Secretary of Health and Human Services Robert F. Kennedy Jr. has tasked the Food and Drug Administration with conducting a safety assessment of Mifepristone, the primary medication used in most abortions in the U.S. This week, Kennedy indicated that the review was prompted by a “surprising” report on significant adverse events that was released last month.
“At the very least, it clearly indicates that we need to modify the labeling,” he stated during the Senate budget hearing on Wednesday, addressing Senator Josh Hawley (R-Mo). “We requested FDA Director Marty McCurry to carry out a comprehensive review and provide a report.”
The report suggests that neither peer-reviewed studies nor medical journals have identified a higher rate of serious complications from Mifepristone than that reported by the FDA. It calls for “further investigation into the harm Mifepristone may cause to women” and urges a “reconsideration of its approval entirely.”
Published online in April by the Center for Ethics and Public Policy, a conservative think tank that endorses Jewish and Christian values, the center is associated with the Advisory Committee for Project 2025, which pushes right-wing policy initiatives allegedly influencing many recent actions by President Donald Trump.
A few days before the report’s release, FDA Commissioner Marty McCurry mentioned that he had no intention of taking action against Mifepristone unless new data indicated safety concerns.
Hawley has consistently voted to restrict abortion access, and called on McCurry last month to restore certain restrictions that have made obtaining Mifepristone challenging, including requiring doctors to handle the process directly.
Conversely, data shows that fewer than 0.5% of women taking Mifepristone experience serious side effects, while the report claims the actual figure is about 11%.
Researchers studying reproductive health have criticized the report as junk science, exaggerating the medication’s risks.
Dr. Ushima Upadyyay, a public health scientist from the University of California, San Francisco, expressed on Thursday, “We should be cautious about public health officials demanding a review of science.”
“A rigorous study, which involved my own consultation with a clinician, ensured that the medication is safe for use at home,” she added.
The report claims its analysis is based on 865,727 insurance claims for women prescribed abortion medications, yet it does not disclose the database used, failing to adhere to standard scientific research protocols. Multiple external researchers have noted that the definition of a “serious adverse event” is broad enough to capture minor side effects like daily bleeding. However, the report’s authors assert that they excluded mild or moderate events.
Regardless, complications after medication abortions were categorized as “serious” in contradiction to medical consensus. The Mifepristone label already indicates that the treatment fails in roughly 2.6% of cases, with the physician community suggesting the failure rate may reach up to 5%. Additionally, the report classified ectopic pregnancies as serious incidents, even in the context of Mifepristone use.
Alina Salganicoff, the director of the Women’s Health Policy Program at KFF—a health policy research and news organization—asserted that the report “does not meet generally accepted research standards,” noting that using insurance claims to evaluate abortion outcomes is ineffective as “many abortions, especially early ones, are not covered by insurance.”
Rachel Jones, a leading research scientist at the Guttmacher Institute, an organization advocating for abortion access, remarked that the report seems to stem from ideology rather than science.
“The FDA typically relies on clinical trials and studies, but this isn’t the case here. It should not influence current policies,” she stated.
The authors of the report responded to these criticisms in a post on the Center’s website, claiming the peer review system is biased against anti-abortion groups, leaving “no opportunity to publish peer-reviewed analyses that provide critical views on abortion medications.”
“As the largest ever study on abortion drugs reveals they are neither safe nor effective, the abortion industry has opted to misrepresent our findings to protect their financial interests, jeopardizing women’s health,” said the report.
Dr. Christina Francis, CEO of the American Pro-Life Physicians Association, indicated that the report sends a message for the FDA to conduct a thorough reassessment of Mifepristone’s safety.
“We have long urged the FDA to conduct a more detailed review of the real-world complication rates,” she explained. “In my view, this report is timely and much needed.”
HHS, which handles media inquiries for the FDA, did not provide comments upon request.
Reproductive health researchers argue that disseminating flawed research represents one of the many strategies employed by anti-abortion groups to restrict access to Mifepristone, alongside litigation and lobbying federal officials.
“Organizations wishing to ban abortions often produce these types of studies,” said Jones.
Misleading research has previously contributed to legal challenges against Mifepristone access, which were ultimately withdrawn by the Supreme Court. In a 2023 decision temporarily revoking Mifepristone’s approval, U.S. District Judge Matthew Kakusmalik cited a study from an anti-abortion group that was later retracted by a medical publisher.
Attorneys General from Idaho, Kansas, and Missouri sought to revive a lawsuit in October against Mifepristone in the same Texas federal court. However, earlier this month, the Trump administration requested the judge dismiss the case.
Julia Kaye, a senior staff attorney with the ACLU Reproductive Freedom Project, indicated at a press conference that this might complicate the administration’s legal arguments in other ongoing cases. Other legal experts view this as a strategy to sidestep taking a definitive stance on abortion.
During his confirmation hearing, Kennedy pledged to align with Trump on abortion issues, proposing on Wednesday that Trump would ultimately determine how Mifepristone is managed in the U.S.
“We believe that policy shifts will ultimately pass through President Trump,” he stated.
