The U.S. Food and Drug Administration told a federal court Wednesday that it expects to finish its safety review of mifepristone by March 2027. The filing was made in the U.S. District Court for the Western District of Louisiana, Lafayette Division, in a case challenging the FDA’s telehealth rules for the abortion pill.
The FDA said it is “on track to obtain study results by mid-December 2026.” The agency said it will then review the results, evaluate and interpret them, and draft a report. The FDA also said it is reviewing the Mifepristone REMS Program, including citizen petitions asking the agency to restore safeguards that were removed, such as an in-person dispensing requirement.
Mifepristone remains on the market during the review. It also remains available through mail-order while the litigation continues. In May, a federal appeals court granted Louisiana’s request to reinstate a nationwide requirement that mifepristone be dispensed in person, but the U.S. Supreme Court quickly blocked that decision while the case proceeds.
U.S. District Judge David Joseph previously stayed the case while the FDA conducts its review, but ordered the agency to file a status report within six months of his April 7 order. He wrote that if the agency does not complete its review and make any needed changes to the REMS within a reasonable timeframe, the court’s analysis “will inevitably change.”
The abortion pill regimen is now the most common method of abortion in the United States. More than 7.5 million unborn children have died through the regimen since the FDA approved mifepristone in 2000. The next question is whether the FDA’s review will restore basic safeguards for women and unborn children, or leave mail-order abortion pills in place nationwide.
