U.S. Food and Drug Administration (FDA) Commissioner Marty Makary recently told a D.C. confab that he has “no plans to take action” on mifepristone, the chemical abortion drug responsible for more than 70 percent of abortions in the United States.
That’s a decidedly different answer than the one he gave me under oath. During his confirmation hearing, Dr. Makary pledged “to review the totality of data” with respect to mifepristone. He also said that 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.”
Well, the new data is here. And it’s sending a signal that can’t be missed: Mifepristone is not safe.
Last Monday, the Ethics and Public Policy Center published a massive, in-depth report examining more than 865,000 cases of prescribed mifepristone abortions between 2017 and 2023. The data comes from insurance claims records and constitutes the largest study on mifepristone ever undertaken.
The results? Nearly 11 percent of women who use the drug to induce an abortion suffer an “adverse health event” — as in a major, potentially life-threatening medical disaster. We’re talking about things like sepsis, infection, and hemorrhaging, the kind of things that land you in an ER. The kind of things that could lead to death. And the data reveals this happens to more than 1 in 10 women taking mifepristone.
Those are astounding, jaw-dropping numbers, and they have been largely hidden from the public. The rate of serious health events revealed by the EPPC study is some 22 times greater than the numbers reported on the FDA-approved drug label. The FDA’s official numbers, by the way, rely on clinical trials more than four decades old.
All of which means this: It’s time for the Trump administration to put back in place the safety regulations on mifepristone without delay.
The federal government once acknowledged the serious risks of this dangerous drug. When mifepristone was first approved, the government imposed a host of safety measures. Those included prescription by physician only, a requirement that physicians dispense the drug, mandatory follow-up physician visits, reporting of adverse events, and even a “black box” warning alerting women to the drug’s many dangers. And all this was done by the Clinton administration.
But soon Democrats, joined by Big Pharma, launched a campaign to roll back the safeguards. President Obama reduced the number of required in-person visits and removed the physician-prescription requirement. Then, in an attempt to mask the drug’s true risks, his administration ended the mandatory adverse-event reporting, meaning doctors no longer had to admit when the drug sent their patients to the hospital.
When Joe Biden came to office, the abortion lobby kicked into high gear. The Biden administration eliminated in-person checkups entirely and even did away with the long-standing mandate that physicians dispense the drug in person. Why make these changes? Simple. So mifepristone could be sent through the mail.
Now a nationwide network of leftist “health groups” prescribes the drug via video chat, and liberal activists mail it — often free of charge — into every state in the nation, including those states that restrict abortion. As a consequence, there are more abortions now than when Roe was still law: about 1,038,090 abortions in 2024 alone. Abortion activists brag that by eliminating mifepristone safeguards, they have “revolutionized abortion access in the U.S.” in a manner pro-lifers “will likely not be able to stop.”
Except we can stop this abortion-on-demand bonanza. At the very least, the Trump administration can, and should, reinstate the full complement of mifepristone safety regulations immediately. Only doctors should be able to prescribe the drug, and only after a real-life, in-person visit. Only doctors should be able to dispense and administer it, and only in a clinical setting. And there should be mandatory safety checkups afterward. For its part, Congress should make all of these rules permanent by writing them into law.
The new data speaks for itself: Mifepristone is a remarkably dangerous drug that threatens the lives of both baby and mother. 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.
Josh Hawley is a U.S. senator from Missouri and former Missouri attorney general.
