{"title":"Great Trees Require Strong Roots: Evaluating Data and Delegation Doctrine Underlying Proposed Reforms to FDA's Accelerated Approval Program.","authors":"Anjali D Deshmukh","doi":"10.1017/jme.2024.4","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":1.6000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10937175/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Law Medicine & Ethics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1017/jme.2024.4","RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/3/13 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ETHICS","Score":null,"Total":0}
引用次数: 0
Abstract
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.
大树需要强根:评估美国食品及药物管理局加速审批计划改革提案所依据的数据和授权理论》(Evaluating Data and Delegation Doctrine underlying Proposed Reforms to FDA's Accelerated Approval Program.
在《只见树木,不见森林:马修-赫德博士(Dr. Matthew Herder)认为,美国食品和药物管理局(FDA)在加速审批药物的确证试验方面存在的其他问题包括:机构俘获和政治化的自由裁量权导致了确证试验的延误。赫德博士强调了这一重要问题,并根据对 23 位未透露姓名的 FDA 官员的访谈和对三种药物的案例研究,提出了对机构运作的细致入微的见解。然而,在平衡机构专业知识、数据和授权的广泛辩论中,这些建议的政策解决方案将受益于更多的确凿证据,以及在宪法限制范围内对机构优势的考虑。
期刊介绍:
Material published in The Journal of Law, Medicine & Ethics (JLME) contributes to the educational mission of The American Society of Law, Medicine & Ethics, covering public health, health disparities, patient safety and quality of care, and biomedical science and research. It provides articles on such timely topics as health care quality and access, managed care, pain relief, genetics, child/maternal health, reproductive health, informed consent, assisted dying, ethics committees, HIV/AIDS, and public health. Symposium issues review significant policy developments, health law court decisions, and books.