Supreme Court Unanimously Strikes Down Legal Challenge to Abortion Drug

Yesterday, the Supreme Court issued a decision in Food and Drug Administration v. Alliance for Hippocratic Medicine, No. 23-235, 2024 WL 2964140 (Jun. 13, 2024), finding unanimously that the Plaintiffs, a group of anti-abortion doctors, lacked standing to challenge the FDA’s approval of the abortion pill mifepristone. In 2000, the FDA approved an application for mifepristone tablets, marketed under the brand name Mifeprex. Originally, the FDA implemented several restrictions on the drug’s use and distribution, such as requiring doctors to prescribe or to supervise the prescription of mifepristone. However, the FDA relaxed these restrictions in 2016 and again in 2021, determining that mifepristone was safe to terminate pregnancies up to 10 weeks; allowing healthcare providers, such as nurse practitioners to prescribe the drug; not requiring any initial in-person visit to receive the drug; making telehealth available for medication abortion; and allowing mail-order pharmacies to ship pills to patients.

This case began in 2022 when four pro-life medical associations and several individual doctors sued the FDA in the U.S. District Court for the Northern District of Texas. The litigants challenged the lawfulness of the 2000 approval of Mifeprex; FDA’s 2019 approval of generic mifepristone; and FDA’s 2016 and 2021 actions modifying mifepristone’s conditions of use. The District Court agreed with the plaintiffs and enjoined FDA’s approval of mifepristone. See Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, 668 F.Supp.3d 507, 560 (N.D. Tex. Apr. 7, 2023). The court held that the plaintiffs possessed Article III standing and found that the plaintiffs were likely to succeed on the merits of their claims challenging both the original approval and the FDA’s actions in relaxing restrictions on medication abortion. With this ruling, the Texas court effectively invalidated the FDA’s approval of the pill. However, last April the Supreme Court put that ruling on hold which allowed the pill to remain available while the litigation was pending.

The case then reached the 5th U.S. Circuit Court of Appeals in August. The Fifth Circuit decision vacated the district court’s ruling against approval of the drug in 2000 on the grounds that the claim was barred by the statute of limitations. The decision also vacated the ruling against the 2019 approval for lack of standing because the Plaintiffs failed to present evidence that they were injured. However, the Circuit Court upheld the district court’s order staying the 2016 Amendments, which relaxed initial restrictions, and the 2021 decision, which allowed abortion medication to be dispensed by mail. See Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration, 78 F.4th 210 (5th Cir. Aug. 16, 2023). Both sides appealed to the Supreme Court. The Supreme Court opted against hearing the challenges to the original approval of mifepristone in 2000 and the generic approval in 2019, focusing solely on the later FDA actions which loosened safety and prescription restrictions.

Plaintiffs challenged the FDA's relaxed regulation of mifepristone, asserting Article III standing under the theory that they have suffered or would likely suffer injury caused by the FDA’s actions. Specifically, the Plaintiffs argued that as pro-life, anti-abortion doctors, they had “sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others.” Food and Drug Administration v. Alliance for Hippocratic Medicine, 2024 WL 2964140 at *1. Plaintiffs contended the FDA’s relaxed regulation of mifepristone might cause downstream conscience injuries to individual doctors who might be forced to participate in an abortion or provide “abortion-related medical treatment” against their conscience. See id. at *2.

The Supreme Court rejected the Plaintiffs' standing theory. In order to establish standing, “the plaintiff cannot be a mere bystander, but instead must have a ‘personal stake’ in the dispute.” The Court ruled that the doctors had not suffered a concrete injury in fact. Justice Brett Kavanaugh, writing for the court, noted that “a plaintiff’s desire to make a drug less available for others does not establish standing to sue. Nor do the plaintiffs’ other standing theories suffice.” Id. at *3.

Takeaway

Notably, by hinging the decision upon standing grounds, the court avoided reaching a decision on the legal merits of whether the FDA acted lawfully in lifting various restrictions. Although Justice Kavanaugh’s opinion does suggest other ways that abortion opponents could challenge the FDA’s relaxed abortion restrictions “[t]he plaintiffs may present their concerns and objections to the President and FDA in the regulatory process, or to Congress and the President in the legislative process.” Id. at *14. But for now, the ruling ensures that abortion pills, the abortion method that accounts for more than half of abortion procedures nationwide, will remain widely available in the United States.

As new developments arise, we will continue to update our Dobbs Decision Resource Center.  In the meantime, please contact one of the lawyers in Shipman’s Health Law practice group if you have questions about this ever-changing legal landscape.