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The First 10 Years: Reflecting on Opportunities and Challenges of the Tobacco Products Scientific Advisory Committee of the United States Food and Drug Administration
Journal of Legal Medicine ( IF 0.703 ) Pub Date : 2021-04-02 , DOI: 10.1080/01947648.2020.1868938
Pebbles Fagan , Thomas Eissenberg , Dina M. Jones , Joanna E. Cohen , Patricia Nez Henderson , Mark S. Clanton

Abstract

Introduction: Tobacco control policies have helped to reduce the health, social, and economic burden of commercial tobacco use worldwide. Little is known about the long-term impact of regulatory policies and functioning bodies that make recommendations to inform policies. The Tobacco Products Scientific Advisory Committee (TPSAC) of the U.S. Food and Drug Administration (FDA) was formed in 2009 to evaluate the safety, health, and dependence of tobacco products and provide related advice and recommendations to the FDA and the Secretary of Health and Human Services. This article describes the first 10 years of the TPSAC activities and reflects on the impact of their service on regulatory actions.

Methods: We reviewed public documents from the 2010–2019 TPSAC meetings to examine the purposes, TPSAC decisions, public health participation in meetings, and concordance of the TPSAC recommendations with regulatory actions. Meeting agendas, transcripts, public testimony, and presentations were reviewed to obtain this information.

Results: Since 2010, the TPSAC held 25 public meetings with 178 speakers who provided oral public testimony. Sixty-four percent of meetings were held from 2010 to 2012, when three congressionally mandated reports were due on the topics of menthol cigarettes, harmful and potentially harmful constituents in tobacco products, and dissolvable tobacco products. Forty-four percent of meetings focused on menthol cigarettes, 32% on modified risk tobacco products, 16% on harmful and potentially harmful constituents, 12% on dissolvable tobacco, and 4% on tobacco addiction/dependence. FDA regulatory actions were largely nonconcordant with voting decisions by TPSAC.

Conclusions: The TPSAC has evaluated an enormous amount of science during the first 10 years, but their influence on regulatory policies has been limited. The TPSAC roles and functioning should be reevaluated to determine how TPSAC can better fulfill its mandate to inform the FDA’s regulatory decision making, which could ultimately reduce the burden of tobacco use in the United States.



中文翻译:

第一个 10 年:反思美国食品和药物管理局烟草制品科学咨询委员会的机遇和挑战

摘要

简介:烟草控制政策有助于减轻全球商业烟草使用的健康、社会和经济负担。人们对监管政策和提出建议以告知政策的职能机构的长期影响知之甚少。美国食品药品监督管理局(FDA)烟草制品科学咨询委员会(TPSAC)成立于2009年,旨在评估烟草制品的安全性、健康性和依赖性,并向FDA和卫生部长提供相关意见和建议。人工服务。本文介绍了 TPSAC 活动的前 10 年,并反映了他们的服务对监管行动的影响。

方法:我们审查了 2010-2019 年 TPSAC 会议的公开文件,以检查目的、TPSAC 决定、公共卫生参与会议以及 TPSAC 建议与监管行动的一致性。审查会议议程、成绩单、公开证词和演示文稿以获取此信息。

结果:自 2010 年以来,TPSAC 举行了 25 次公开会议,有 178 位发言人提供了口头公开证词。64% 的会议是在 2010 年至 2012 年举行的,届时将提交三份国会授权的报告,主题是薄荷醇卷烟、烟草制品中的有害和潜在有害成分以及可溶解的烟草制品。44% 的会议关注薄荷醇卷烟,32% 关注改良风险烟草产品,16% 关注有害和潜在有害成分,12% 关注可溶解烟草,4% 关注烟草成瘾/依赖。FDA 监管行动在很大程度上与 TPSAC 的投票决定不一致。

结论: TPSAC 在前 10 年评估了大量科学,但它们对监管政策的影响有限。应重新评估 TPSAC 的角色和职能,以确定 TPSAC 如何更好地履行其职责,为 FDA 的监管决策提供信息,最终减轻美国的烟草使用负担。

更新日期:2021-04-02
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