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.

中文翻译：

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揭示“性别差异的事实”：政策、监管、女性健康和生物学之间的安必恩剂量。

美国食品和药物管理局 (FDA) 2013 年决定降低女性安必恩推荐剂量，这一决定被广泛引用，作为生物医学中性别差异重要性的标志性例子。本文利用监管文件、科学出版物和媒体报道，分析了这一极具影响力和流动性的“性别差异事实”的形成过程。正如我们所表明的，FDA 的决定是药物审批过程的偶然结果。本文探讨了有争议的性别差异事实如何成为精英女性健康倡导的基础，挖掘了监管程序、倡导团体和媒体在产生科学共识的看法方面的作用，同时排除了正在进行的辩论，最终实现了二元论的稳定。 、生物性别差异事实以及该事实与其构建条件的距离。