Does Sackett foreshadow the end of non-reviewability for FDA warning letters?

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2013-01-01
Katelyn DeRuyter
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引用次数: 0

Abstract

FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedure Act (APA). The Supreme Court's analysis in Sackett v. EPA suggests the legal tides might be shifting. In Sackett, the Court held that an Environmental Protection Agency (EPA) compliance order was considered final agency action subject to judicial review under the APA. While there are differences between compliance orders and warning letters, both inform regulated parties of non-compliance with federal law and are highly valued measures of inducing "voluntary compliance." Sackett should provide precedent for future litigation over judicial reviewability of warning letters.

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Sackett是否预示着FDA警告信不可复审的终结?
FDA警告信被认为是非最终机构行为,因此不受行政程序法(APA)下的司法审查。最高法院在Sackett诉EPA案中的分析表明,法律潮流可能正在转变。在Sackett案中,法院认为环境保护署(EPA)的合规命令被认为是根据《行政程序法》接受司法审查的最终机构行动。虽然合规令和警告信之间存在差异,但两者都通知受监管方不遵守联邦法律,并且是诱导“自愿遵守”的高度重视措施。Sackett应该为未来关于警告信的司法可复审性的诉讼提供先例。
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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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