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The will of Congress? Permissive regulation and the strategic use of labeling for the anti-influenza drug Relenza

机译:国会的意志?抗流感药物Relenza的宽松法规和标签的战略用途

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摘要

Through an analysis of the FDA's approval of the controversial anti-influenza drug Relenza (zanamivir), we interrogate distinct social scientific theories of pharmaceutical regulation. We investigate why, despite internal negative opinions and an Advisory Committee's non-approval recommendation, the FDA approved Relenza in the late 1990s. Based on a close reading of FDA documents, we show how agency officials guided the manufacturer's analyses and participated in constructing a tenuous argument for approval. We show how regulators may strategically design drug labels that can justify their permissive regulation. We consider the explanatory power of official accounts and alternative, partially overlapping, theories of pharmaceutical regulation in the Relenza case, and develop new insights into the institutional dynamics of regulator-industry relations. We find little or no evidence that the FDA was primarily driven by public health concerns, pressure from disease-based patient activism, or a consumerist and neoliberal regulatory logic, although some of these explanations provided managers with convenient rhetoric to rationalize their actions. Rather, we argue that the Relenza case highlights contradictions between a scientific culture at FDA, conducive to rigorous product evaluations, and the agency's attempts to accommodate higher-level political (i.e. Congress) and industry demands conducive of permissive regulation - consistent with some aspects of reputational and capture theories, as well as with corporate bias theory.
机译:通过分析FDA对有争议的抗流感药物Relenza(zanamivir)的批准,我们研究了不同的药物监管社会科学理论。我们调查了为何尽管有内部负面意见和咨询委员会的不批准建议,但FDA在1990年代后期批准了Relenza。在仔细阅读FDA文件的基础上,我们展示了代理商官员如何指导制造商的分析并如何参与构建一个脆弱的论证以获得批准。我们将展示监管机构如何策略性地设计可以证明其宽松监管合理的药物标签。我们考虑了在Relenza案中官方账户和替代性,部分重叠的药品监管理论的解释力,并对监管机构与行业关系的制度动力发展出新见解。我们几乎没有发现或没有证据表明FDA主要是由公共卫生问题,基于疾病的患者行动主义所带来的压力,或者是消费者主义和新自由主义的监管逻辑所驱动,尽管其中一些解释为管理人员提供了方便的措辞,使他们的行为合理化。相反,我们认为Relenza案凸显了FDA的科学文化,有利于严格的产品评估,以及该机构为适应更高级别的政治(即国会)和行业要求而做出的,有利于宽松监管的尝试之间的矛盾-与声誉和捕获理论,以及公司偏见理论。

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