Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has launched an investigation into the risks of the abortion drug mifepristone, the Daily Caller News Foundation confirmed Thursday.
In a letter to 22 Republican attorneys general dated Sept. 19, reviewed by the DCNF, Kennedy and Food and Drug Administration (FDA) Commissioner Marty Makary said 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.”
The attorneys general had urged the FDA in July to reassess the safety of the abortion pill, which now accounts for nearly two-thirds of abortions annually and is increasingly common even in states with restrictions.
“The concerns you have raised in your letter merit close examination. This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” Kennedy and Makary wrote.
They added that the review was prompted by “the lack of adequate consideration underlying the prior [Risk Evaluation and Mitigation Strategy (REMS)] approvals, and by recent studies raising concerns about the safety of mifepristone as currently administered.”
One such study, conducted by the Ethics and Public Policy Center, analyzed insurance data and found nearly 11% of patients reported a “serious adverse event” after taking the abortion pill — including hemorrhaging, sepsis, fallopian tube rupture, and infection — compared to the 0.5% rate listed on the drug label.
A separate peer-reviewed study, not cited by Kennedy, concluded there is no scientifically valid basis for the oft-repeated claim that mifepristone is safer than Tylenol.
“HHS is committed to studying the adverse consequences reported in relation to mifepristone to ensure the REMS are sufficient to protect women from unstated risks. Therefore, through the FDA, HHS will conduct a study of the safety of the current REMS, in order to determine whether modifications are necessary,” Kennedy and Makary added.
The requirements for obtaining the abortion drug were significantly reduced under the Biden administration, with the FDA permanently eliminating an in-person dispensing requirement for the abortion pill in 2023. The Supreme Court dismissed a challenge to the FDA’s regulations brought by doctors and pro-life medical associations in 2024, finding they lacked standing to sue.
During a DCNF investigation in June, five online abortion providers supplied pills for “future use” without a doctor verifying key medical information, like the stage of pregnancy.
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