URL Pharma, Inc., Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, USA.
Adv Ther. 2011 Oct;28(10):842-56. doi: 10.1007/s12325-011-0059-4. Epub 2011 Sep 1.
Despite more than a century of evolving federal legislation, there remain many unapproved drugs on the United States (US) market. This article reviews the history of drug approval in the US, beginning with the landmark Pure Food and Drug Act of 1906, through to the development of the US Food and Drug Administration (FDA). The Pure Food and Drug Act of 1906 was the first comprehensive federal legislation covering drug regulation. Intervening legislation, such as the Federal Food, Drug, and Cosmetic Act of 1938 and Kefauver-Harris Amendments in 1962, was later instituted. In June 2006, a century after the development of the FDA as an enforcement body, an initiative was undertaken to remove unapproved drugs from the marketplace. The Marketed Unapproved Drugs-Compliance Policy Guide outlines enforcement policies aimed at efficiently and rationally bringing all unapproved and illegally marketed drugs into the approval process, or discontinuing their manufacture, distribution, and sale. The FDA has been actively pursuing control of unapproved drugs in recent years, with an approach concentrating on drug safety to ensure optimal public health and consumer protection.
尽管美国联邦立法已经历经了一个多世纪的发展演变，但仍有许多未经批准的药品在市场上流通。本文回顾了美国药品审批的历史，从 1906 年具有里程碑意义的《纯净食品和药品法案》开始，一直到美国食品和药物管理局（FDA）的发展历程。1906 年的《纯净食品和药品法案》是第一部涵盖药品监管的综合性联邦立法。随后颁布了一些干预性立法，如 1938 年的《联邦食品、药品和化妆品法案》和 1962 年的 Kefauver-Harris 修正案。2006 年 6 月，在 FDA 成立 100 周年之际，一项从市场上清除未经批准药品的倡议被提上日程。《已上市未经批准药品合规政策指南》概述了旨在高效、合理地将所有未经批准和非法销售的药品纳入审批程序，或停止其生产、分销和销售的执法政策。近年来，FDA 一直在积极控制未经批准的药品，其方法侧重于药品安全，以确保公众健康和消费者保护的最优化。
