FDA Mifepristone Review Set to Continue Into March 2027

The Food and Drug Administration plans to complete its safety review of mifepristone by March 2027, according to a court filing, and will decide afterward whether to change rules governing the medication. The filing does not announce an immediate change to access rules. Government lawyers told a federal court in Louisiana that the FDA expects study results by mid-December 2026. The agency expects to interpret the results and issue a report no later than March 2027, then determine whether changes to its mifepristone safety program are necessary. The timeline was provided in a status update filed October 7 in a lawsuit brought by Louisiana. The FDA said it is using a statistical analysis of health-system data to look for safety concerns that may not have been identified previously. The review also includes petitions seeking changes to how the drug is prescribed and distributed. The filing describes a study comparing outcomes among roughly 100,000 mifepristone users with a group who received surgical abortions. Mifepristone is used with misoprostol in medication abortions.