Boston University, Boston, MA, USA.
Am J Law Med. 2022 Dec;48(4):307-342. doi: 10.1017/amj.2023.1.
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.
行政国家所拥有的权力在很大程度上依赖于公众的信任和对循证机构决策的看法。组织声誉是维护监管权力的关键。然而,最近的调查显示,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 在内的许多不同实体的职业科学家都观察到了未报告的政治干预事件。虽然行政部门施加政治影响来设定政策目标和确定机构优先事项可能是有益的,但政治压力绝不能破坏公众对科学机构的信任。最近,公众对 FDA 对 COVID-19 疫情的反应的看法威胁到削弱该机构作为审查黄金标准的长期声誉。COVID-19 大流行暴露了各机构之间以及 FDA 特有的脆弱性。FDA 作为一个日益以公共卫生为重点的机构的演变,必须在政治化科学的环境中运作,这使该机构更容易受到政治干预的风险。毕竟,FDA 参与公共卫生需要增加对非理想、基于价值的决策的参与。纵观其历史,FDA 通过对丑闻的坚决回应,成功地维护了其声誉。COVID-19 大流行提供了一个平台,让 FDA 再次进行内省,并制定保护措施,解决困扰该机构大流行应对的脆弱性问题。本文考察了 FDA 在 COVID-19 早期的应对措施,提出了促进有意义的透明度、公众问责制和科学诚信的改革建议。