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March 29, 2024

Justices Focus on Article III Standing During Oral Argument in FDA v. Alliance for Hippocratic—the “Abortion Pill” Case

On March 26, 2024, the U.S. Supreme Court heard oral argument in FDA v. Alliance for Hippocratic Medicine. Respondents, doctors and medical associations opposed to abortion, brought suit in the Northern District of Texas challenging the FDA’s approval of mifepristone for termination of early pregnancy in 2000. They also challenged three related FDA actions: (1) amendment of the risk evaluation and mitigation strategies (REMS) in 2016, (2) approval of a generic form of the drug in 2019, and (3) a non-enforcement decision to allow access to the drug by mail in 2021. The district court stayed all four actions. 

On appeal, the Fifth Circuit vacated the stay as to the approvals in 2000 (mifepristone) and 2019 (the generic form) but maintained the district court’s stay as to the 2016 amendment and 2021 decision to permit access by mail. 

Three issues are before the Supreme Court: (1) whether respondents have Article III standing to challenge the FDA’s 2016 and 2021 actions, (2) whether those actions were arbitrary and capricious, and (3) whether the district court properly granted preliminary relief by staying the actions. 

During oral argument, the justices focused heavily on Article III standing. Several justices asked about the type of injury required for organizational and associational standing, and whether any doctor had been harmed by the FDA actions. Justices Barrett and Kagan asked about conscience objection protections, with Justice Kagan asking respondents to identify one respondent whose declaration best shows why they meet Article III standing requirements. Justice Thomas asked Petitioners to identify who would have standing if the Court agreed with them that the Respondents lack it. A decision is expected this summer.   

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