Article ID: CBB457938987

Making a ‘sex-difference fact’: Ambien dosing at the interface of policy, regulation, women’s health, and biology (2023)

unapi

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.

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Authors & Contributors
Carpenter, Daniel
Tobbell, Dominique Avril
Abraham, John
Brushwood, David B.
Campbell, Nancy D.
Carstairs, Catherine
Journals
Pharmacy in History
Social History of Medicine
Bulletin of the History of Medicine
Chemical Heritage
Social Studies of Science
Publishers
MIT Press
Duke University Press
Pharmaceutical Products Press
Princeton University Press
University of California Press
University of Chicago Press
Concepts
Pharmacy
Legislative and administrative regulations
Narcotics and drugs
Pharmaceutical industry
Medicine and politics
Therapeutic practice; therapy; treatment
People
Fahlberg, Constantin
Higby, Gregory J.
Remsen, Ira
Time Periods
20th century
21st century
20th century, late
19th century
20th century, early
Places
United States
Great Britain
Massachusetts (U.S.)
New Mexico (U.S.)
Canada
South Africa
Institutions
United States. Food and Drug Administration (USFDA)
American Medical Association
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