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Shattering the Mirage: The FDA’s Early COVID-19 Pandemic Response Demonstrates a Need for Reform to Restore Agency Credibility
American Journal of Law & Medicine ( IF 0.694 ) Pub Date : 2023-04-11 , DOI: 10.1017/amj.2023.1
Christina Fuleihan 1
Affiliation  

The power afforded to the administrative state is heavily reliant on public trust and the perception of evidence-based agency decision-making. Organizational reputation is key to preserving regulatory power. However, recent investigations reveal that existing scientific integrity policies may not be sufficient to preserve the credibility of many federal agencies. In fact, a significant number of career scientists across various entities – including the FDA – have observed unreported incidents of political interference. While political influence exerted by the executive branch to set policy goals and determine agency priorities can be beneficial, political pressures must not undermine public trust in scientific agencies. Recently, public perception regarding the FDA’s COVID-19 response threatened to weaken the agency’s longstanding reputation as the gold standard of review. The COVID-19 pandemic publicized vulnerabilities that exist across agencies, as well as those that are unique to the FDA. The FDA’s evolution as an increasingly public health-focused agency that must function in the landscape of politicized science exposes the agency to a greater risk of political interference. After all, the FDA’s involvement in public health requires increased participation in non-ideal, value-based decision-making. Throughout its history, the FDA has managed to maintain its reputation through its firm responses to scandal. The COVID-19 pandemic provides a platform for the FDA to – once again – look introspectively and institute safeguards addressing vulnerabilities that plagued the agency’s pandemic response. This Article examines the FDA’s early COVID-19 response to propose reforms that promote meaningful transparency, public accountability, and scientific integrity.

中文翻译:

打破海市蜃楼:FDA 的早期 COVID-19 大流行反应表明需要进行改革以恢复机构的信誉

赋予行政国家的权力在很大程度上取决于公众信任和对基于证据的机构决策的看法。组织声誉是维护监管权力的关键。然而,最近的调查表明,现有的科学诚信政策可能不足以维护许多联邦机构的信誉。事实上,包括 FDA 在内的许多实体的职业科学家都观察到了未报告的政治干预事件。虽然行政部门为制定政策目标和确定机构优先事项施加的政治影响可能是有益的,但政治压力不得破坏公众对科学机构的信任。最近,公众对 FDA 的 COVID-19 反应的看法有可能削弱该机构作为审查黄金标准的长期声誉。COVID-19 大流行公开了跨机构存在的漏洞,以及 FDA 独有的漏洞。FDA 作为一个越来越以公共卫生为重点的机构的演变,必须在政治化的科学领域发挥作用,这使该机构面临更大的政治干预风险。毕竟,FDA 参与公共卫生需要更多地参与非理想的、基于价值的决策。纵观其历史,FDA 一直通过对丑闻的坚定回应来维护其声誉。COVID-19 大流行病为 FDA 提供了一个平台,可以再次反省并制定保障措施,解决困扰该机构大流行病应对措施的漏洞。本文审查了 FDA 对 COVID-19 的早期回应,以提出促进有意义的透明度、公共责任和科学诚信的改革。
更新日期:2023-04-11
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