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1 results

  • Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform

  • Matthew Herder
  • Journal:
    Journal of Law, Medicine & Ethics / Volume 51 / Issue 4 / Winter 2023
    Published online by Cambridge University Press:
    13 March 2024, pp. 900-919
    Print publication:
    Winter 2023
    • Article
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  • 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.