TY - JOUR
T1 - Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform
AU - Herder, Matthew
N1 - Matthew Herder, "Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform" (2024) JL Medicine & Ethics [forthcoming in 2024].
PY - 2024/1/1
Y1 - 2024/1/1
N2 - 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 upon 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.
AB - 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 upon 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.
KW - US Food and Drug Administration
KW - Accelerated Approvals
KW - Drug Regulation
KW - Alzheimer’s Disease
UR - https://digitalcommons.schulichlaw.dal.ca/scholarly_works/1076
M3 - Article
JO - Articles, Book Chapters, & Popular Press
JF - Articles, Book Chapters, & Popular Press
ER -