On July 23, a Virginia district court judge ordered the FDA to reconsider its restrictions on mifepristone, a highly safe and effective prescription medication for terminating early pregnancy. The judge, Robert S. Ballou, sided with reproductive health clinics in three states that argued that current restrictions are excessive, medically unnecessary, and inconsistent with federal law. The challenged restrictions are part of FDA’s 2023 risk evaluation mitigation strategy (2023 REMS).
This decision in Whole Women’s Health Alliance et al. v. FDA et al. comes at a time when various challenges to mifepristone are coming to a head. Last year, a district court in Hawaii likewise ruled that FDA failed to consider relevant evidence when maintaining or adding new restrictions, while a Washington court ruled just months earlier that FDA had met its legal obligations in issuing the 2023 REMS. Another set of lawsuits argues that FDA unlawfully lifted prior restrictions and should reinstate more severe requirements that would limit access to this medication nationwide. Notably among these cases is State of Louisiana et al. v. FDA et al., which will be argued before the Fifth Circuit Court of Appeals in early September.
All of this litigation is happening alongside – and affecting – FDA’s own “safety review” of mifepristone, a process sparked by pressure from anti-abortion advocates. Amidst this backdrop, this most recent decision in Whole Women’s Health Alliance could help ensure that FDA considers the full range of data on the decades-long safety record of mifepristone, and issues a reasonable decision, as required by law.
FDA’s Regulation of Mifepristone
After first approving mifepristone in 2000, FDA has regulated mifepristone under a REMS, a safety measure that FDA can use “to ensure that the benefits of the drug outweigh the risks.” REMS are reserved for drugs with serious risks – only about 70 of over 20,000 drugs approved by FDA are regulated under REMS. As REMS can make a drug more burdensome for healthcare systems and less accessible for patients, FDA is required by law to balance any restrictions with the specific risks of the drug.
Scientific studies and real-world experience over more than 25 years have consistently demonstrated mifepristone’s safety. As such, the FDA has modified the drug’s REMS over time largely to eliminate prior restrictions. Most recently, the FDA eliminated the REMS’ requirement that patients receive the drug directly (i.e., in person) from their provider, and created a path for pharmacies to dispense the drug. At the same time, the FDA required pharmacies to, like other health care providers, be certified before dispensing mifepristone, and maintained the requirement that patients sign a specific authorization form.
Those three REMS elements (pharmacy certification, provider certification, and the patient authorization form), are known as “Elements to Assure Safe Use” (ETASUs). FDA’s decision to maintain or impose these three ETASUs in the 2023 REMS is the focus of the Whole Women’s Health Alliance case (as well as the Hawaii and Washington cases noted above).
Whole Women’s Health Alliance v. FDA
Shortly after FDA issued the 2023 REMS, abortion providers in Virginia, Kansas, and Montana, sued the agency, arguing that the remaining restrictions “unduly burden patient access to mifepristone and are not supported by scientific evidence.” Judge Ballou sided with the abortion providers, finding that the FDA failed to consider relevant data and provide a reasonable explanation for its decision. As a result, the 2023 REMS’ policies are “arbitrary and capricious” in violation of federal administrative law.
The court first concluded that the FDA must consider three sets of statutory factors (that apply when FDA approves, modifies, or implements a REMS), when it issued the 2023 REMS. For example, the FDA must consider both the seriousness of adverse events related to a drug, as well as whether the drug could remain on the market without the particular restriction. Judge Ballou then examined the evidence that FDA used in its 2023 decision and found that FDA failed to fully consider these factors.
Specifically, the FDA limited its evidence base to “objective safety data,” thereby excluding position statements from expert major medical organizations such as ACOG and the American Medical Association. As these statements contained information that FDA was statutorily required to consider (i.e., relating to adverse events and background incidence data), Judge Ballou found that their exclusion was arbitrary and capricious. At the same time, the court found that the FDA wrongly relied on evidence outside of what it was required to consider. In particular, FDA cited publications on potential increases in providers’ volume of patients as justification for retaining the restrictions. Yet FDA failed to explain how an increase in provider volume could relate to an increased risk from mifepristone, and more importantly, how the ETASUs would mitigate that risk.
While FDA argued that it retained the remaining REMS restrictions due to a lack of evidence supporting their removal, Judge Ballou ruled that the agency had misapplied the evidentiary burden. FDA, he wrote, bears the burden to confirm that the REMS is necessary for the drug’s benefits to outweigh its risks. (The court also noted that evidence does support the removal of the remaining REMS restrictions, but FDA chose to exclude that evidence.) Regarding the three ETASUs, the FDA failed to demonstrate why standard practices to ensure that providers and pharmacies are qualified to prescribe and dispense medications, and to ensure that patients understand the risks and provide informed consent, were insufficient for mifepristone.
In sum, by excluding relevant data and failing to provide “an evidence-based justification for maintaining the mifepristone REMS,” Judge Ballou held FDA’s decision to be arbitrary and capricious. Based on this determination, Judge Ballou further found that FDA violated the Equal Protection Clause by “subjecting mifepristone prescribers, providers, and patients to stricter requirements than those imposed for comparable drugs.”
What Comes Next
Even though he found FDA’s actions to be unlawful, Judge Ballou did not invalidate the 2023 REMS. Instead, he remanded the 2023 REMS back to FDA for further review consistent with the court’s findings. This outcome has largely the same effect as the aforementioned Hawaii decision, meaning that FDA now has two federal courts ordering it to revisit the 2023 REMS by considering all relevant data, and arriving at a well-justified conclusion. As the FDA is undergoing its own “safety review” of mifepristone, the agency will have to contend with the conclusions reached by these two court orders.
This is especially important as State of Louisiana et al. v. FDA et al. proceeds on appeal. There, Louisiana’s attorney general wants the court to require FDA to reinstate the in-person dispensing requirement and eliminate pharmacy access. These restrictions, if FDA were to reimpose them, would apply nationwide, including in states where abortion remains lawful. This past April, a Louisiana district court judge granted the Trump administration’s request to pause that litigation while FDA completed its own “review,” and ordered FDA to provide a status update by October 7, 2026. Louisiana, arguing urgency to resolve this issue, appealed the ruling, and the Fifth Circuit will hear oral arguments on September 9, 2026. A decision could come any time after.
Importantly, patients and providers can still access mifepristone through telehealth while the Louisiana litigation proceeds. With the potential for major changes to mifepristone’s prescribing restrictions on the horizon, the Whole Women’s Health Alliance decision will require FDA to grapple with data showing that even existing restrictions are too burdensome and should help ensure that FDA makes fully justified, evidence-based decisions in regulating mifepristone.
