A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six months to provide the court with an update on the investigation.
The FDA is once again studying the safety of the abortion pill mifepristone just days after a federal Louisiana judge temporarily allowed the dispensing of the drug through mail.
“FDA continues to work on the collection of the robust and timely data that is necessary for a well-controlled study,” the agency wrote in an April 8 update to its website. The analysis will help the regulator decide whether it needs to make “substantive” changes to its Risk Evaluation and Mitigation Strategies for mifepristone, though it is unclear what such changes could look like.
“The agency is taking care to do this study properly and in the right way,” the FDA wrote, nevertheless adding that it wants to wrap up the study “as soon as possible.” Analyses such as these take “approximately a year or more” in academic settings, the regulator claimed, noting that “the current agency plan is to have this study done sooner than that.”
This new safety study comes a day after a Louisiana court blocked an attempt by Liz Murrill, Louisiana’s Attorney General, to prevent mifepristone from being dispensed to patients by mail. In a 37-page ruling on April 7, Judge David Joseph granted the FDA’s motion to press pause on the case while it conducts an assessment of mifepristone’s safety.
“The equities and the public interest weigh heavily in favor of FDA completing the job that the law requires it to do,” Joseph wrote. “At this juncture, it is the completion of FDA’s promised good faith, evidence-based, and expeditious review [of mifepristone’s safety] that this court finds to be in the public interest.”
Joseph, who was appointed by President Donald Trump, gave the FDA six months to provide the court “with the status of its review . . . and any updated timeframe for completion.”
Mifepristone is a progesterone blocker that is used to terminate pregnancies alongside another drug called misoprostol. It can also be used to treat high blood sugar in Cushing’s syndrome. Because of its role in inducing abortion, mifepristone has attracted controversy, particularly since federal protection of abortion rights was eliminated by the Dobbs v. Jackson Women’s Health Organization Supreme Court decision in 2022. In November 2022, for instance, the Alliance for Hippocratic Medicine filed a lawsuit against the FDA, asking to agency to pull its approval of the pill.
Then, in April 2023, Texas judge Matthew Kacsmaryk issued a preliminary injunction that blocked sales of mifepristone. This order kicked off a legal back-and-forth, at one point drawing an open letter from more than 480 biopharma leaders, and made it all the way to the Supreme Court. The letter called Kacsmaryk’s decision an “act of judicial interference” made “without regard for science or evidence.”
In June 2024, the High Court ruled to keep mifepristone available.
The fight over abortion access continued into 2025. In April, advocacy group Ethics and Public Policy Center published a report alleging that serious adverse events have developed in more than 10% of women on mifepristone. The report led health secretary Robert F. Kennedy, Jr. in May to tell the FDA to review its safety policies around the drug.
The anti-abortion report was “fundamentally, fatally flawed,” according to an open letter from 53 biotech executives and investors that asked the FDA to maintain access to mifepristone.
Editor’s note (April 10): The headline has been updated to better describe mifepristone as an abortion pill.
