Following the Supreme Court's decision in Dobbs, the Biden Administration directed federal agencies to expand access to medication abortion. In response, the FDA updated its Risk Evaluation and Mitigation Strategies (REMS) for mifepristone in 2023, removing the requirement for in-person doctor visits and allowing the drug to be prescribed online and dispensed by mail. Louisiana challenged this regulation under the Administrative Procedure Act, arguing the FDA relied on flawed data and that the rule facilitated illegal abortions and increased state Medicaid costs. The district court found Louisiana likely to succeed and suffering irreparable harm but declined to stay the rule, citing the FDA's ongoing review and the financial interests of drug manufacturers. Louisiana appealed to the Fifth Circuit seeking a stay pending appeal under 5 U.S.C. § 705.
Circuit Judge Duncan, writing for the panel, first addressed threshold arguments regarding standing and exhaustion. The court rejected the FDA's and intervenors' claims that Louisiana lacked standing, holding that the regulation caused sovereign injury by undermining Louisiana's ability to enforce its ban on abortion-inducing drugs and caused financial injury through Medicaid expenditures for emergency care. The court also found Louisiana was not required to exhaust administrative remedies because the FDA had already denied citizen petitions on the issue. On the merits of the stay, the court applied the four-factor test under 5 U.S.C. § 705. The court found Louisiana strongly likely to succeed on the merits because the FDA had eliminated adverse event reporting requirements and then relied on the absence of that data to justify the rule, a flaw the court had previously identified in related litigation. Regarding irreparable harm, the court agreed that the loss of sovereign prerogative to protect unborn life and the irremediable financial costs to the state constituted irreparable harm. Finally, in balancing the equities and public interest, the court held that neither the FDA's interest in completing a future review nor the manufacturers' financial interests outweighed the harm of enforcing a regulation the agency admitted was marred by procedural deficits. The court noted that the public interest is disserved by a drug whose safety the agency has not adequately studied.
The 2023 REMS allowing remote dispensing of mifepristone is temporarily suspended pending the outcome of the underlying Administrative Procedure Act challenge. The FDA's ongoing review of mifepristone protocols may continue, but the specific regulation permitting mail-order dispensing is stayed. This preserves the status quo where in-person dispensing requirements likely remain in effect for Louisiana until the district court resolves the merits of the challenge. The decision leaves open the question of whether the FDA can eventually justify remote dispensing with adequate data.
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