FDA: Mifepristone review won’t be done until March

The Food and Drug Administration (FDA) won’t publish its safety review of the abortion drug mifepristone until March, it disclosed in a Wednesday court filing, adding that it won’t impose any new restrictions on the pill before that point.

The revelations are likely to further anger anti-abortion activists, who have been losing patience with the Trump administration over what they say is the slow pace of the FDA’s review and failure to crack down on blue state doctors who send the pills across state lines.

In a five-page update filed in a Louisiana federal court, the agency said it is on track to obtain study results by mid-December but won’t finish its report until March.

The agency confirmed it is separately reviewing the safety program that regulates the distribution and use of mifepristone, called a “Risk Evaluation and Mitigation Strategy” — a protocol the FDA uses for drugs with “serious safety concerns.”

That process could take much longer, as the FDA said it will need to review the hundreds of citations included in various citizen petitions urging changes to the prescribing rules, such as the in-person dispensing requirement.

“Following completion of its study and review, FDA will decide whether changes to the Mifepristone REMS Program are necessary and, if applicable, initiate any such changes in accordance with established processes,” the agency wrote. “FDA anticipates that it will be able to provide an update to its estimated date of completion as more information becomes known, particularly in March 2027 when it expects to complete its report on the final study results.”

Abortion rights groups slammed the review as nothing more than a political stunt and said the administration is deliberately delaying its release until after November’s midterm elections.

“Mifepristone is a safe and effective medication backed by decades of science – this ‘review’ is an unnecessary political stunt,” Reproductive Freedom for All President and CEO Mini Timmaraju said in a statement. “The administration is delaying this report because attacks on medication abortion will backfire with voters, but extremists will try to ban abortion as soon as the election is over.”

FDA’s disclosure Wednesday stems from a lawsuit in Louisiana, one of three the agency is facing regarding mifepristone. The other legal challenges came out of Missouri and Texas.

A federal judge paused the Texas case on Aug. 31, while the Missouri case is still being briefed.

Medication has become the most common method of abortion since the 2022 overturning of Roe v. Wade, with much of that increase coming from telehealth prescriptions.

The Louisiana lawsuit challenges Biden-era FDA rules that allow the drug to be prescribed virtually and mailed to patients.

The case has put the Trump administration in an awkward political bind; it won’t defend the Biden administration’s moves, but it also believes Louisiana doesn’t have standing to sue.

Anti-abortion groups hope the review will result in restrictions on mifepristone, but they want the FDA to move faster.

Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, said in a statement ahead of Wednesday’s update that she wants FDA to include a non-peer-reviewed analysis released last year by the conservative Ethics and Public Policy Center, which critics have called “flawed” and “junk science.”

FDA said it is reviewing data contained within Sentinel, a national database partnered with insurers, hospitals, electronic health records and academic institutions, among other groups.