FDA Says Review of Main Abortion Pill Won’t Finish Until Next Year

The Food and Drug Administration announced that its safety review of the nation’s primary abortion pill will stretch into next year. The agency provided a court‑ordered update in a filing on Wednesday, the first detailed progress report since Health Secretary Robert F. Kennedy Jr. ordered the reevaluation. Mifepristone, first approved in 2000, has been repeatedly deemed safe and effective, and the FDA has already eased several restrictions, including dropping the in‑person dispensing rule. Anti‑abortion groups and supportive members of Congress have pressed the administration for a new review since President Donald Trump returned to office. The FDA said it expects to finish its safety study by mid‑December and will issue a report no later than March 2027, after which it may consider new limits or other changes. Gavin Oxley of Americans United for Life called the move a lack of “true leadership” and said the administration is on the wrong side of women’s health. The two‑drug regimen of mifepristone and misoprostol remains the most common abortion method in the United States. A federal judge ordered the latest update in a Louisiana case that argues mail delivery of mifepristone defeats the state’s abortion ban. The case is part of several lawsuits challenging the drug’s use. A 5th Circuit panel recently questioned Louisiana’s standing, and the Supreme Court has blocked any changes until it reviews the case again. The FDA said it is using a statistical data‑mining method on a large electronic database of medical injury and side‑effect reports to spot any unknown safety concerns. In addition, the agency is reviewing petitions that propose changes to how mifepristone is prescribed and distributed. Opposition groups focus on the 2021 decision that allowed online prescribing and mail delivery during the COVID‑19 pandemic, a rule that President Joe Biden made permanent in 2023 and that has weakened many state bans.

Context

The review reflects a broader clash between federal health regulators and state‑level attempts to limit abortion access. The FDA’s findings could shape how the pill is prescribed, mailed, or sold across the country.