Pharmacogenetic tests provide genetic data to tailor drug treatment and were widely predicted to be one of the first fruits of the Human Genome Project. In the mid-2000s, the US Food and Drugs Administration (FDA) became an advocate for pharmacogenetic testing, but its efforts to build a market for this new technology brought the agency into dispute with other regulatory actors over the type of evidence needed for the adoption of pharmacogenetic testing, in particular the importance of randomized control trials. The warfarin case highlights the tension between a new form of promissory regulation driven by future expectations and FDA's established role as protector of public health; and the controversy can be conceptualized as a struggle over regulatory epistemologies within a complex polycentric regulatory space. Our case study addresses two themes central to the burgeoning scholarship on the governance of emergent science and technologies (EST): the political economy of regulation, in particular the role that regulators play in creating markets for EST; and the epistemological politics of regulatory science, in particular the controversy that arises when regulators modify scientific standards to accommodate EST. Linking these two themes is the concept of promissory regulation: the idea that regulatory policy may be shaped by an institutional commitment to the transformational potential of EST. This concept sheds new light on the neo-mercantilist nature of contemporary regulatory capitalism.

中文翻译：

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视觉与数据的比例：通过授权监管促进新兴科学和技术、FDA 和个性化医疗的案例

药物遗传学测试提供基因数据来定制药物治疗，并被广泛预测为人类基因组计划的首批成果之一。在 2000 年代中期，美国食品和药物管理局 (FDA) 成为药物遗传学检测的倡导者，但其为这项新技术建立市场的努力使该机构与其他监管机构就检测所需证据的类型产生了争议。 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .采用药物遗传学检测，尤其是随机对照试验的重要性。华法林案凸显了由未来期望驱动的新形式的承诺监管与 FDA 作为公共健康保护者的既定角色之间的紧张关系；这场争论可以被概念化为在复杂的多中心监管空间内对监管认识论的斗争。监管的政治经济学，特别是监管者在为 EST 创造市场方面所发挥的作用；以及监管科学的认识论政治，特别是当监管者修改科学标准以适应 EST 时出现的争议。将这两个主题联系起来的是承诺监管的概念：监管政策可能会受到对 EST 转型潜力的制度承诺的影响。这一概念为当代监管资本主义的新重商主义性质提供了新的启示。