A federal judge in Honolulu has ordered the U.S. Food and Drug Administration (FDA) to follow science and the law when reconsidering the 2023 restrictions on an abortion pill that has been deemed safe for more than a decade.
While the order does not change any of the current restrictions, it requires the agency to reevaluate the requirement that providers of mifepristone sign a form certifying their qualification and confirming that they have reviewed the patient agreement form with the patient before sending the medication to prescribing pharmacies. Given the overwhelming evidence of the pill’s safety, both the patient agreement form and the pharmacy certification requirement were challenged as unnecessary.
In an order issued Thursday, U.S. District Judge Jill A. Otake wrote that the 2023 Risk Evaluation and Mitigation Strategy (REMS) was “unlawful under the Administrative Procedure Act” and remanded the matter back to the FDA with instructions to properly address the statutorily mandated factors and consider relevant evidence that the FDA allegedly disregarded.
The American Civil Liberties Union (ACLU) had asked Judge Otake for summary judgment in a 2017 case brought by a Kauai-based physician and two nonprofits. The lawsuit challenged the requirements for prescribing and using mifepristone as excessive, given the drug’s established safety profile.
This request came after the Trump administration announced it would review the drug with an eye toward potentially restricting its use. The ACLU first filed the case in 2017 on behalf of Dr. Heidi Purcell, a physician affiliated with the Society of Family Physicians and the California Academy of Family Physicians, against U.S. Department of Health and Human Services Secretary Robert F. Kennedy and FDA Commissioner Martin A. Makary.
“I am pleased the Court recognized that the FDA’s extreme restrictions on mifepristone are not grounded in logic or science,” said Purcell in a statement. “But while this decision should be a call to action for FDA to finally lift its medically unjustified restrictions on medication abortion, I fear the Trump Administration is gearing up to make things worse.”
Purcell added, “In Hawaii, where patients may live a flight away from the nearest provider, losing a telemedicine option for mifepristone would be devastating. The FDA should be working to ensure that patients in rural and underserved areas like Hawaii can access essential medications, not throwing up needless barriers to care.”
Background on Mifepristone
The FDA first approved mifepristone, a pill used in the majority of medication abortions, in combination with misoprostol in 2000. Mifepristone works by blocking the effect of a hormone necessary for pregnancy, while misoprostol causes contractions and bleeding that empty the uterus.
The FDA requires certain drugs to undergo a “Risk Evaluation and Mitigation Strategy” (REMS) to ensure safe usage, and mifepristone is subject to such requirements.
Judge Otake concluded that the FDA violated the law by failing to provide a “reasoned explanation for its restrictive treatment of the drug.” This failure was compounded by the agency’s decision to limit the scope of information it considered during its evaluation.
“More specifically, the FDA neglected to consider certain required statutory factors and generally failed to sufficiently explain the logic behind any reasoning it did provide,” Otake wrote.
Next Steps
While Judge Otake’s order maintains the current restrictions on mifepristone, it sends the requirements back to the FDA for a review consistent with her instructions.
Wookie Kim, Legal Director of the ACLU of Hawaii and co-counsel in the case, expressed gratitude for the ruling. “We are thankful that Judge Otake held the FDA accountable for failing to follow the law in restricting access to medication abortion,” Kim said.
She added, “This ruling has special meaning here in Hawaii, where patients often face geographic and financial barriers that make accessing reproductive care especially difficult. It also affirms that decisions about reproductive freedom must be guided by science, not politics.”
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