The Food and Drug Administration is reviewing the safety of the abortion pill mifepristone, Health and Human Services Secretary Robert F. Kennedy Jr. said in a recent letter to Republican state attorneys general.
Conservatives and anti-abortion groups have criticized the drug, particularly after the Biden administration in 2023 made it possible for women to receive mifepristone via telehealth and by mail. The majority of women who terminate pregnancies do so through medication abortions.
Republican attorneys general had written to Kennedy on the matter in July, and in response, Kennedy said the FDA is taking a look at the drug’s Risk Evaluation and Mitigation Strategy. Kennedy in June asked FDA Commissioner Martin Makary to “review the latest data” on the drug, an FDA spokesperson confirmed at the time. The spokesperson did not respond to further questions about when the review would start or what specifically it was reviewing about the drug.
In their Sept. 19 letter to the states, Kennedy and Makary wrote, “HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”
“Recent studies — such as the study by the Ethics and Public Policy Center (EPPC), which you highlighted in your letter — indicate potential dangers that may attend offering mifepristone without sufficient medical support or supervision,” the letter continued. “FDA’s own data collected between 2000 to 2012 indicated 2,740 adverse events, including 416 events involving blood loss requiring transfusions. Since then, safeguards for women regarding the administration of mifepristone have been significantly reduced.”
According to EPPC, its study found nearly 11% of women “experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion,” but CBS News medical contributor Dr. Celine Gounder told “CBS Evening News,” “Other data sources show the rate of serious complications to be much lower, at less than 1 in 200.”
The EPPC study cited by Kennedy and lawmakers like Sen. Josh Hawley of Missouri, is one that says it focuses on “applying the Judeo-Christian moral tradition” to public policy.
Asked whether the review could lead to a ban on mifepristone, Gounder suggested it would be difficult for the FDA to withdraw approval, an extraordinary step that would quickly draw legal challenges, but said depending on what the safety review finds, it could make access more difficult, limiting the drug’s availability through telehealth or by mail, or restricting the ability to prescribe it to doctors, rather than physician assistants or nurses who are also currently able to prescribe it.
Kennedy and Makary did not say when their review would be completed, but told the states, “We will keep you informed as the FDA’s review of mifepristone progresses.”
Advocates of access to the abortion pill insist it’s safe.
“More than 100 studies confirm mifepristone’s exceptional safety record,” the American Civil Liberties Union said in a statement in response to the mifepristone safety review. “Today, medication abortion accounts for nearly two-thirds of abortions in the U.S, and the nation’s leading medical associations now stress mifepristone’s importance not only for abortion but for miscarriage care as well.”
Mifepristone is approved to terminate a pregnancy through 10 weeks of gestation. It was first approved by the FDA in 2000, and has, according to the ACLU, been used by more than 7.5 million women since then.
