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News
The FDA's safety review of mifepristone, the most widely used abortion pill in the U.S., won't be completed until early 2027. A safety study is expected by mid-December, with a final report due no later than March 2027 — after which the agency will decide whether to impose new restrictions. The review was ordered by Health Secretary RFK Jr. amid pressure from anti-abortion groups.
The FDA has confirmed that its court-ordered safety review of mifepristone — the nation's most commonly used abortion pill — will stretch into next year, with a final report not expected until March 2027. The review was initiated under Health Secretary Robert F. Kennedy Jr. following pressure from anti-abortion groups and their congressional allies who have been pushing the Trump administration to restrict the drug's use.
The FDA says it will complete a safety study by mid-December, using a "statistical data mining method" to scan an electronic database of medical injuries and drug side effects from major health networks and insurers. After reviewing the findings, the agency will determine whether to impose new restrictions or other changes to how mifepristone is prescribed and distributed.
Mifepristone, approved by the FDA in 2000, is used alongside misoprostol and accounts for the most common form of abortion in the U.S. The drug has repeatedly been reaffirmed as safe and effective, and restrictions on it have been loosened over the years — including a 2021 decision allowing online prescriptions and mail delivery.
Key Takeaways:
Why it matters: The outcome of this review could reshape abortion access across the U.S., particularly in states where mail-order mifepristone has allowed women to circumvent state-level abortion bans. Clinicians and patients alike are watching closely.
