FDA v. Alliance for Hippocratic Medicine

FDA v. Alliance for Hippocratic MedicineIn 2000, the Food and Drug Administration approved a new drug application for mifepristone tablets marketed under the brand name Mifeprex for use in terminating pregnancies up to seven weeks. To help ensure that Mifeprex would be used safely and effectively, FDA placed additional restrictions on the drug’s use and distribution, for example requiring doctors to prescribe or to supervise prescription of Mifeprex, and requiring patients to have three in-person visits with the doctor to receive the drug. In 2016, FDA relaxed some of these restrictions: deeming Mifeprex safe to terminate pregnancies up to 10 weeks; allowing healthcare providers, such as nurse practitioners, to prescribe Mifeprex; and approving a dosing regimen that required just one in-person visit to receive the drug. In 2019, FDA approved an application for generic mifepristone. In 2021, FDA 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 FDA either to rescind approval of mifepristone or to rescind FDA’s 2016 and 2021 regulatory actions. Danco Laboratories, which sponsors Mifeprex, intervened to defend FDA’s actions. The District Court agreed with the plaintiffs and in effect enjoined FDA’s approval of mifepristone, thereby ordering mifepristone off the market. FDA and Danco appealed and moved to stay the District Court’s order pending appeal. As relevant here, this Court ultimately  stayed the District Court’s order pending the disposition of proceedings in the Fifth Circuit and this Court. On the merits, the Fifth Circuit held that plaintiffs had standing. It 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. This Court granted certiorari with respect to the 2016 and 2021 FDA actions. Held: Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone. Pp. 5–25. Read by Jeff Barnum.