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By Carrie N. Baker | On Oct. 30, 2025, following eight years of litigation, a federal trial court in Hawaii ruled that the Food and Drug Administration (FDA) violated federal law by imposing medically unnecessary restrictions on mifepristone, which is used for early abortion. Ruling in Purcell v. Kennedy (formerly Chelius v. Becerra), the court held that the FDA has a legal obligation to fairly evaluate and weigh the decades of extensive research affirming mifepristone’s safety, noting the agency had failed to justify its restrictions on access to mifepristone.
Reproductive health advocates called the ruling a win for evidence-based regulation.
“Today’s decision is a victory for everyone who believes that our access to safe and essential medicines should be dictated by science, not politics,” said Julia Kaye, senior staff attorney with the ACLU Reproductive Freedom Project, which brought the case on behalf of medical associations and a Hawaii family physician. “Despite decades of real-world experience and mountains of evidence proving mifepristone’s safety, the FDA regulates this medication more heavily than 99 percent of prescription drugs.”
The evidence bears her out, with over 100 peer-reviewed scientific studies proving the safety of mifepristone and widespread use by over 7.5 million U.S. women for abortion care since the FDA approved the medication in 2000.
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