Re-Framing Biotechnology Regulation.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2017-01-01
Alison Peck
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引用次数: 0

Abstract

Biotechnology is about to spill the banks of federal regulation. New genetic engineering techniques like CRISPR-Cas9 promise revolutionary breakthroughs in medicine, agriculture, and public health—but those techniques would not be regulated under the terms of the Coordinated Framework for Regulation of Biotechnology. This revolutionary moment in biotechnology offers an opportunity to correct the flaws in the framework, which was hastily patched together at the advent of the technology. The framework has never captured all relevant technologies, has never satisfied the public that risk is being effectively managed, and has never been accessible to small companies and publicly-funded labs that increasingly are positioned to make radical, life-saving innovations. This Article offers a proposal for new legislation that would reshape biotechnology regulation to better meet these goals. Key reforms include tying regulation to risk rather than technology category; consolidating agency review; capturing distinct regulatory expertise through inter-agency consultations; creating a clearinghouse to help guide applicants and disseminate information; setting up more comprehensive monitoring of environmental effects; and providing federal leadership to fill key data gaps and address socio-economic impacts.

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重新构建生物技术法规。
生物技术即将溢出联邦监管的银行。CRISPR-Cas9等新的基因工程技术有望在医学、农业和公共卫生领域取得革命性突破,但这些技术不会受到《生物技术监管协调框架》的监管。生物技术的这一革命性时刻提供了一个机会来纠正框架中的缺陷,这些缺陷是在技术出现时匆忙拼凑起来的。该框架从未涵盖所有相关技术,从未让公众满意风险正在得到有效管理,也从未让越来越多的小公司和公共资助的实验室能够使用,而这些公司和实验室正越来越多地准备进行激进的、挽救生命的创新。本文提出了一项新的立法建议,该建议将重塑生物技术监管,以更好地实现这些目标。关键改革包括将监管与风险而非技术类别挂钩;加强机构审查;通过机构间磋商获取独特的监管专业知识;建立信息交流中心,帮助指导申请人和传播信息;建立更全面的环境影响监测;为填补关键数据缺口和解决社会经济影响提供联邦领导。
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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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