Food And Drug Administration v. Alliance For Hippocratic Medicine

Facts

D ensures that drugs on the market are safe and effective. For D to approve a new drug, the drug sponsor (usually the drug’s manufacturer or potential marketer) must submit an application demonstrating that the drug is safe and effective when used as directed. If D determines that additional safety requirements are necessary, D may impose extra requirements on the prescription and use of the drug. In 2000, D approved a new drug application for mifepristone tablets marketed under the brand name Mifeprex. Mifeprex is used to terminate pregnancies, but only up to seven weeks of pregnancy. D placed restrictions on the drug’s use and distribution. Only doctors could prescribe or supervise the prescription of Mifeprex. Doctors and patients also had to follow a strict regimen requiring the patient to appear for three in-person visits with the doctor. D directed prescribing doctors to report incidents of hospitalizations, blood transfusions, or other serious adverse events to the drug sponsor who reported them to D. In 2016, D deemed Mifeprex safe to terminate pregnancies up to 10 weeks rather than 7 weeks. D allowed healthcare providers such as nurse practitioners to prescribe Mifeprex. D approved a dosing regimen that reduced the number of required in-person visits from three to one-a single visit to receive Mifeprex. D changed prescribers’ adverse event reporting obligations to require prescribers to report only fatalities-a reporting requirement that was still more stringent than the requirements for most other drugs. In 2019, D approved an application for generic mifepristone. FDA established the same conditions of use for generic mifepristone as for Mifeprex. In 2021, D relaxed the requirements for Mifeprex and generic mifepristone. Relying on experience gained during the COVID-19 pandemic about pregnant women using mifepristone without an in-person visit to a healthcare provider, D announced that it would no longer enforce the initial in-person visit requirement. This made pro-life advocates upset. They filed petitions with D but D denied them. In 2022. Ps (Four pro-life medical associations, as well as several individual doctors) sued D under the Administrative Procedure Act. They challenged the lawfulness of D’s 2000 approval of Mifeprex; D’s 2019 approval of generic mifepristone; and D’s 2016 and 2021 actions modifying mifepristone’s conditions of use. Ps moved for a preliminary injunction that would require D to rescind approval of mifepristone or, at the very least, to rescind D’s 2016 and 2021 actions. The District Court enjoined D’s approval of mifepristone, thereby ordering mifepristone off the market. The court first held that Ps possessed Article III standing. The court concluded that Ps would suffer irreparable harm from D’s continued approval of mifepristone and that an injunction would serve the public interest. The Fifth Circuit temporarily reinstated D’s approval of Mifeprex but only under the more stringent requirements imposed when D first approved Mifeprex in 2000-available only up to seven weeks of pregnancy, only when prescribed by doctors, and only with three in-person visits, among other requirements. D appealed. The Supreme Court stayed the District Court’s order in its entirety. A few months later, the Court of Appeals issued its decision on the merits of the District Court’s order, affirming in part and vacating in part. It held that Ps had standing and concluded that Ps were not likely to succeed on their challenge to D’s 2000 approval of Mifeprex and 2019 approval of generic mifepristone. The Court of Appeals vacated the District Court’s order as to those agency actions. The Court of Appeals agreed with the District Court that Ps were likely to succeed in showing that FDA’s 2016 and 2021 actions were unlawful. The Supreme Court granted certiorari. 

Issues

Rule of Law

Holding and Decision

Legal Analysis

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