Health and Human Services Secretary Robert F. Kennedy Jr. has ordered a safety review of mifepristone, the abortion pill used in most U.S. medical terminations, following a controversial report claiming increased health risks.
During a Senate budget hearing on Wednesday, Kennedy told Sen. Josh Hawley, R-Mo., that he directed Food and Drug Administration Commissioner Marty Makary to re-evaluate mifepristone’s safety. He cited an “alarming” new report alleging that the rate of serious complications is far higher than official estimates.
The report, published in April by the conservative Ethics and Public Policy Center, asserts a 22-fold increase in adverse events compared to FDA data and urges the agency to reconsider mifepristone’s approval. However, the study has not been peer-reviewed or published in a medical journal, prompting criticism from health experts who warn against basing public policy on unverified science.
“This is junk science,” said Dr. Ushma Upadhyay, a public health researcher at the University of California, San Francisco. “We should be alarmed that our institutions are being guided by a report that lacks transparency and rigor.”
The report analyzed over 865,000 insurance claims but failed to disclose its data source. Experts also questioned its definition of “serious adverse events,” which may include non-serious effects such as bleeding or incomplete abortions—outcomes already noted in FDA guidelines. It also categorized ectopic pregnancies, which are not caused by the drug, as complications.
Reproductive health researchers and policy analysts say the report exaggerates risks and lacks the standards expected of credible research. Alina Salganicoff of KFF said insurance claims data is inadequate for evaluating abortion safety, as many procedures aren’t billed to insurers.
Dr. Christina Francis, CEO of the American Association of Pro-Life Obstetricians and Gynecologists, defended the report, saying it shows the need for deeper FDA scrutiny. “We’ve been asking for this review for years,” she said.
The FDA previously said it would not act on mifepristone without new credible safety data. Hawley and other abortion opponents have used the report to call for reinstating stricter rules, such as requiring in-person dispensing.
Critics argue the report is the latest attempt to restrict access through misinformation. “This is part of a broader pattern,” said Rachel Jones of the Guttmacher Institute. “Ideologically driven groups are increasingly using flawed studies to influence policy.”
In 2023, a federal judge temporarily suspended FDA approval of mifepristone, citing studies from anti-abortion groups—some of which were later retracted. Though that ruling was overturned, legal efforts persist. Attorneys general from several states revived the case in Texas, but the Trump administration recently asked the court to dismiss it.
The Ethics and Public Policy Center maintains that it is being targeted for exposing the “truth” about abortion pills. Its communications director claimed the peer-review process is biased against anti-abortion perspectives.
Kennedy signaled that ultimate decisions on abortion policy will rest with former President Donald Trump. “I feel that the policy changes will ultimately go through the White House,” he said.
