Greenwood Kate
Center for Health & Pharmaceutical Law & Policy, Seton Hall University School of Law, USA.
Am J Law Med. 2011;37(2-3):278-98. doi: 10.1177/009885881103700204.
Critics of the Food & Drug Administration's ban on off-label promotion often claim that it violates the First Amendment because it suppresses pharmaceutical manufacturers' truthful speech about their legal--and beneficial--products. Characterizing the ban on off-label promotion in this way has more than rhetorical significance. Bans on truthful, non-misleading speech elicit special skepticism because of the belief that they "usually rest solely on the offensive assumption that the public will respond 'irrationally' to the truth." The legislative history of the provisions of the Food Drug and Cosmetic Act that underlie the ban on off-label promotion, however, reveals that Congress was concerned that physicians were responding rationally to false and misleading promotional claims. In this Article, I explore the doctrinal questions raised by conceiving of the ban on off-label promotion not as a ban on "truthful speech to physicians" but instead as a prophylaxis against false and misleading pharmaceutical promotion. I review the evidence that false and misleading claims were commonplace before the ban's adoption and persist today, along with the enforcement challenges the FDA confronted at that time and would confront were the ban lifted, and conclude the government likely could develop the factual record necessary to establish that Congress' rejection of an after-the-fact case-by-case approach to combating false and misleading prescription drug promotion is constitutional.
食品药品监督管理局（FDA）禁止药品标签外推广的批评者常常声称，这一禁令违反了美国宪法第一修正案，因为它压制了制药商关于其合法且有益产品的真实言论。如此描述禁止标签外推广的禁令，其意义远不止于修辞层面。对真实且非误导性言论的禁令引发了特别的质疑，因为人们认为此类禁令“通常仅仅基于一种冒犯性的假设，即公众会对真相做出‘非理性’反应”。然而，构成禁止标签外推广禁令基础的《食品、药品和化妆品法案》条款的立法史表明，国会担心医生会对虚假和误导性的促销声明做出理性反应。在本文中，我探讨了将禁止标签外推广的禁令，并非视为对“向医生的真实言论”的禁令，而是视为对虚假和误导性药品推广的预防措施所引发的理论问题。我回顾了相关证据，即在禁令实施之前，虚假和误导性声明屡见不鲜且至今依然存在，以及FDA当时所面临的执法挑战，若禁令解除它将面临的挑战，并得出结论：政府很可能能够建立起必要的事实记录，以证明国会拒绝采用事后逐案处理方式来打击虚假和误导性处方药推广是符合宪法的。
