On June 13, 2024, the Supreme Court of the United States (SCOTUS) unanimously held in FDA v. Alliance for Hippocratic Medicine that plaintiff physicians and pro-life medical associations lacked Article III standing to challenge the U.S. Food and Drug Administration’s (FDA) regulation of mifepristone, a prescription drug primarily used in terminating pregnancy. Following the ruling, mifepristone remains available and approved. Also importantly, SCOTUS reasoned that a desire to make a drug less available for others does not establish standing to sue FDA. Since SCOTUS focused on standing as a threshold issue, the broader question of whether the FDA acted within its authority and jurisdiction to approve mifepristone remains unanswered.
Author
Jack Yang
BrowsingJack Yang is a Summer Associate in Bake McKenzie, Washington DC office.