The FDA expects to complete its safety review of mifepristone, the abortion-inducing drug commonly used with misoprostol, by March 2027, according to an October 7 court filing in a lawsuit brought by Louisiana.
The agency expects to finish a related study by mid-December and submit its findings no later than March. Only after reviewing the results will the FDA decide whether changes to the drug’s prescribing or distribution rules are necessary.
The review includes an analysis of reported medical injuries and drug side effects, as well as petitions seeking changes to current requirements. The timeline means no new restrictions are expected before the review is completed.
Pro-life organizations have criticized the delay and called for reinstating the in-person dispensing requirement removed in 2021, which allowed abortion drugs to be prescribed remotely and shipped by mail.