Health Law Daily Wrap Up, PRESCRIPTION DRUGS—W.D. Va.: FDA 2023 REMS modifications for mifepristone were arbitrary and capricious, (Jul 27, 2026)

By Justin Marcus Smith, J.D.

Among many other things, the court noted the stark contrast between the regulation of mifepristone for medication abortion and its less-restricted use for treating Cushing’s syndrome for longer duration at higher doses.

The Food and Drug Administration (FDA) acted arbitrarily and capriciously when it imposed the 2023 Risk Evaluation and Mitigation Strategies (REMS) for prescription and use of the abortion drug mifepristone, held the federal district court in Roanoke, Virginia. The FDA failed to identify specific facts or to offer a reasoned explanation to support its conclusion that REMS modifications removing the in-person dispensing requirement, maintaining the prescriber certification and patient agreement Elements to Assure Safe Use (ETASUs), and adding a new pharmacy certification ETASU, ensured that mifepristone’s benefits outweigh its risks or reduced the burdens on the healthcare system. The 2023 REMS modification was unlawful and also violated the constitutional right to equal protection under the Due Process Clause of the Fifth Amendment. The court remanded to the FDA for review (Whole Woman’s Health Alliance v. FDA, No. 3:23-cv-00019-RSB-JCH (W.D. Va. Jul 23, 2026)).

Background. In May 2023, abortion providers in Virginia, Kansas, and Montana sued the FDA to challenge the 2023 REMS for mifepristone. The 2023 REMS require that (1) prescribing pharmacies be specially certified; (2) prescribing clinicians be specially certified; and (3) prescribers and patients sign a form acknowledging the treatment and its risks.

The abortion providers challenged the FDA 2023 REMS decision as violating the APA by exceeding the agency’s statutory authority, being arbitrary and capricious, and violating the constitutional right to equal protection. They sought declaratory and injunctive relief arguing that the 2023 REMS unduly burdened patient access to mifepristone and that scientific evidence did not support it. The abortion providers also brought an equal protection claim under the Due Process Clause of the Fifth Amendment, contending the FDA treats everyone associated with the prescription and use of mifepristone worse than it does everyone else.

At length, the parties filed cross-motions for summary judgment. The abortion providers sought partial summary judgment on their APA claims that the 2023 REMS exceeded FDA statutory authority and were arbitrary and capricious. The FDA moved the court to award summary judgment on all claims.

The issue before the court was whether the FDA fulfilled its duty under the Administrative Procedure Act, 5 U.S.C. § 706(2)(A)-(C), to conduct a sufficiently thorough review of mifepristone when it imposed the 2023 REMS for prescription and use of the drug. The typical summary judgment standard under Fed. R. Civ. P. 56(c) did not apply to a challenge of final agency action under the APA. Instead, the court reviewed whether the administrative record supported agency action or was otherwise consistent with the APA standard of review as a matter of law. The court applied rational basis review to the equal protection claims in the agency context.

Regulatory capsule. The court described the regulatory history of mifepristone at great length.

In short, in January 2023, the FDA issued a final REMS decision in line with the modifications announced in December 2021. The FDA provided most of its rationale for the 2023 REMS modifications in the 2021 REMS modification rationale, but it supplemented that explanation in the 2023 joint summary rationale. The 2023 joint summary rationale provided the FDA response to the sponsors’ modification proposals and small changes to the REMS announced in the 2021 REMS modification rationale.

The FDA’s stated goal was to mitigate the risk of serious complications associated with mifepristone. To that end, the 2023 REMS included three ETASUs. The FDA retained the prescriber certification and the patient agreement form ETASUs; removed the in-person dispensing requirement; and added a new pharmacy certification ETASU that limited mifepristone distribution to pharmacies specially certified under the REMS program to ensure mifepristone would only be dispensed pursuant to prescriptions written by certified prescribers.

Standing. The FDA contended the abortion providers lacked Article III standing, but the court found the abortion providers were subject to the 2023 REMS and alleged that the REMS directly injured them by causing delays in their certification of new hires and creating administrative burdens. The court ruled the abortion providers had standing.

Remedy exhaustion. The FDA argued the abortion providers failed to exhaust administrative remedies because they did not file a citizen petition, but the court found the abortion providers established futility. The court said it was clear the FDA would have denied the abortion providers’ claim in light of many other medical community challenges to the mifepristone REMS over time. The court said the FDA could not plausibly claim that a new citizen petition would change its position that the REMS remained necessary for terminating pregnancy despite the proven safety of mifepristone.

Statutory authority. Turning to the APA merits, the court denied summary judgment on the abortion providers’ first claim, that the FDA exceeded its statutory authority in issuing the 2023 REMS. The court granted summary judgment to the FDA as to this issue. The abortion providers had only challenged how the FDA exercised its valid authority, not whether it had authority to issue, review, or modify the REMS under the statute.

Arbitrary decision. Next, the court agreed with the abortion providers on their second claim, that the 2023 REMS modification rationale was arbitrary and capricious as a matter of law. This was so because (1) the FDA failed to provide a satisfactory explanation for its decision and (2) excluded relevant data.

The court agreed with the abortion providers that an FDA REMS modification decision must consider whether changes are necessary to (1) ensure drug benefits outweigh risks in light of the six initial approval factors at 21 U.S.C. § 355-1(a); and (2) to address the burdens the REMS impose on the healthcare system, including, in the case of an ETASU, the factors at § 355-1(f).

The court found the FDA provided an insufficient justification and excluded several key categories of data, including statements from leading medical societies and data on provider and patient burdens. Even considering that the FDA asserted it did not have to consider the initial approval or ETASU factors and could therefore ignore publications examining data relevant to those factors, the objective safety limitation excluded data the FDA acknowledged it was required to consider. For example, the FDA excluded references that analyzed clinician perspectives on access to mifepristone, data about pregnancy risks, and incidence of adverse events among pregnant people who did not use the drug, but the FDA was required to consider minimization of the burden on the health care delivery system. Exclusion of data directly related to a statutorily mandated factor made the FDA decision arbitrary and capricious. Moreover, the FDA did not justify the exclusion, nor did it address its disagreement with the leading medical associations.

ETASUs. Turning to the ETASUs, the court said the FDA mischaracterized and misapplied the relevant statutory burden it must meet to impose a REMS. A REMS modification may only include an ETASU if the FDA would otherwise withdraw approval for the drug due to a “serious specific risk” without the ETASU. The court said the FDA, rather than satisfying its burden to confirm that the REMS were necessary for drug benefits to outweigh risks, instead “subtly” shifted the burden to those challenging the REMS to show they were no longer necessary. The court found the FDA declined to consider literature that supported removal of the ETASUs and did not explain why it would withdraw approval for the mifepristone REMS without each ETASU.

The court also identified other problems with the FDA analysis, including: consideration of factors outside statutory mandate; placing access burdens where it was not clear they made the drug safer; and failure to justify the REMS wholistically. The FDA went into detail as to each ETASU, but even so, failed to address multiple medical association conclusions that mifepristone is safe without a REMS.

Prescriber certification. Turning next to each ETASU, the court also found several problems with the FDA’s reasoning as to the prescriber certification ETASU and detection of ectopic pregnancies and heavy bleeding. The court said a standard clinical license should be enough to assure a provider meets qualifications. An exceptional prescriber certification was unnecessarily duplicative. Conditioning the continuation of an ETASU on more study as to whether clinicians defy their professional duties was irrational. A Canadian study showed patient outcomes after removal of REMS-like restrictions in Canada.

The FDA also failed to address statutorily required factors in determining that the prescriber certification ETASU should be retained. The FDA did not show that mifepristone risks are so high that it would withdraw approval without the prescriber certification ETASU. The FDA made a conclusory statement that the provider certification REMS component was necessary, but that was insufficient to justify an ETASU.

Patient consent. The FDA did not tie the patient agreement or consent ETASU requirement to health outcomes. According to the court, the FDA concluded it could not determine whether the consent form was necessary, yet declined to remove it. Again, the FDA did not apply the required concept that the risks were so high that it would withdraw approval without this ETASU. The FDA also characterized ETASUs as permissible if not unreasonably burdensome on providers or patients, but this directly contravened the statutorily mandated factor at § 355-1(f)(1)(A).

More broadly, FDA reasoning for the patient agreement was thin and lacked supporting evidence for how it offered protections beyond those already provided by standard medical counseling. The FDA failed to explain why the patient agreement ETASU was not redundant or why it was necessary to achieve REMS objectives. Without a reasoned analysis, the FDA decision could not stand.

Pharmacy certification. The pharmacy certification REMS was also arbitrary and capricious. The FDA stated it might burden the healthcare system and patient access, but concluded it would advance the 2023 REMS goal of ensuring pharmacies comply with REMS requirements and dispense mifepristone only by prescription from certified prescribers. However, the FDA provided no evidence as to why this was necessary. An increase in prescribers and a reduction of safety after elimination of the in-person dispensing requirement was only speculative.

Equal protection. Insofar as the court concluded that the FDA acted arbitrarily and capriciously in issuing the 2023 REMS modification, the court also found the record lacked any rational basis for subjecting mifepristone prescribers, providers, and patients to stricter requirements than those imposed for comparable drugs. The court accordingly denied the FDA’s motion for summary judgment on the abortion providers’ constitutional claims.

The case is No. 3:23-cv-00019-RSB-JCH.

Judge: Ballou, R.

Attorneys: Gail Marie Deady (Center For Reproductive Rights) for Whole Woman's Health Alliance. Noah T. Katzen, U.S. Department of Justice, for United States Food and Drug Administration.

Companies: Whole Woman's Health Alliance

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