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Federal judge in Hawaii rules FDA violated the law by restricting access to abortion medication

Judge Otake found the FDA unlawfully kept restrictions on mifepristone without proper explanation, ordering reconsideration of ignored evidence under the Administrative Procedure Act.

  • On Thursday, U.S. District Judge Jill Otake ruled the U.S. Food and Drug Administration violated the law by restricting access to mifepristone, finding the 2023 limits lacked a reasoned explanation.
  • The ACLU argues in a lawsuit that the FDA has overly restricted a safe medication since 2017 across Republican and Democratic administrations.
  • The FDA's current restrictions include special certification for prescribers and pharmacies and a counseling form for patients, while the earlier in-person pickup requirement was removed to allow mail delivery of medication.
  • The ruling instructs the U.S. Food and Drug Administration to reconsider evidence it allegedly disregarded, but the restrictions remain in place for now, the ACLU says they disproportionately affect patients who are low-income or live in rural areas, while Justice Department attorneys did not immediately comment.
  • The decision comes as mifepristone, approved 25 years ago, has decades of safety evidence from FDA scientists but remains regulated more heavily than 99 percent of prescription drugs.
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Federal judge in Hawaii rules FDA violated the law by restricting access to abortion medication

A federal judge in Hawaii has ruled that the U.S. Food and Drug Administration violated the law by imposing restrictions on a medication used for abortions and miscarriage management.

·United States
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U.S. News broke the news in New York, United States on Thursday, October 30, 2025.
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