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
Lois Sheng Liu
BrowsingLois is a member of the Firm's Litigation & Government Enforcement Practice Group in the FDA sub-group, based in Washington, DC. Prior to joining Baker McKenzie, Lois worked as an associate for another multinational law firm.
As a former pharmacist and a research fellow at a major teaching hospital, Lois has an extensive understanding of various regulatory issues related to clinical research and development, marketing strategy, product approval, and government enforcement activities.