Food and Drug Administration v. Alliance for Hippocratic Medicine

Facts of the Case

Provided by Oyez

Medication abortion in the U.S. is commonly conducted using a combination of mifepristone and misoprostol. Mifepristone was approved by the U.S. Food and Drug Administration (FDA) in September 2000 and is used in over half of all U.S. abortions. Initially, its distribution was limited to hospitals and medical facilities under FDA regulations. The 2007 Food and Drug Administration Amendments Act introduced Risk Evaluation and Mitigation Strategies (REMS), reinforcing FDA's control over drug approvals. Despite REMS review in 2011, mifepristone's distribution remained restricted. In March 2016, the FDA expanded access, allowing medical practitioners to prescribe it and extending the usage period in pregnancy. In April 2021, due to the COVID-19 pandemic, the FDA permitted mail distribution from certified sources, and in January 2023, approved pharmacies also began distributing it.

However, following the Supreme Court's June 2022 decision in Dobbs v. Jackson Women's Health Organization, which eliminated the constitutional right to abortion, several states sought to restrict mifepristone’s sale. The Alliance for Hippocratic Medicine and other anti-abortion groups challenged the FDA’s approval, claiming inadequate consideration of evidence in 2000. In April 2023, a federal district court judge sided with the plaintiffs, suspending the FDA’s approval. The U.S. Court of Appeals for the Fifth Circuit partially stayed this decision, maintaining the original 2000 approval but striking down the 2016 REMS changes that eased access. After a hearing on the merits, in August 2023, the Fifth Circuit upheld the ban on changes made in 2016. The U.S. Supreme Court granted review and stayed the lower court’s injunction.

Questions

Do respondents have Article III standing to challenge the Food and Drug Administration’s 2016 and 2021 actions with respect to mifepristone’s approved conditions of use?
Were the FDA’s 2016 and 2021 approvals of mifepristone arbitrary and capricious?
Did the district court properly grant preliminary relief?

Conclusions

Alliance for Hippocratic Medicine and other plaintiffs lack Article III standing to challenge the Food and Drug Administration’s regulatory actions regarding mifepristone. Justice Brett Kavanaugh authored the unanimous opinion of the Court.

The plaintiff doctors and medical associations, none of whom prescribe or use mifepristone, do not allege direct monetary injuries, property injuries, or physical injuries from FDA's actions relaxing the regulation of mifepristone. Rather, they have legal, moral, ideological, and policy concerns about abortion. While these concerns are legitimate, they do not suffice on their own to confer Article III standing to sue in federal court.

Given the broad and comprehensive conscience protections guaranteed by federal law, the plaintiffs have not shown that FDA's actions will cause them to suffer any conscience injury. Additionally, the causal link between FDA’s regulatory actions and the alleged monetary and related injuries (e.g., diverting resources, increased risk of liability suits, potentially increasing insurance costs) is too speculative or attenuated to establish standing. Finally, the medical associations have not demonstrated organizational standing. Thus, even if true that no one would be able to challenge FDA’s actions if the plaintiffs cannot, the Court has long rejected this “if not us, who?" argument as a basis for standing.

Justice Clarence Thomas authored a concurring opinion reiterating that associational (or organizational) standing is simply another form of third-party standing and that the Court should, in another case, explain just how the Constitution permits associational standing.