巴克曼提出:联邦政府优先处理州对食品药品监督管理局的欺诈行为。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2014-01-01
Christine A Gaddis
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引用次数: 0

摘要

许多州颁布了法规,在产品责任诉讼中为药品制造商提供保护。此外,这些州中有几个州制定了“FDA欺诈”的法定条款,如果原告能够提供证据证明药品制造商在获得药品上市批准的过程中向FDA做出虚假陈述,则取消了在产品责任诉讼中给予药品制造商的法定保护。目前,联邦巡回法院在这些州的“fda欺诈”法规是否应该被联邦优先考虑的问题上存在分歧。这个问题需要药品制造商、普通公民和州立法机构来解决。本评论将讨论FDA在药品和医疗器械监管方面的权力的历史和作用;联邦优先购买权和最高法院关于在药品和医疗器械方面,州法律未对索赔提出警告是否属于联邦优先购买权的裁决;最高法院在巴克曼诉原告法律委员会案中作出的判决,法院认为医疗器械制造商向FDA作出欺诈性陈述的索赔应被联邦优先考虑,因为此类索赔干扰了FDA与其监管实体之间的关系,州FDA欺诈法律规定,以及现有的巡回法院关于这些法规是否应被联邦优先考虑的分歧;电路分裂的潜在解决方案;并将得出结论并主张最高法院对巴克曼案的裁决适用于联邦优先处理州对食品药品监督管理局欺诈的法规,因为此类法规涉及联邦机构与其监管实体之间的关系,从而削弱了食品药品监督管理局的权威。
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Buckman extended: federal preemption of state fraud-on-the-FDA statutes.

A number of states have enacted statutes that provide protection to drug manufacturers in product liability actions. Additionally, several of these states have enacted "fraud-on-the-FDA" statutory provisions, which remove statutory protection afforded to drug manufacturers in product liability actions if plaintiffs can provide evidence that the drug manufacturer made misrepresentations to the FDA during the process of obtaining marketing approval for the drug. Currently, the federal circuits are in disagreement over whether these state "fraud-on-the-FDA" statutes should be federally preempted. This issue warrants resolution for drug manufacturers, private citizens, and state legislatures. This Comment will discuss the history and role of the FDA's authority in drug and medical device regulation; federal preemption generally and the Supreme Court's decisions that considered whether state law failure to warn claims are federally preempted in the context of drugs and medical devices; the Supreme Court's decision in Buckman v. Plaintiffs' Legal Committee, where the Court held that claims that a medical device manufacturer made fraudulent representations to the FDA were federally preempted because such claims interfered with the relationship between the FDA and the entities it regulated, state fraud-on-the-FDA statutory provisions, and the existing circuit split regarding whether those statutes should be federally preempted; the potential resolutions to the circuit split; and will conclude and advocate that the Supreme Court's Buckman holding be applied to federally preempt state fraud-on-the-FDA statutes because such statutes involve the relationship between a federal agency and the entity it regulates and thus undermine the FDA's authority.

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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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