for two-thirds of all abortions, according to the pro-choice Guttmacher Institute.
The American College of Obstetricians and Gynecologists said in 2023 that the “overwhelming weight of scientific evidence has conclusively demonstrated that mifepristone is safe and effective,” while Planned Parenthood has called mifepristone “safer than Tylenol.”
Meanwhile, pro-life advocates have accused the medical establishment of dismissing growing concerns about the drug.
The pro-life Charlotte Lozier Institute has raised doubts about mifepristone’s safety in a series of studies, including a 2021 paper that found emergency-room visits by women who had taken the abortion pill in the last 30 days jumped by 500% from 2002 to 2015.
Pro-life medical groups sued the FDA to overturn its 2000 approval of mifepristone, arguing that the agency violated the Administrative Procedure Act, but the Supreme Court dismissed the case last year for lack of standing
