Internal records show mifepristone has remained safe over time<\/p>\n<\/h3>\n
By I. Edwards HealthDay Reporter<\/b>
\n<\/b><\/p>\n
TUESDAY, Jan. 13, 2026 (HealthDay News) \u2014 The abortion pill mifepristone has long been at the center of heated political discussions.<\/p>\n
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.<\/p>\n
The study<\/a> \u2014 published Monday in the Journal of the American Medical Association \u2014<\/em> examined how the U.S. Food and Drug Administration (FDA) handled regulatory decisions about mifepristone between 2011 and 2023.<\/p>\n Researchers reviewed thousands of pages of internal FDA documents, including emails and staff memos.<\/p>\n In nearly every major decision, they found that FDA leaders accepted recommendations made by the agency\u2019s scientists.<\/p>\n \u201cWe found that FDA staff and scientists were basing the recommendations on the evidence, and that\u2019s how it\u2019s supposed to be,\u201d study co-author Dr. Caleb Alexander<\/a>, a professor at Johns Hopkins Bloomberg School of Public Health, told The New York Times.<\/em><\/p>\n The researchers identified one notable departure from that pattern.<\/p>\n In 2020, during the height of the pandemic, FDA scientists approved allowing mifepristone to be prescribed by telemedicine and mailed to patients.<\/p>\n The goal was to reduce in-person visits while people were being told to stay home.<\/p>\n 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.<\/p>\n That policy changed in 2021, when the FDA removed the in-person requirement after Democrat Joe Biden<\/a> became president.<\/p>\n The review comes as abortion pills have become a major legal battleground in the wake of the Supreme Court\u2019s 2022 decision ending the nationwide right to abortion.<\/p>\n Today, medication abortions account for about two-thirds of all abortions in the United States.<\/p>\n Several conservative-led states are pushing lawsuits that could sharply limit access to mifepristone or even undo its approval, which dates back 25 years.<\/p>\n At the same time, abortion rights groups and Democrat-led states are asking the FDA to loosen restrictions even more.<\/p>\n U.S. Health Secretary Robert F. Kennedy Jr<\/a>. and FDA Commissioner Dr. Marty Makary<\/a> have said the agency will again review mifepristone\u2019s safety, despite decades of data showing serious complications are rare.<\/p>\n Internal FDA reviews examined in the JAMA<\/em> study show that the agency repeatedly confirmed that mifepristone is safe.<\/p>\n 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.<\/p>\n 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.<\/p>\n \u201cThere were very consistent findings on the safety of mifepristone, and the FDA has continued to monitor this based on many different types of data,\u201d Alexander told The Times.<\/em><\/p>\n In 2016, after another detailed review, the FDA expanded access to mifepristone.<\/p>\n It allowed more types of health care providers to prescribe it, extended use from seven weeks of pregnancy to 10, and let patients take the second drug in the regimen at home instead of in a doctor\u2019s office.<\/p>\n FDA scientists also recommended removing a patient agreement form they felt was “duplicative.”<\/p>\n That suggestion was rejected by the then-FDA commissioner, who said the form provided extra assurance that patients were informed.<\/p>\n More information<\/strong><\/p>\n The Mayo Clinic has more on mifepristone<\/a>.<\/p>\n