Federal regulators announced on Oct. 7 that a safety review of the abortion pill mifepristone will extend into 2027, with a final report expected no later than March 2027. The FDA’s study is currently slated for completion by mid-December 2024, though officials noted additional time will be required to review findings and draft a report.
The FDA’s ongoing evaluation stems from a court-ordered update in a legal case involving Louisiana, which has challenged the agency’s 2023 decision to remove the requirement that mifepristone be dispensed in person. The agency is also analyzing data from the Sentinel Initiative, a collaborative project with partners such as Kaiser Permanente and the University of Florida College of Pharmacy, to assess the drug’s safety profile. Additionally, the FDA is reviewing citizen petitions that cite over 170 articles and publications related to mifepristone.
The two-drug regimen of mifepristone and misoprostol remains the most common form of abortion in the U.S. The FDA has historically maintained that mifepristone is safe and effective, though the agency’s latest review could lead to changes in how the drug is accessed. A federal judge overseeing the Louisiana case previously noted that the FDA loosened restrictions despite citing a “dearth of information”, but declined to block the change, deferring to the agency’s authority. The judge directed the FDA to file a status report within six months.
The review process comes amid shifting political and legal landscapes. The Supreme Court’s 2022 decision overturning Roe v. Wade removed federal protections for abortion rights, prompting states to enact varying restrictions. Louisiana’s lawsuit argues that mail delivery of mifepristone undermines its state abortion ban, one of several ongoing legal challenges to the drug’s distribution.
The FDA has not indicated whether its findings will result in new restrictions on mifepristone. The agency’s next update is expected in a court filing within six months, as ordered by the federal judge.