Kavanaugh: Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone.

In 2000, the Food and Drug Administration (FDA) approved the use of mifepristone tablets, marketed under the brand name Mifeprex, for terminating pregnancies up to seven weeks. The FDA imposed additional restrictions on the drug's use and distribution, including requiring doctors to prescribe or supervise the prescription of Mifeprex and requiring patients to have three in-person visits with the doctor to receive the drug. In 2016, the FDA relaxed some of these restrictions, and in 2021, it announced that it would no longer enforce the initial in-person visit requirement. Four pro-life medical associations and several individual doctors moved for a preliminary injunction that would require the FDA to either rescind approval of mifepristone or rescind the FDA’s 2016 and 2021 regulatory actions.

The District Court agreed with the plaintiffs and effectively enjoined the FDA's approval of mifepristone, ordering it off the market. The FDA and Danco Laboratories, which sponsors Mifeprex, 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 and the Supreme Court. On the merits, the Fifth Circuit held that plaintiffs had standing 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 Supreme Court granted certiorari with respect to the 2016 and 2021 FDA actions.The Supreme Court of the United States held that the plaintiffs lack Article III standing to challenge the FDA’s actions regarding the regulation of mifepristone. The Court found that the plaintiffs, who are pro-life and oppose elective abortion, have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others. However, because the plaintiffs do not prescribe or use mifepristone, they are unregulated parties who seek to challenge the FDA’s regulation of others. The Court concluded that the plaintiffs' theories of causation were insufficient to establish Article III standing. The Court reversed the judgment of the Fifth Circuit and remanded the case for further proceedings consistent with its opinion.

Kavanaugh Supreme Court Holdign in FDA v. Alliance for Hippocratic Medicine.pdf

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