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An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation

机译：FDA对图形警告标签法规的成本和收益的分析评估

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摘要

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA's authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules.
机译：2009年的《防止家庭吸烟和烟草控制法》授予食品和药物管理局（FDA）对卷烟和无烟烟草制品的监管权，并授权其对其他烟草制品主张管辖权。与其他联邦机构一样，要求FDA评估其重大监管措施的成本和收益。迄今为止，FDA已经发布了一项经济影响分析，其中一项提议的规则以及一项最终规则要求在卷烟包装上使用图形警告标签（GWL），最近发布的一项提议规则将主张FDA对除卷烟和无烟烟草以外的烟草产品的授权。鉴于FDA在其有关GWL的拟议和最终规则中评估净经济利益的方法存在争议，并且根据合理的经济分析准备经济影响分析的重要性，于是在2014年初，一群著名的经济学家开会审查了该方法并，在指明的地方提供改进分析的建议。我们得出的结论是，对GWL的吸烟影响的分析大大低估了收益，而高估了成本，导致FDA大大低估了GWL的净收益。我们希望FDA将发现我们的评估对随后的分析有用，不仅包括GWL，而且还包括与烟草制品有关的其他法规。我们讨论的大多数内容都适用于评估烟草制品法规的成本和收益的所有情况，并且我们认为，在FDA对拟议规则的未来分析中应考虑到这一点。

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  • 来源
    《Tobacco control》 |2015年第2期|112-119|共8页
  • 作者

    Frank J Chaloupka; Kenneth E Warner; Daron Acemoglu; Jonathan Gruber; Fritz Laux; Wendy Max; Joseph Newhouse; Thomas Schelling; Jody Sindelar;

  • 作者单位

    Department of Economics, Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA;

    Department of Health Management & Policy, University of Michigan, Ann Arbor, Michigan, USA;

    Department of Economics, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA;

    Department of Economics, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA;

    Department of Economics, Northeastern State University, Broken Arrow, Oklahoma, USA;

    Institute for Health & Aging, University of California, San Francisco, California, USA;

    Department of Health Care Policy, Harvard University, Cambridge, Massachusetts, USA;

    Department of Economics, University of Maryland, College Park, Maryland, USA;

    Health Policy and Management, Yale University, New Haven, Connecticut, USA;

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