Borchers Andrea T, Hagie Frank, Keen Carl L, Gershwin M Eric
Division of Rheumatology, Allerg and Clinical Immunology, University of California at Davis School of Medicine, Davis, California 95616, USA.
Clin Ther. 2007 Jan;29(1):1-16. doi: 10.1016/j.clinthera.2007.01.006.
The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world. The FDA thus plays an integral role in the use of pharmaceuticals, not only in the United States but worldwide.
The goal of this review was to present an overview of the FDA and place its current role in the perspectives of history and contemporary needs.
Relevant materials for this review were identified through a search of the English-language literature indexed on MEDLINE (through 2006) using the main search terms United States Food and Drug Administration, FDA, history of the FDA, drug approvals, drug legislation, and FDA legislation. Results from the initial searches were then explored further.
The statute that created the bureau which later became the FDA established this agency to prohibit interstate commerce of adulterated foods, drinks, and drugs. The Food, Drug, and Cosmetic Act that replaced it in 1938, and subsequent food and drug laws and amendments, expanded the FDA's responsibilities to cosmetics, medical devices, biological products, and radiation-emitting products. These amendments have also established the FDA as a mainly preventive regulatory agency that relies chiefly on pre-market control. As such, the FDA has played an important role in shaping the modern pharmaceutical industry by making the scientific approach and the clinical trial process the standard for establishing safety and efficacy and by making rigorous scientific analysis the predominant component of the process for pharmaceutical regulation.
As shown in this review, the evolution of the FDA can be described as a series of "crisis-legislation-adaptation" cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA. However, the crises the FDA faces currently are likely to be overcome only under strong and permanent leadership willing to redefine the role and procedures of the FDA with an open mind.
2006年是如今被称为美国食品药品监督管理局（FDA）的监管机构成立100周年。FDA是联邦政府首个消费者保护机构，也可以说是世界上最具影响力的监管机构。因此，FDA不仅在美国，而且在全球范围内的药品使用中都发挥着不可或缺的作用。
本综述的目的是概述FDA，并从历史和当代需求的角度阐述其当前的作用。
通过使用主要搜索词“美国食品药品监督管理局”“FDA”“FDA的历史”“药物批准”“药品立法”和“FDA立法”，在MEDLINE（截至2006年）索引的英文文献中进行检索，确定了本综述的相关材料。然后对初步检索结果进行了进一步探究。
创建后来成为FDA的该局的法规设立该机构的目的是禁止掺假食品、饮料和药品的州际贸易。1938年取代该法规的《食品、药品和化妆品法案》以及随后的食品和药品法律及修正案，将FDA的职责扩大到化妆品、医疗器械、生物制品和辐射发射产品。这些修正案还将FDA确立为一个主要依靠上市前控制的预防性监管机构。因此，FDA通过将科学方法和临床试验过程作为确立安全性和有效性的标准，并使严格的科学分析成为药品监管过程的主要组成部分，在塑造现代制药行业方面发挥了重要作用。
如本综述所示，FDA的演变可以描述为一系列“危机-立法-适应”周期：公共卫生危机推动了国会立法的通过，随后由FDA实施该法律。然而，FDA目前面临的危机可能只有在愿意以开放心态重新定义FDA的作用和程序的强有力和持久的领导下才能克服。
