US Food and Drug Administration, Accelerated Approvals, Drug Regulation, Alzheimer’s Disease
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.
Matthew Herder, "Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform" (2024) JL Medicine & Ethics [forthcoming in 2024].