Center for Reproductive Rights Sues HHS and FDA Over Review of Mifepristone

The Center for Reproductive Rights filed a lawsuit against the Department of Health and Human Services and the Food and Drug Administration on Friday, saying the agencies have refused to produce records related to the FDA’s decision to review the safety of the abortion pill mifepristone.

In a complaint filed under the Freedom of Information Act, the group said it made requests for documents about the FDA’s review process, the data the agency used to decide to reevaluate the drug and whether HHS or outside actors influenced the decision. The CRR said the agencies failed to respond to the FOIA requests, which it said triggered the lawsuit seeking the withheld records.

FDA Commissioner Martin Makary announced in June that the agency would review mifepristone, a medication that has been FDA-approved and widely used for about 25 years. The CRR alleges that the timing and basis for that announcement suggest political interference and that the agency relied on a recent report that critics describe as flawed.

The report, published in April by the Ethics and Public Policy Center, a conservative think tank, concluded that nearly 11% of women "experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion." The paper was not peer-reviewed and did not share underlying data, a factor that data scientists and other researchers have said makes independent verification impossible and undercuts the report’s conclusions.

The CRR's complaint seeks documents covering the FDA’s rationale for reopening its review, what data were considered, and any communications between the FDA, HHS and outside parties. "The public deserves to know if the FDA is making decisions about medication abortion based on debunked information or in response to political pressure," Rachana Desai Martin, the CRR’s chief U.S. program officer, said in a press release accompanying the filing.

The Ethics and Public Policy Center defended its decision not to seek peer review, with a spokesperson saying the organization believed there was an "extensive pro-abortion bias in the peer-review process" that would limit opportunities to publish critiques. The EPPC report was funded and issued by the think tank, which is listed as an advisory board member of Project 2025, a right-leaning policy agenda that has urged presidential appointees to the FDA to restrict mifepristone.

Republican lawmakers and anti-abortion advocates circulated the EPPC findings. Sen. Josh Hawley, R-Mo., pressed FDA officials in a letter that cited the report and urged action to "restore critical safeguards on the use of mifepristone." The CRR said Makary’s announcement followed Hawley’s letter and that HHS Secretary Robert F. Kennedy Jr. also referenced the report and its 11% figure during a May Senate hearing.

"We're getting data in all the time, new data that we're reviewing," Kennedy told lawmakers at that hearing, according to a transcript. "And we know that during the Biden administration, they actually twisted the data to bury one of the safety signals, a very high safety signal – around 11%. So we're gonna make sure that doesn't happen anymore."

HuffPost reported that data scientists who examined the EPPC analysis said the report’s recommendations did not align with the data it claimed to have analyzed. The CRR cited those critiques in asserting that the review appears motivated by ideology rather than peer-reviewed evidence.

The FOIA lawsuit seeks to force the agencies to produce records subject to public disclosure laws. FOIA requires federal agencies to release non-exempt records requested by members of the public, and CRR says it filed the suit after the agencies failed to respond to its requests. HHS and the FDA did not immediately respond to requests for comment.

The legal challenge comes amid heightened national debate over medication abortion and ongoing efforts in some policy circles to limit access to mifepristone. The outcome of the lawsuit could reveal what evidence the FDA is considering and whether outside advocacy or political pressure influenced the agency’s decision to reopen its evaluation of a drug that has played a central role in reproductive care for millions of patients.

The case is likely to draw scrutiny from medical groups, patient advocates and lawmakers on both sides of the abortion debate as it moves through the courts and as the FDA proceeds with its internal review process.