The Food and Drug Administration said on April 10 it is conducting a new review of the abortion pill mifepristone’s safety, following a recent decision by a federal judge in Louisiana that temporarily allows the drug to be dispensed through the mail.
The review comes as debates over abortion access continue across the country. The FDA's assessment will help determine if any changes are needed to its Risk Evaluation and Mitigation Strategies for mifepristone, though what those changes might be remains unclear.
In an update posted to its website on April 8, the agency wrote, “FDA continues to work on the collection of the robust and timely data that is necessary for a well-controlled study.” The FDA also said it aims to complete this study “as soon as possible,” noting that similar analyses usually take about a year or more in academic settings but adding, “the current agency plan is to have this study done sooner than that.”
This new analysis follows an April 7 ruling by Judge David Joseph, who granted the FDA’s request to pause litigation while it conducts its review. Joseph wrote, “The equities and the public interest weigh heavily in favor of FDA completing the job that the law requires it to do,” adding, “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.” He gave the agency six months to provide an update on its progress.
Mifepristone blocks progesterone and is used with misoprostol for medication abortions. It can also treat high blood sugar in Cushing’s syndrome. Its use has been controversial since federal protections for abortion were removed by a Supreme Court decision in 2022. Legal challenges have included lawsuits seeking removal of FDA approval and injunctions blocking sales—disputes which reached all the way up to the Supreme Court. In June 2024, justices ruled mifepristone should remain available.
Debate continued into 2025 when advocacy groups published reports alleging risks associated with mifepristone use. Health secretary Robert F. Kennedy Jr., responding to one such report from April 2025 claiming serious adverse events occurred in more than ten percent of women using mifepristone, instructed further policy review at FDA. However, biotech executives criticized these claims as "fundamentally, fatally flawed" and urged continued access.
