2023/05/06 by Helen Zhao, Helen Hailin Zhao, Marina DiMarco +7 · 1 voice
Medicine · #Science, Research, and Medicine #Sex and Gender in Healthcare
paper · pdf · doi:10.1177/03063127231168371
openalex publication_date 2023/05/06 · openalex created_date 2025/10/10 · openalex updated_date 2026/08/01
The U.S. Food and Drug Administration's (FDA) 2013 decision to lower recommended Ambien dosing for women has been widely cited as a hallmark example of the importance of sex differences in biomedicine. Using regulatory documents, scientific publications, and media coverage, this article analyzes the making of this highly influential and mobile 'sex-difference fact'. As we show, the FDA's decision was a contingent outcome of the drug approval process. Attending to how a contested sex-difference fact came to anchor elite women's health advocacy, this article excavates the role of regulatory processes, advocacy groups, and the media in producing perceptions of scientific agreement while foreclosing ongoing debate, ultimately enabling the stabilization of a binary, biological sex-difference fact and the distancing of this fact from its conditions of construction.