FDA to draft mifepristone safety review by March 2027

The Food and Drug Administration expects to complete a draft report of its safety review of mifepristone by March 2027, according to an Oct. 7 court filing. In a status update for the U.S. District Court for the Western District of Louisiana, the agency stated it is on track to obtain study results by mid-December 2026 to begin its review.

The filing stems from a lawsuit by Louisiana seeking to end the Biden administration policy that allows the drug to be distributed by mail. Missouri and Florida have filed similar challenges. The Trump administration has asked judges to pause these lawsuits while the safety review is conducted, leaving current regulations in place for the time being.

Mifepristone is used for first trimester abortions and certain miscarriage care protocols. Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, called the update alarming in an Oct. 7 statement.