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严格管控:一个世纪的药品监管

Keeping the lid on: a century of drug regulation and control.

作者信息

Spillane Joseph, McAllister William B

机构信息

Department of History, Center for Studies in Criminology and Law, University of Florida, PO Box 115950, Gainesville, FL 32611-5950, USA.

出版信息

Drug Alcohol Depend. 2003 Jun 5;70(3 Suppl):S5-12. doi: 10.1016/s0376-8716(03)00096-6.

Abstract

Since the early 1900s, national and international drug control legislation has acted as a key site of contention between important societal actors. Physicians and pharmacists, regulators and drug companies, patients and addicts, and researchers and pharmacologists all attempted to influence formulation and interpretation of the rules that regulate access to addicting but medically useful substances. The 1970 Controlled Substances Act (CSA) consolidated and rationalized previous US domestic legislation and paid careful attention to the international aspects of the issue. Yet the CSA also incorporated long-standing fundamental disputes about who would act as gatekeepers, what criteria would be employed in regulatory decisions, and the basic goals of drug control legislation. Rather than view the CSA as a beginning or an end, it is better conceived as a major milepost in a century-long odyssey of maneuvering among interested parties for advantage in a complex regulatory environment. Instead of providing a definitive authoritative structure to which all parties must adhere, the CSA has served as a vehicle for discernment and continuous renegotiation of essential concepts such as "abuse liability".

摘要

自20世纪初以来,国家和国际药物管制立法一直是重要社会行为体之间争论的关键焦点。医生和药剂师、监管机构和制药公司、患者和瘾君子,以及研究人员和药理学家都试图影响有关获取成瘾但具有医学用途物质的规则的制定和解释。1970年的《受控物质法》(CSA)整合并合理化了美国先前的国内立法,并仔细关注了该问题的国际方面。然而,CSA也纳入了长期存在的根本性争议,即谁将担任把关人、监管决策中将采用哪些标准以及药物管制立法的基本目标。与其将CSA视为一个起点或终点,不如将其更好地理解为在长达一个世纪的历程中,利益相关方在复杂监管环境中为谋取优势而进行周旋的一个重要里程碑。CSA并没有提供一个所有各方都必须遵守的明确权威架构,而是成为了一个用于辨别和持续重新谈判诸如“滥用可能性”等基本概念的工具。

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