Abortion drug safety review will be completed by March, US FDA says

The Trump administration plans to complete a review of the abortion drug mifepristone by March 2027, according to a court filing, paving the way for potential changes that could limit access ‌to the pills.

The US Food and Drug Administration in a filing in Louisiana federal court late on Wednesday said it expects to receive the results of a study on the drug's safety risks in December and will issue a report after interpreting them. The review could lay the groundwork for the FDA to ‌repeal regulations that eased access to mifepristone, such as a 2023 rule allowing the drug to be prescribed remotely and dispensed through the mail. The agency ‌could also reconsider its initial approval of mifepristone in 2000, though that would be a difficult and lengthy process.

Wednesday's filing was made in a lawsuit by the state of Louisiana challenging the mail-order rule. The case has been paused pending the FDA review, along with a separate, broader lawsuit by Texas and Florida. A third lawsuit by Republican-led states challenging mifepristone regulations is ⁠pending in Missouri ​federal court. The office of Louisiana Attorney ⁠General Liz Murrill, a Republican, did not immediately respond to a request for comment on the new filing.

Medication abortion is a two-drug regimen consisting of mifepristone followed by misoprostol used to terminate ⁠a pregnancy within the first 10 weeks. Most major medical groups, and the FDA at various times since the medication's 2000 approval, have said that mifepristone is safe and effective ​when taken as directed and that serious adverse events are rare.

The use of abortion drugs has surged since the US Supreme Court in 2022 ⁠overturned Roe v. Wade, the 1973 decision that legalized abortion nationwide, and nearly half of US states have since adopted partial or total abortion bans. Medication abortion accounted for 65% of US abortions ⁠in ​2023, according to the Guttmacher Institute, an abortion rights advocacy group. Along with the lawsuits against the FDA, states with abortion bans have responded to the surge by suing and indicting doctors and groups that provide abortion pills and challenging laws in other states that shield providers from out-of-state criminal investigations ⁠and civil liability.

The FDA in Wednesday's filing said its safety review involves comparing a sample of 100,000 women who used mifepristone with a comparator group who ⁠received surgical abortions. The agency said it ⁠is running a statistical analysis to detect safety risks that have not yet been identified. The FDA said it is also weighing a number of petitions urging the agency to take a range of actions, such as reinstating an ‌in-person dispensing requirement that ‌was repealed in the 2023 rule.