FDA Tells a Federal Court Its Mifepristone Safety Review Will Run to March 2027, Ruling Out Changes Before the Midterms

In a court-ordered status report filed on 7 October in the Western District of Louisiana, the FDA said its safety review of mifepristone, the drug used in most US medication abortions, is “on track to obtain study results by mid-December 2026.” It expects to finish its report “not later than March 2027,” and only then decide whether to change how the drug can be prescribed.

That means no federal change before the 3 November election. Telehealth prescribing and mail delivery, made permanent by the FDA in 2023, stay in effect.

The review

Health and Human Services Secretary Robert F. Kennedy Jr. ordered the review. It uses what the FDA calls a “statistical data mining method” on adverse event data from health networks and insurers. The agency is also weighing several citizen petitions asking for restrictions.

The FDA has approved mifepristone since 2000. Its label and the risk management programme governing who can prescribe it have been loosened several times, most recently in 2023, when retail pharmacies were allowed to dispense it.

The cases

Louisiana, Missouri and Florida have sued to roll back the 2023 changes. The administration has asked the courts to pause those suits while the review runs. In September a Fifth Circuit panel questioned whether Louisiana has standing to sue. The Supreme Court has blocked changes to the drug’s availability until it hears the case again. In 2024 it threw out an earlier challenge by anti-abortion doctors for lack of standing.

Reactions

Groups on both sides are unhappy. Marjorie Dannenfelser of SBA Pro-Life America called the update “alarming” and noted the review has already taken 20 months. Students for Life called it “insufficient.” Reproductive Freedom for All called the review a political stunt.

Why it matters

Mifepristone shows how a regulatory question has become a political one. The FDA’s leadership has changed repeatedly this year, as covered in our FDA post, and an agency without a confirmed commissioner is running a review that both parties will read as a signal. Pushing the decision past the midterms avoids a pre-election fight. It doesn’t settle what the FDA will do in 2027, or whether its method will hold up in court if it restricts a drug it has approved for a quarter of a century.