Trump Officials’ Mifepristone Safety Claims Rely on Contested Anti-Abortion Report

Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary have pledged to review mifepristone, a key drug used in medication abortion, citing a controversial report from the Ethics and Public Policy Center (EPPC), a conservative anti-abortion organization.

The report, released in April, claims mifepristone has a serious adverse event rate of 10.93% – approximately 22 times higher than the less than 0.5% rate indicated on FDA-approved labeling. Kennedy called these findings “alarming” during a May Senate hearing, suggesting the drug’s label should be changed.

Medication abortion, which uses mifepristone in combination with misoprostol, accounts for 63% of U.S. abortions according to the Guttmacher Institute. The procedure is FDA-approved for terminating pregnancies through the first 10 weeks of gestation.

However, reproductive health experts have raised significant concerns about the EPPC report’s methodology and conclusions. In August, 263 reproductive health researchers signed a letter stating the report “does not provide reliable evidence” for its claims and contradicts decades of established research.

“Decades of conclusive scientific evidence amassed through more than one hundred rigorous studies based on hundreds of thousands of patient outcomes have overwhelmingly established the safety and effectiveness of mifepristone,” the researchers wrote.

Dr. Stella M. Dantas, then president of the American College of Obstetricians and Gynecologists, told AFP Fact Check that the EPPC report “manipulates data to drive a myth that medication abortion isn’t safe.”

One critical issue experts identified is the report’s lack of transparency about its data source. The EPPC claimed to have used “a commercially available all-payer health insurance claims database” covering all U.S. patients from 2017 to 2023, but refused to disclose which specific database it analyzed.

“Data transparency is a hallmark of high-quality research,” said Alina Salganicoff, director of the Women’s Health Policy program at KFF. “Without a disclosure, it is impossible to assess the methods and know the reliability and limitations of the data they used, and replicate the findings.”

EPPC communications director Hunter Estes told FactCheck.org that legal agreements prevented disclosure of the data vendor, though experts noted this is highly unusual in scientific research.

“Most of the data aggregator vendors that we work with have in their data use agreement/contract that their company name must be listed in publications,” explained Shirley V. Wang, a pharmacoepidemiologist at Harvard Medical School.

The report’s methodology has also drawn criticism. Researchers believe the EPPC significantly inflated adverse event rates by counting situations that shouldn’t qualify as serious complications.

Ushma Upadhyay, a public health scientist at the University of California, San Francisco, pointed out that the report appears to have counted emergency department visits as serious adverse events even though many abortion patients visit emergency rooms for reassurance about normal symptoms or follow-up care, not because of dangerous complications.

Additionally, the EPPC report counted incomplete abortions requiring follow-up procedures as “serious adverse events,” which contradicts standard medical classification. The report also failed to provide a clear definition for hemorrhage, potentially misclassifying normal post-abortion bleeding as a serious complication.

“Without a standardized definition, EPPC is likely misclassifying many cases of normal bleeding that occurs with a medication abortion,” the reproductive health researchers wrote in their letter.

Kennedy has specifically highlighted concerns about telehealth abortions, claiming on social media that “The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks.”

However, the FDA states it conducted a “comprehensive review” before modifying restrictions in 2023, finding “there did not appear to be a difference in adverse events between periods when in-person dispensing was and was not enforced.” Recent studies have continued to support telehealth abortion’s safety profile.

“All of the largest studies out there have found that telehealth is just as safe and effective as in-person care,” Upadhyay noted, citing a 2024 study of more than 6,000 telehealth abortions that found adverse event rates consistent with FDA labeling.

The EPPC was previously part of the advisory board for Project 2025, a conservative policy roadmap that advocated for the FDA to withdraw approval for medication abortion drugs or restrict their use, raising questions about potential political motivations behind the current review.