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1917年《与敌贸易法》与合成药物:缓解短缺、控制价格并建立上市前许可控制。

The Trading with the Enemy Act of 1917 and synthetic drugs: relieving scarcity, controlling prices, and establishing pre-market licensing controls.

作者信息

Cooper Dale

出版信息

Pharm Hist. 2005;47(2):47-61.

PMID:16447341
Abstract

The "Trading with the Enemy Act" (TWEA) was enacted in October 1917 after America's entry into World War I and during a period of wartime scarcity and rising prices of synthetic drugs and dyestuffs that began in 1914. It was described as "An Act to define, regulate, and punish trading with the enemy, and for other purposes." The act and subsequent executive orders authorized an "Alien Property Custodian" to take control of all enemy property within the United States. Also, The Federal Trade Commission (FTC) was authorized to issue licenses for the use of enemy owned patents, which covered a range of industrial and consumer products. Significantly, the FTC was given the power to set the conditions for use of the patents and to fix the price for those products necessary for health. The effect of these measures was to bring federal pre-marketing control over the production, testing, and pricing of the most therapeutically significant synthetic drugs of the day. Enactment of the TWEA and the events preceding and surrounding it are significant parts of the history of the American pharmaceutical industry and federal regulation.

摘要

《与敌贸易法》(TWEA)于1917年10月在美国参加第一次世界大战后、在1914年开始的战时合成药物和染料短缺及价格上涨期间颁布。该法被描述为“一项界定、规范和惩罚与敌贸易并用于其他目的的法案”。该法案及随后的行政命令授权一名“敌产保管人”控制美国境内的所有敌产。此外,联邦贸易委员会(FTC)被授权为使用敌国拥有的专利发放许可,这些专利涵盖一系列工业和消费品。重要的是,联邦贸易委员会有权设定专利使用条件,并为健康所需产品定价。这些措施的效果是使联邦政府对当时最具治疗意义的合成药物的生产、测试和定价进行上市前控制。《与敌贸易法》的颁布以及此前和周围发生的事件是美国制药行业和联邦监管历史的重要组成部分。

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