美国诉卡罗尼亚:商业言论自由的力量日益增强,并可能重新强调将标签外促销分类为“虚假和误导”。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2013-01-01
Marc J Scheineson, Guillermo Cuevas
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引用次数: 0

摘要

美国食品和药物管理局(FDA)禁止标签外促销药品的权力在美国诉卡罗尼亚案中再次遭受严重挫折。考虑到医生在行医过程中可以合法地为未经批准的用途开出处方药的法律制度,联邦上诉法院确认了制造商对合法销售的产品使用真实、无误导性言论的商业言论自由权。由于这个案例,以及其他决定的基础,FDA可能会更谨慎地质疑制造商的宣传,只有当它能证明声称是不真实的,而是虚假的或误导的,或者以其他方式剥夺处方者充分的使用说明。
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United States v. Caronia: The increasing strength of commercial free speech and potential new emphasis on classifying off-label promotion as "false and misleading".

The authority of the United States Food and Drug Administration (FDA) to prohibit off-label promotion of drug products suffered another serious setback in United States v. Caronia. Viewing a legal system where physicians can prescribe prescription pharmaceuticals for unapproved uses legally in their practice of medicine, the Federal appeals court affirmed the commercial free speech rights of manufacturers to use truthful, non-misleading speech about lawfully marketed products. As a result of this case, and others upon which the decision is based, FDA is likely to challenge manufacturer promotion more carefully, and only if it can demonstrate that claims are not truthful, but are false or misleading, or otherwise deprive the prescriber of adequate directions for use.

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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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