Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines

IF 2.3 3区 哲学 Q1 ETHICS Hastings Center Report Pub Date : 2023-11-14 DOI:10.1002/hast.1525
Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, William B. Feldman
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Abstract

The Covid-19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions. Ensuring that the FDA is itself trustworthy is important for justifying public trust in its actions, like vaccine approvals, thereby promoting public health. We propose five conditions of trustworthiness that the FDA should meet when it reviews vaccines, even during emergencies: consistency with rules, proper expert or political decision-makers, proper decision-making and noninterference, connection to public preference, and transparency of both reasons and procedures. The five conditions provide a road map of procedural and substantive requirements, which the FDA has variably implemented, focused on ensuring appropriate influence of political interests. While being a trustworthy agency cannot guarantee the public's trust, implementing these conditions builds a groundwork for public trust.

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确保FDA的可信赖性,建立公众对疫苗的信任
2019冠状病毒病大流行凸显了有必要审查公众对美国食品和药物管理局(FDA)疫苗批准程序的信任,以及政治影响在FDA决策中的作用。确保FDA本身值得信赖,对于证明公众对其行动(如疫苗批准)的信任是重要的,从而促进公众健康。我们提出了FDA在审查疫苗时,即使是在紧急情况下,也应该满足的五个可信赖的条件:与规则的一致性,适当的专家或政治决策者,适当的决策和不干涉,与公众偏好的联系,以及原因和程序的透明度。这五个条件提供了程序性和实质性要求的路线图,FDA以不同的方式实施,重点是确保政治利益的适当影响。作为一个值得信赖的机构,虽然不能保证公众的信任,但这些条件的实施为公众的信任奠定了基础。
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来源期刊
Hastings Center Report
Hastings Center Report 医学-卫生保健
CiteScore
3.50
自引率
3.00%
发文量
99
审稿时长
6-12 weeks
期刊介绍: The Hastings Center Report explores ethical, legal, and social issues in medicine, health care, public health, and the life sciences. Six issues per year offer articles, essays, case studies of bioethical problems, columns on law and policy, caregivers’ stories, peer-reviewed scholarly articles, and book reviews. Authors come from an assortment of professions and academic disciplines and express a range of perspectives and political opinions. The Report’s readership includes physicians, nurses, scholars, administrators, social workers, health lawyers, and others.
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