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引用次数: 0
摘要
美国食品和药物管理局(FDA)决定加速批准阿杜单抗(aducanumab,Aduhelm)这一治疗阿尔茨海默氏症的药物,这一决定引起了争议,并引发了多项政策改革。通过对其他获得加速审批的药物的案例分析以及对食品及药物管理局高级官员的访谈,我认为改革应该是有依据的,但不是由阿杜库单抗决定的。相反,我们需要进行结构性改革,重塑 FDA 的核心优先事项,恢复监管体系对科学严谨性的承诺。
Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform.
The US Food and Drug Administration's controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer's disease, has motivated multiple policy reforms. Drawing a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA's core priorities and restore the regulatory system's commitment to scientific rigor.
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.