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Accelerated Approval – Taking the FDA’s Concerns Seriously

Document Type

Article

Publication Date

2022

Publication Title

New England Journal of Medicine

Abstract

As the U.S. Congress debates a must-pass bill reauthorizing Food and Drug Administration (FDA) user fees for drug and device companies, the future of the FDA’s accelerated-approval program has become a focus of policy discussion. This debate was amplified in part by the agency’s controversial approval in June 2021 of the Alzheimer’s disease drug aducanumab (Aduhelm), whose high price and unclear benefits highlighted key challenges associated with the accelerated-approval process and reignited criticisms of the program. In both formal legislative-proposal requests and appearances before Congress, FDA officials have asked for greater authority to require companies to conduct more timely confirmatory trials of drugs that are granted accelerated approval and to expedite the agency’s process for withdrawing drugs when such trials don’t show evidence of clinical benefit. Although earlier congressional proposals would have addressed both these issues, legislators settled on compromise proposals that do not.

Keywords

Food And Drug Administration, Medicaid, Accelerated Approval, Drug Pricing

Publication Citation

Rachel E. Sachs, Julie M. Donohue & Stacie B. Dusetzina, Accelerated Approval — Taking the FDA’s Concerns Seriously, 387 New England Journal of Medicine 199 (2022)

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