A Department of Justice (DOJ) brief filed in Louisiana v. Food and Drug Administration (FDA), a case seeking to restrict access to medication abortion, confirmed that FDA is in the process of “reviewing” mifepristone’s Risk Evaluation and Mitigation Strategy (REMS), “including a new study it is undertaking.” FDA is actively “work[ing] on the collection of the robust and timely data that is necessary for a well-controlled study with adequate statistical power.” 

The timing of the current review remains unclear, although FDA estimates it will take less than a year (presumably from September 2025, when FDA officially announced the review). DOJ, representing FDA, will be required to file a status report on the review’s progress no later than October 7, 2026.

Learn more about Louisiana v. FDA and other threats to mifepristone here.