Hawaiʻi Federal Court Rules that FDA’s Restrictions on Medication Abortion are Unlawful

HONOLULU, HI — U.S. District Judge Jill Otake held, in an October 30 ruling, 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.

Wookie Kim, ACLU of Hawaiʻi Legal Director who served as co-counsel in the case shared, “We are grateful the Court held FDA accountable for failing to follow the law in restricting access to medication abortion. This ruling has special meaning here in Hawaiʻi, 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.”

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 six-page, non-peer-reviewed paper that has been denounced by more than 260 expert researchers for its lack of transparency and gravely flawed methodology. In a letter 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.”

Instead, under yesterday’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. The court’s findings on the FDA’s scientific and legal obligations stand in stark contrast to Secretary Kennedy’s statement that the ultimate decision about the FDA’s mifepristone policy will “go through the White House, through President Trump.”

“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,” said Julia Kaye, senior staff attorney with the ACLU Reproductive Freedom Project

“This decision is a victory, not only for reproductive freedom, but for science over paternalism, shared Emily Hills, senior staff attorney at the ACLU of Hawaiʻi. “Evidence and decades of experience have shown that mifepristone is no more dangerous than many other prescription medications that are less heavily regulated. The Court rightly rejected the FDA's "informational gerrymandering" and “unexplained logical leaps” to conclude that the FDA’s burdensome regulation of mifepristone was unlawful.”

For over a decade, medical authorities and reproductive health experts have advocated for lifting the FDA’s medically unnecessary restrictions on mifepristone. The American Civil Liberties Union 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 prompted 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.

“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 Hawaiʻi can access essential medications, not throwing up needless barriers to care.”

Even as medical experts continue to fight against these burdensome restrictions, anti-abortion state attorneys general are in multiple federal courts seeking even greater restrictions on medication abortion. 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.