Hawaiʻi federal court rules that restrictions on medication abortion are unlawful

In a ruling on Oct. 30, U.S. District Judge Jill Otake determined that the Food and Drug Administration’s (FDA) imposition of medically unnecessary restrictions on the medication abortion pill, mifepristone, violated federal law.

The court’s decision that the agency failed to justify its restrictions on access to mifepristone comes as the Trump administration appears to be preparing to make it harder for people to obtain the medication nationwide.

Earlier this year, the Trump administration announced that the FDA is conducting a new review of its mifepristone regulations. U.S. Secretary of Health and Human Services Robert F. Kennedy has indicated that the review centers on a six-page, non-peer-reviewed paper that has been criticized by more than 260 expert researchers for its lack of transparency and flawed methodology.

In a letter to anti-abortion state attorneys general on Sept. 19, Kennedy emphasized the publication’s significance, citing it as a “recent stud[y] raising concerns about the safety of mifepristone as currently administered.”

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

The court’s findings on the FDA’s scientific and legal obligations contrast with Kennedy’s statement that the ultimate decision about the FDA’s mifepristone policy will “go through the White House, through President Trump.”

While the Oct. 30 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 impose restrictions that unnecessarily burden patient access to this essential medication.

“We are grateful the court held the FDA accountable for failing to follow the law in restricting access to medication abortion,” said Wookie Kim, Hawaiʻi Legal Director of the American Civil Liberties Union (ACLU). “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.”

For over a decade, medical authorities and reproductive health experts have advocated for lifting the FDA’s medically unnecessary restrictions on mifepristone. The ACLU first filed the case, Purcell v. Kennedy (formerly Chelius v. Becerra), on behalf of leading 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.

“This decision is a victory not only for reproductive freedom but for science over paternalism,” said 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.”

While the FDA suspended and then formally eliminated its telemedicine restrictions for mifepristone, it continued to impose medically unnecessary restrictions that severely limit patients’ ability to access medication abortion.

According to Dr. Heidi Purcell, a women’s health care provider in Hawaiʻi, the court decision should prompt the FDA to lift its medically unjustified restrictions on medication abortion; however, the Trump Administration may worsen the situation.

“In the Hawaiian islands, where patients may live a flight away from the nearest provider, losing a telemedicine option for mifepristone would be devastating,” Purcell said. “The FDA should be working to ensure that patients in rural and underserved areas like Hawaiʻi can access essential medications, not creating 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.

“Despite decades of real-world experience and mountains of evidence proving mifepristone’s safety, the FDA regulates this medication more heavily than 99% of prescription drugs,” said Julia Kaye, senior staff attorney with the ACLU Reproductive Freedom Project. “Today’s decision is a crucial reminder that the courts and the medical community won’t sit by while the Trump administration harms our healthcare and our reproductive freedoms.”