Deshmukh Anjali D
GEORGIA STATE UNIVERSITY, ATLANTA, GA, USA.
J Law Med Ethics. 2023;51(4):920-925. doi: 10.1017/jme.2024.4. Epub 2024 Mar 13.
In "Missing the Forest for the Trees: Aduhelm, Accelerated Approvals & the Agency," Dr. Matthew Herder argues that agency capture and politicized discretion drive delays in confirmatory trials of accelerated approval drugs amongst other concerns at US Food and Drug Administration (FDA). In highlighting this important problem and offering nuanced insight into agency workings based in part on interviews with twenty-three unnamed FDA officials and a three-drug case study, Dr. Herder suggests two innovative solutions. However, amidst broader debates balancing agency expertise, data, and delegation, these proposed policy solutions would benefit from more corroborative evidence and consideration of institutional advantages within constitutional limits.
在《只见树木不见森林：阿杜卡努单抗、加速批准与监管机构》一文中，马修·赫德博士认为，在美国食品药品监督管理局（FDA），机构俘获和政治化自由裁量权导致了加速批准药物的确证性试验延迟，这只是诸多问题中的一部分。赫德博士强调了这一重要问题，并通过对23名未具名的FDA官员进行访谈以及一项三药案例研究，对监管机构的运作提供了细致入微的见解，他还提出了两种创新解决方案。然而，在围绕监管机构专业知识、数据和授权进行的更广泛辩论中，这些提议的政策解决方案若能有更多确证性证据，并在宪法限制范围内考虑制度优势，将会更有益处。
