Mifepristone has been on the American market since 2000. The FDA has reaffirmed its safety and effectiveness repeatedly over the years, and has spent much of that time loosening, not tightening, the rules around it — most recently dropping the requirement that the pill be dispensed in person. Taken with a second drug, misoprostol, it makes up the most common form of abortion in the country. None of this has kept it from becoming Washington’s biggest regulatory fight. Since President Trump returned to office, anti-abortion groups and their allies in Congress have pushed the administration to revisit the pill in hopes of restricting its use, and Health Secretary Robert F. Kennedy Jr ordered a reevaluation. On Wednesday, CBS News reported, the FDA finally said how that reevaluation is going — in a court-ordered filing made late in the day, which is how agencies prefer to deliver news they expect people to dislike.
The answer: slowly. The FDA expects to complete its safety study of the pill by mid-December, and to deliver a report on the findings “no later than March 2027.” Only after that will the agency decide whether to impose new restrictions or other changes on the drug’s use. The update was directed by a federal judge in a case brought by the state of Louisiana, one of several state lawsuits over mifepristone now winding through the courts.
Notably, the fury at this timeline is coming from the side that wants the drug restricted. Gavin Oxley of Americans United for Life, an anti-abortion group, called it a failure of “true leadership” by Trump administration officials. “The administration continues to find itself on the wrong side of women’s health, clearly uninterested in mitigating the ongoing harms caused by the abortion pill,” he said. The usual script of drug-approval fights — patient advocates demanding speed, regulators demanding caution — has been flipped: the FDA’s most eager customers here are the people hoping it finds something wrong.
As for how the agency is looking, the filing describes a “statistical data mining method” being used to discover “unknown safety concerns” the drug may have, drawing on an electronic database that collects reports of medical injuries and drug side effects from major health networks and insurers. There is a certain poetry in that phrase. A drug that has been approved for a quarter century, repeatedly reaffirmed and prescribed by mail nationwide is now the subject of a hunt for concerns that are, by definition, the ones nobody has noticed yet. The agency said it is also weighing a number of petitions proposing changes to how mifepristone is prescribed and distributed.
Everyone in this fight understands that the real target is not the pill’s chemistry but its logistics. Abortion opponents have concentrated on a 2021 decision allowing doctors to prescribe mifepristone online and send it through the mail during COVID, a policy made permanent under President Joe Biden in 2023. That decision had the practical effect of undermining state abortion bans, since women in states where abortion is illegal can receive the drug by mail.
Which is precisely Louisiana’s theory: that mail delivery of mifepristone undermines the state’s abortion ban. Last month, though, a three-judge panel of the 5th U.S. Circuit Court of Appeals questioned the merits of the case, including whether Louisiana even has legal standing to challenge the FDA’s oversight of the drug. And any ruling from the 5th Circuit would not immediately change anything, because the Supreme Court has blocked changes to the drug’s availability until it sees the case again. So the litigation, like the review, runs on a long clock.
What could the review actually do? Asked in 2025, CBS News medical correspondent Dr. Celine Gounder said withdrawing approval entirely would be an extraordinary step that would draw immediate legal challenges. More plausible, depending on the findings: making access harder by limiting availability through telehealth or by mail, or restricting prescribing to physicians rather than the physician assistants and nurses who can currently prescribe it.
So the shape of the next several months is set. A safety study of a 26-year-old drug, commissioned to find what a quarter century of surveillance didn’t, finishes in December; its conclusions emerge three months later; and the decisions land after that, whenever they land. Whether March 2027 is a scientific deadline or a scheduling choice is the question both sides now get to argue about.