Supreme Court Holds that Plaintiffs Lack Standing to Challenge FDA Actions Regarding Regulation of Mifepristone

June 18, 2024

On June 13, 2024, the Supreme Court of the United States held in Food and Drug Administration v. Alliance for Hippocratic Medicine that a consortium of doctors and medical organizations opposed to abortion did not have legal standing to challenge the FDA’s actions regarding mifepristone.

Mifepristone is an oral abortifacient available to patients in both brand name form (Mifeprex), which the FDA approved in 2000, and generic form, which the FDA approved in 2019. In 2016, the FDA relaxed its original restrictions on access to the drug, which included a minimum requirement of three in-person consultations between patients and doctors, by allowing other healthcare providers, such as nurse practitioners, to prescribe the drug and reducing the in-person consultation requirements to a single visit. The FDA then announced in 2021 that it would no longer enforce the in-person consultation requirement, a determination that was made in the context of the then-ongoing COVID-19 pandemic but one that the agency left in place after the pandemic subsided.

Just a few months after the United States Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization to overturn Roe v. Wade, the doctor plaintiffs moved the US District Court for the Northern District of Texas to issue a preliminary injunction requiring the FDA to either rescind its approval of mifepristone altogether or, in the alternative, to rescind its 2016 and 2021 regulatory actions. In response, Danco Laboratories, which sponsors Mifeprex, intervened to defend the FDA’s actions.

The District Court agreed with the plaintiffs and enjoined the FDA’s approval of mifepristone, effectively ordering the drug off the market. FDA and Danco appealed and moved to stay the District Court’s order pending appeal. The Supreme Court ultimately stayed the District Court’s order pending the disposition of proceedings in the Fifth Circuit.

On the merits, the Fifth Circuit held that the plaintiffs had legal standing to sue and concluded that plaintiffs were unlikely to succeed on their challenge to FDA’s 2000 and 2019 drug approvals but were likely to succeed in showing that FDA’s 2016 and 2021 actions were unlawful. The FDA and Danco then asked the Supreme Court to review that ruling.

The Supreme Court reversed the Fifth Circuit’s decision, holding that the plaintiffs lacked standing under Article III of the Constitution to bring suit. Article III limits the jurisdiction of federal courts to actual disputes between parties – which it calls “Cases” or “Controversies” – and so a plaintiff filing suit in federal court must establish “standing” to be heard by demonstrating that that he or she has suffered or likely will suffer an injury in fact, that the injury likely was caused or will be caused by the defendant being sued, and that the injury likely would be redressed by the requested judicial relief.

Writing for a unanimous Court, Justice Kavanaugh acknowledged the plaintiffs’ “sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone,” but because they themselves neither use nor want to prescribe mifepristone nor are they forced to prescribe mifepristone or are otherwise obliged to participate in providing abortion-related medical treatment over their conscientious objections to abortion, they did not have standing to challenge the FDA’s treatment of mifepristone in federal court.

The Court observed that the plaintiffs lacked standing because they failed to demonstrate that the FDA’s treatment of mifepristone had injured them or could potentially injure them in any way. Rather, the plaintiffs objected only to what the FDA’s actions allowed other people to do, and in the Court’s view, “a plaintiff’s desire to make a drug less available for others does not establish standing to sue.”

This case has been heavily covered by news outlets and other media because of its subject matter and importance, especially in the aftermath of the Dobbs decision, and many reports have framed the Court’s decision in this case as a victory for supporters of greater access to mifepristone and reproductive options in general.

While this is certainly true as a practical matter, it is important to note that this is not because the Supreme Court made a ruling in support of those policies. Nor, it should be said, did it make a ruling in opposition to those policies. Rather, the Court held only that because the plaintiff doctors lacked standing to challenge the FDA’s policies in federal court, no “Case” existed in which a federal court could make a ruling at all.

As such, while plan sponsors and other stakeholders can operate with the understanding that the FDA’s rules that have made mifepristone widely available remain in effect, they should not assume that this case marks the final word on the subject. Plan sponsors and other stakeholders should continue to monitor ongoing political developments in the executive and legislative branches of the federal government as well as any future legal developments in the judicial branch in the event another plaintiff can establish the necessary standing to challenge these rules that the doctors in this case ultimately could not.

Food and Drug Administration v. Alliance for Hippocratic Medicine