Federal Court Rules that FDA’s Restrictions on Medication Abortion are Unlawful, Vindicating Reproductive Health Experts

Affiliate: Ƶ of Hawaii
October 30, 2025 4:30 pm

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HONOLULU — Today, a federal district court that the Food and Drug Administration’s (FDA) imposition of medically unnecessary restrictions on the medication abortion pill mifepristone violated federal law. While this ruling does not change patients’ ability to access medication abortion in the near term, it affirms the FDA’s legal obligation to consider the overwhelming evidence of mifepristone’s safety and not to impose restrictions that unduly burden patient access to this essential medication.

The court's finding that the agency failed to justify its restrictions on access to mifepristone comes as the Trump administration appears to be gearing up to make it even harder for people to get the medication nationwide.

Earlier this year, the Trump administration announced that the FDA is conducting a new review of its mifepristone regulations. Secretary Kennedy has indicated that the review centers on a junk science paper, issued by a Project 2025 sponsor, that purposefully distorts the excellent safety record of medication abortion. This paper is a six-page, non-peer-reviewed document that has been for its lack of transparency and gravely flawed methodology. Nevertheless, in a to anti-abortion state attorneys general on Sept. 19, 2025, Secretary Kennedy doubled down on the publication’s importance, citing this propaganda as a “recent stud[y] raising concerns about the safety of mifepristone as currently administered.”

Under today’s ruling, the FDA will need to consider the wealth of peer-reviewed evidence proving mifepristone’s safety, including when delivered by telemedicine, as well as how FDA’s restrictions burden patient access.

“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 Ƶ Reproductive Freedom Project. “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. Now, Secretary Kennedy is using more junk science to lay the groundwork for making it even harder to get a medication abortion. Today’s decision is a crucial reminder that the courts and the medical community won’t sit by while the Trump administration trashes our healthcare and our reproductive freedoms.”

“I am pleased the Court recognized that the FDA’s extreme restrictions on mifepristone are not grounded in logic or science. 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,” said Heidi Purcell, M.D. “In the Hawaiian islands, 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.”

“Today’s decision is a win for science, and reinforces what decades of research has shown -- there is no credible evidence to justify the current burdensome regulations on mifepristone,” said Amanda Dennis, DrPH, MBE, executive director, Society of Family Planning. “As the anti-abortion movement’s strategy of co-opting science to advance medication abortion restrictions intensifies, today’s ruling is a crucial reminder that healthcare policy must be informed by evidence, not ideology.”

“As front-line physicians who provide preventive and primary care for the whole family, family physicians fight for patient access to safe and effective treatments,” said Lisa Folberg, MPP, chief executive officer of the California Academy of Family Physicians. “The FDA's needless restrictions on mifepristone make our jobs harder without any safety benefit. We appreciate that the court recognized how FDA failed to consider the toll its restrictions take on physicians trying to provide a safe and effective medication to their patients. For eight years, CAFP has been in court fighting for an FDA policy on medication abortion grounded in science, not politics or stigma. This decision is a step in the right direction.”

For over a decade, medical authorities and reproductive health experts have advocated for lifting the FDA’s medically unnecessary restrictions on mifepristone. The Ƶ first filed this case, Purcell v. Kennedy (formerly Chelius v. Becerra) on behalf of preeminent health care associations and an individual family medicine doctor in 2017.

In 2021, this litigation the FDA to reconsider its in-person dispensing requirement for mifepristone in light of the significant evidence that mifepristone is just as safe when dispensed through a pharmacy and that the in-person requirement severely burdened patient access. While the FDA suspended and then formally eliminated its telemedicine restrictions for mifepristone, it continued to single out mifepristone prescribers, pharmacists, and patients with medically unnecessary restrictions that severely limit patients’ ability to access medication abortion. Indeed, despite abortion opponents’ attempts to paint the FDA as inadequately restrictive, the evidence in this case showed that the FDA already regulates mifepristone more heavily than 99 percent of prescription medications.

If the FDA’s mifepristone regulations are made more stringent, whether through court order or Trump administration policy changes, access to abortion will be further out of reach for patients across the nation.

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