FDA abortion pill safety review extends into 2027

The Food and Drug Administration expects to finish studying the safety of mifepristone, the nation’s main abortion pill, by mid-December but will not issue its report until March 2027 at the latest, according to a court filing. The timetable drew immediate criticism from abortion opponents seeking new restrictions on the drug.

The filing, submitted by the Justice Department in a Louisiana lawsuit, provides the first substantive update on a review ordered by Health Secretary Robert F. Kennedy Jr. Once the report is complete, the FDA will decide whether changes to the rules governing mifepristone are needed.

“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 filing said. REMS, or Risk Evaluation and Mitigation Strategy, is the program that sets restrictions on the drug’s use.

Mifepristone was approved in 2000. The FDA has repeatedly reaffirmed its safety and effectiveness while easing restrictions, including a requirement that it be dispensed in person. Used with a second drug, misoprostol, it is part of the most common form of abortion in the United States.

The agency said it is using a “statistical data mining method” to look for “unknown safety concerns” in an electronic database of reports of medical injuries and drug side effects from major health networks and insurers, CBS News reported. It is also considering petitions seeking changes to how mifepristone is prescribed and distributed.

Abortion opponents have focused on the decision to allow prescriptions online and delivery by mail, a change introduced in 2021 during the COVID-19 pandemic and made permanent in 2023 under President Joe Biden. Louisiana argues in its lawsuit that mail delivery undermines its abortion ban. Talking Points Memo reported that the state also says it incurs costs for Medicaid patients with complications related to the drug.

A federal judge ordered the FDA to provide the update in that case. Last month, a three-judge panel of the 5th U.S. Circuit Court of Appeals questioned whether Louisiana has legal standing to challenge the agency’s oversight of mifepristone, CBS News reported. The Supreme Court has blocked changes to the drug pending further review of the case, the outlet reported.

Gavin Oxley of Americans United for Life called the timetable a lack of “true leadership” by Trump administration officials. “The administration continues to find itself on the wrong side of women’s health, clearly uninterested in mitigating the ongoing harms caused by the abortion pill,” he said.

The FDA has not announced whether it will change access to mifepristone. Its filing says it expects to provide a further update on the review’s timetable when the report is completed in March 2027.