The decision by a federal trial court in Hawaii restores evidence to the center and demands access be considered, so that safety data, not politics, sets the rules.
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.
… medication policy must be set by medical evidence and safety data, not by partisan agendas or political interference.
The FDA’s medically unnecessary restrictions on mifepristone trace back to intense antiabortion pressure in the 1980s, shortly after the drug was developed. The FDA took over a decade to approve mifepristone—much longer than other drugs—and when they finally approved the medication in 2000, the agency imposed unusual and burdensome restrictions on the medication. For years, reproductive health advocates have urged the FDA to lift these medically unnecessary restrictions on mifepristone, arguing that medication policy must be set by medical evidence and safety data, not by partisan agendas or political interference.
Clinicians echoed the point, emphasizing that the ruling reflects the scientific consensus. “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 Dr. Amanda Dennis, executive director of the Society of Family Planning. “As the antiabortion 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.”
The stakes could not be clearer as this ruling lands amid new political pressure to restrict mifepristone. In September, Health and Human Services Secretary Robert Kennedy and FDA Commissioner Marty Makary announced the launch of a review of mifepristone in a letter to Republican attorneys general, responding to pressure from antiabortion advocates and politicians. The new FDA review rests on a single, six-page, non-peer-reviewed paper that has been denounced by more than 260 expert researchers as methodologically flawed and reaching inconsistent, scientifically unsound conclusions.
Advocates warned the new review signals a push to restrict access, with politics once again overriding evidence. “Now, Secretary Kennedy is using more junk science to lay the groundwork for making it even harder to get a medication abortion,” said Kaye. “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.”
Purcell v. Kennedy challenged the FDA for limiting access to mifepristone through a drug safety program called the Risk Evaluation and Mitigation Strategy (REMS). Under this program, the FDA requires clinicians and pharmacies who prescribe or dispense mifepristone to obtain certification with the drug manufacturer, a burdensome hurdle that prevents many from offering the medication. FDA further requires patients to sign a form acknowledging they are using the medication for an abortion, including in cases where the medication is used to treat a miscarriage. The form is then sent to the drug manufacturer, potentially comprising the privacy of patients.
Less than 3 percent of FDA-regulated drugs are subject to a REMS, which should only apply to drugs with serious risks such as addiction or liver toxicity. Most drugs in the REMS program are opioids. Mifepristone is far safer than other drugs with REMS and even safer than penicillin, Viagra or Tylenol, yet remains heavily restricted.
… the courts and the medical community won’t sit by while the Trump administration trashes our healthcare and our reproductive freedoms.
Julia Kaye, senior staff attorney with the ACLU Reproductive Freedom Project
Clinicians report that certification rules and forms hinder access rather than protect patients.
“The FDA’s needless restrictions on mifepristone make our jobs harder without any safety benefit,” said Dr. Lisa Folberg, chief executive officer of the California Academy of Family Physicians. “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.”
In 2021, the FDA suspended major parts of the REMS restrictions, removing the requirement that clinicians must dispense the medication themselves in-person and permitting pharmacies to dispense mifepristone, reducing barriers to care. This shift opened the door to telehealth abortion, which now accounts for roughly one in four of all abortions. Seeing this expansion as a threat, abortion opponents are demanding the FDA to reverse course.
With telehealth now central to access, the court set clear terms for the FDA. The court’s ruling requires the agency to consider the peer-reviewed evidence proving mifepristone’s safety, including its use via telemedicine, and to assess how the agency’s restrictions burden patient access.
In the end, the decision restores evidence to the center and demands access be considered, so that safety data, not politics, sets the rules.
“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 Dr. Heidi Purcell. “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.”
The federal court directed the FDA to reconsider the mifepristone REMS in accordance with its order and the law, and told the parties to report back within two weeks. The court’s ruling does not immediately change access to the medication, but it puts pressure on the FDA to follow the science rather than be swayed by political pressure.
