FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2016-08-01
Frank J Sasinowski, Alexander J Varond
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引用次数: 0

Abstract

This article examines the strength of scientific and clinical evidence for FDA's nineteen non-AIDS, non-cancer Subpart H approval determinations over the Accelerated Approval program's twenty-four year existence. The authors researched the bases for FDA's determinations when an unvalidated surrogate or intermediate clinical endpoint is "reasonably likely to predict clinical benefit." The four key factors set forth in FDA's "Guidance for Industry, Expedited Programs for Serious Conditions - Drugs and Biologics" were applied to past Subpart H approvals. For the nineteen precedents, the authors found wide variances between the quantum and quality of evidence on each of the four factors, indicating that a lack of evidence on any single factor was not disqualifying in and of itself. The results of this study, therefore, show that FDA exercises extraordinarily more regulatory flexibility than either FDA's foundational statutes or even FDA' s most recent 2014 Expedited Programs Guidance explicitly express. Given recent legislative exhortations and the increasing promise of personalized medicine and translational sciences, the authors conclude that Subpart H should be further explored and utilized. The authors provide a detailed analysis of the orecedents established in the nineteen approvals.

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FDA在子部分H批准中的灵活性:评估有效性证据的数量。
本文考察了FDA加速审批项目24年来19项非艾滋病、非癌症批准的科学和临床证据的强度。作者研究了FDA确定未经验证的替代药物或中间临床终点“合理可能预测临床获益”的依据。FDA“行业指南,严重疾病加速计划-药物和生物制品”中规定的四个关键因素适用于过去的H部分批准。对于19个先例,作者发现四个因素中每一个的证据数量和质量存在很大差异,这表明缺乏任何一个因素的证据本身并不会取消资格。因此,这项研究的结果表明,与FDA的基础法规甚至FDA最近的2014年快速项目指南明确表达的相比,FDA行使了更大的监管灵活性。鉴于最近的立法劝告和个性化医疗和转化科学的日益增加的承诺,作者得出结论,子部分H应进一步探索和利用。作者对19个批准中建立的先例进行了详细的分析。
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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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