Govind TekaleIf you get mifepristone through a telehealth visit or by mail, or prescribe it that way, the FDA's latest filing does not change those rules right now. The agency says it will complete its safety review of the abortion pill by March 2027, and Reuters reports the review could lead to changes. Here is what is being reviewed, what stays the same for now, and what to watch next.
The US Food and Drug Administration said in a filing in Louisiana federal court late on Wednesday, October 7, that it expects to receive results of a study on mifepristone's safety risks in December and will issue a report after interpreting them. The agency plans to complete the review by March 2027, according to Reuters. Mifepristone is the first drug in a two-drug regimen, followed by misoprostol, used to end a pregnancy within the first 10 weeks. The FDA approved it in 2000.
For now, the filing does not change the current federal rules. Under them, mifepristone can be prescribed remotely and dispensed by mail, so patients, clinics and pharmacies can keep using those options unless a court order or FDA action changes that. The review could lead the FDA to repeal the 2023 rule that eased access, Reuters reported. Access also depends on state law, which the federal timeline does not change. Nearly half of US states have adopted partial or total abortion bans since 2022.
Behind the March 2027 Timeline: What the FDA Is Reviewing
According to the filing, the FDA's safety review compares a sample of 100,000 women who used mifepristone with a comparison group who had surgical abortions. The agency said it is running a statistical analysis to look for safety risks that have not yet been identified. Most major medical groups, and the FDA at various times since 2000, have said mifepristone is safe and effective when taken as directed and that serious adverse events are rare.
The FDA also said it is weighing petitions urging a range of actions, including bringing back an in-person dispensing requirement that the 2023 rule repealed. Reuters reported the agency could also reconsider its original 2000 approval, though that would be a difficult and lengthy process.
Medication abortion accounted for 65% of US abortions in 2023, according to the Guttmacher Institute, an abortion rights advocacy group.
Wednesday's filing was made in a lawsuit by Louisiana challenging the mail-order rule. That case has been paused pending the FDA review, as has a separate, broader lawsuit by Texas and Florida. A third lawsuit by Republican-led states is pending in Missouri federal court. Those court challenges are waiting on the FDA's report.
When will the FDA complete its abortion pill review, and is the pill still available? The FDA says it will complete its mifepristone review by March 2027 and expects study results in December. For now, mifepristone remains FDA-approved nationwide, and the current federal rules, which allow remote prescribing and mail dispensing, remain in effect. Whether a patient can obtain the pill depends on state law.
The FDA expects the study results in December and says it will complete its review by March 2027. Check back for updates.
For primary documentation, see the FDA information about mifepristone and the agency’s REMS database. Related Karmactive coverage examines federal administrative rulemaking and court standing requirements.
