FDA领域的合成生物学:走向生产监督评估。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2015-01-01
Leili Fatehi, Ralph F Hall
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引用次数: 0

摘要

合成生物学(SB)有望在广泛的领域创造巨大的机会,包括受美国食品和药物管理局监管的食品、治疗和诊断。与此同时,对于准确评估此类SB产品的人类健康和环境风险的不确定性,我们有充分的理由感到关切。因此,人工智能是一系列新兴技术中最新的一项,人们呼吁采取新的监管和监督方法,包括“超前思考”,预测技术发展上游的治理挑战,并采用既能适应风险新信息,又能对绩效数据和政策结果反馈做出反应的监督机制。这些新办法明显地背离了现状,它们的发展和实施将需要相当多的时间、资源和责任的重新分配。此外,为了制定适当的监督响应,适应性或非适应性,首先需要确定可能构成监督挑战的应用程序的具体类型和性质、不确定性和监管问题。本文提出了我们对生产性监督评估(POA)方法的看法,其中评估监督系统的能力和缺陷的目的是使监督的生产性决策(即,及时、可行、有效地实现预期的政策结果)成为可能,同时也建立能力以促进更广泛的治理工作。poa的值是2倍。第一,它将促进发展一种可推广的办法,以便对任何新技术的监督作出生产性规划和决策,因为任何新技术对其政策目标涉及的任何监督系统构成挑战和不确定性。其次,这一努力可以通过奠定基础和提供有价值的数据来支持未来关于新兴技术治理的规范性审议,从而加强在预期和适应性方法下所倡导的过程。
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Synthetic Biology in the FDA Realm: Toward Productive Oversight Assessment.

Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United States Food and Drug Administration. At the same time, there is substantial basis for concern about the uncertainties of accurately assessing the human health and environmental risks of such SB products. As such, SB is the latest in a string of emerging technologies that is the subject of calls for new approaches to regulation and oversight that involve "thinking ahead" to anticipate governance challenges upstream of technological development and adopting oversight mechanisms that are both adaptive to new information about risks and reflexive to performance data and feedback on policy outcomes over time. These new approaches constitute a marked departure from the status quo, and their development and implementation will require considerable time, resources, and reallocation of responsibilities. Furthermore, in order to develop an appropriate oversight response, adaptive or otherwise, there is first a need to identify the specific types and natures of applications, uncertainties, and regulatory issues that are likely to pose oversight challenges. This article presents our vision for a Productive Oversight Assessment (POA) approach in which the abilities and deficits of an oversight system are evaluated with the aim of enabling productive decisions (i.e., timely, feasible, effective for achieving desired policy outcomes) about oversight while also building capacity to facilitate broader governance efforts. The value ofPOA is two-fold. First, it will advance the development of a generalizable approach for making productive planning and decision-making about the oversight of any given new technology that presents challenges and uncertainties for any given oversight system whose policy goals are implicated by that technology. Second, this effort can enhance the very processes advocated under anticipatory and adaptive approaches by laying the groundwork for and providing valuable data to support future normative deliberations about the governance of emerging technologies.

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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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