Scheineson Marc J, Cuevas Guillermo
Food Drug Law J. 2013;68(2):201-16, iii.
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.
在美国诉卡罗尼亚案中，美国食品药品监督管理局（FDA）禁止药品标签外推广的权力再次遭受严重挫折。鉴于在这样一个法律体系中，医生在行医过程中可以合法地为未经批准的用途开具处方药，联邦上诉法院确认了制造商就合法上市产品使用真实、非误导性言论的商业言论自由权。由于此案以及作为该判决依据的其他案件，FDA可能会更加谨慎地挑战制造商的推广行为，并且只有在能够证明相关声明不真实、虚假或具有误导性，或者以其他方式剥夺开处方者足够的使用说明时才会这样做。
