Internal records show mifepristone has remained safe over time
TUESDAY, Jan. 13, 2026 (HealthDay News) — The abortion pill mifepristone has long been at the center of heated political discussions.
But a new review suggests that behind the scenes, the federal agency that regulates the drug usually followed the science, not politics, when making key decisions about it.
The study — published Monday in the Journal of the American Medical Association — examined how the U.S. Food and Drug Administration (FDA) handled regulatory decisions about mifepristone between 2011 and 2023.
Researchers reviewed thousands of pages of internal FDA documents, including emails and staff memos.
In nearly every major decision, they found that FDA leaders accepted recommendations made by the agency’s scientists.
“We found that FDA staff and scientists were basing the recommendations on the evidence, and that’s how it’s supposed to be,” study co-author Dr. Caleb Alexander, a professor at Johns Hopkins Bloomberg School of Public Health, told The New York Times.
The researchers identified one notable departure from that pattern.
In 2020, during the height of the pandemic, FDA scientists approved allowing mifepristone to be prescribed by telemedicine and mailed to patients.
The goal was to reduce in-person visits while people were being told to stay home.
But FDA leadership at the time declined to lift the in-person requirement and defended it before the U.S. Supreme Court, despite findings that the drug could be safely used without an in-person office visit.
That policy changed in 2021, when the FDA removed the in-person requirement after Democrat Joe Biden became president.
The review comes as abortion pills have become a major legal battleground in the wake of the Supreme Court’s 2022 decision ending the nationwide right to abortion.
Today, medication abortions account for about two-thirds of all abortions in the United States.
Several conservative-led states are pushing lawsuits that could sharply limit access to mifepristone or even undo its approval, which dates back 25 years.
At the same time, abortion rights groups and Democrat-led states are asking the FDA to loosen restrictions even more.
U.S. Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary have said the agency will again review mifepristone’s safety, despite decades of data showing serious complications are rare.
Internal FDA reviews examined in the JAMA study show that the agency repeatedly confirmed that mifepristone is safe.
One analysis found that among 1.88 million patients who had used the drug in the U.S. by late 2012, 2,740 adverse events were reported. About 1 in 2,448 patients required hospitalization.
Fourteen deaths were reported during that period, but at least three were unrelated to the medication, including one involving a suspected homicide and others linked to drug overdoses.
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