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首页> 外文期刊>Food and Drug Law Journal >Credible Deterrence: FDA and the Park Doctrine in the 21st Century
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Credible Deterrence: FDA and the Park Doctrine in the 21st Century

机译：可信的威慑力：FDA和21世纪的Park学说

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摘要

The U.S. Food and Drug Administration ("FDA") has a complex regulatory and public health mission that has, over its stormy century-long history, earned it praise and scorn in ample measure. As one recent chronicler of the agency has put it, FDA has long been "venerated in one corner and bemoaned in another" and "targeted for expansion by one voice, for evisceration by a second. On one point, however, those who follow, rely upon, or work with FDA are unanimous: the agency has indisputable reach and significance. FDA wields exceptional power over a wide range of industries whose combined regulated products account for twenty-five cents out of every dollar spent by consumers in this country The agency's arsenal of enforcement tools contains a wide variety of administrative, judicial and other means of punishing companies and individuals who run afoul of the Federal Food, Drug, and Cosmetic Act ("FDCA") or other FDA-enforced statutes. Among the most potent of the tools available to the agency is criminal prosecution, particularly and controversially the power to impose misdemeanor criminal liability for FDCA violations on responsible corporate officers who are neither aware of any wrongdoing nor guilty of any conscious fraud.
机译：美国食品药品监督管理局（“ FDA”）承担着复杂的监管和公共卫生使命，在其漫长的百年风雨历程中，赢得了广泛的赞誉和嘲笑。正如该机构最近的一位编年史家所说，FDA长期以来一直“受人尊敬，而在另一个角落感到“惜”，“目标是用一种声音扩大，用另一种声音去内脏。但是，在某些情况下， FDA依赖或与FDA合作是无可争辩的：该机构具有无可争议的影响力和重要性FDA在广泛的行业中发挥着非凡的力量，这些行业的合规产品占该国消费者每花费1美元的25美分执法工具库包含各种行政，司法和其他手段，用以惩罚违反《联邦食品，药物和化妆品法》（FDCA）或其他FDA强制性法规的公司和个人。该机构可使用的工具是刑事诉讼，尤其是在有争议的情况下，对于不知情的负责任的公司高管，对于违反FDCA的行为施加轻罪的刑事责任如果有任何不当行为或对任何有意识的欺诈行为有罪。

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