Health Secretary Robert F. Kennedy Jr. says the FDA will launch a safety review of the abortion pill mifepristone following a request from 22 Republican-led states.
The FDA’s decision to revisit the pill’s safety is fueling more concerns that it will be further restricted under President Donald Trump’s administration. It also highlights how the pill used in most U.S. abortions continues to be ensnared in politics that have plagued it for nearly a decade.
FDA mifepristone review
According to ABC News, Kennedy and FDA Commissioner Marty Makary are launching the review at the request of 22 Republican attorneys general.
What they’re saying:
The FDA said it would conduct “its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”
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“This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” RFK and Makary wrote in a letter to the attorneys general.
US President Donald Trump, left, and Robert F. Kennedy Jr., US secretary of Health and Human Services (HHS), in the Roosevelt Room of the White House in Washington, DC, US, on Monday, Sept. 22, 2025. (Photographer: Francis Chung/Politico/Bloomberg vi
In their request to the FDA, the attorneys general cited a study by the Ethics and Public Policy Center, a conservative think tank, but the study was not peer-reviewed, nor was it published in a scientific journal.
The other side:
Medical experts have said the study is “scientifically unsupported and should be dismissed.”
“Mifepristone has been studied for three decades and the scientific evidence is unequivocal that the medication is safe and effective,” the Society of Family Planning, an abortion research organization, said in a letter to the FDA. “Notwithstanding the overwhelming evidence, we understand you have received requests to apply scientifically invalid claims about its safety to a review of mifepristone’s label. Of note, we have grave concerns about a recent such request that relies on a self-published, non-peer-reviewed paper.”
FDA says mifepristone is safe
The backstory:
The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies. It’s commonly used with misoprostol, another drug, to terminate pregnancies in the U.S.
In 2023, the pill was used in more than six in 10 of the abortions in the U.S. It’s also one of the only ways to provide abortions in states where abortion is banned, because providers in other states can mail abortion pills to women in states where it’s illegal, ABC News reports.
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In 2016, FDA loosened restrictions on the drug to allow it to be prescribed up to 10 weeks of pregnancy and allowed nurses and other medical professionals to prescribe it. In 2021, the agency said the drug could be sent through the mail, doing away with a longstanding requirement that women pick the drug up in person.
Last year, the Supreme Court declined to restrict access to mifepristone in the wake of Roe v. Wade being overturned, but the high court’s decision did allow for future policy changes.
OB-GYNs say a tiny fraction of patients suffer “major” or “serious” adverse events after taking mifepristone. According to the FDA’s own data, since its approval in 2000, there have been 5 deaths for every 1 million people who used mifepristone, a death rate of 0.0005%, CNN reports.
There were more than 1 million abortions in the US last year, according to the Guttmacher Institute, a think tank that supports abortion rights.