Healthcare policy & drug approvals
The Accelerated Shortcut: Inside the FDA's Alzheimer's Gamble
11 min
Internal documents reveal how regulators overruled their own statisticians to approve a failed Alzheimer's drug, exposing how the 'accelerated approval' pathway has become a controversial industry standard.
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Show notes
Internal FDA memos regarding the June 2021 approval of aducanumab.
Statistical review from the FDA Office of Biostatistics (Sylvia Collins).
House Oversight Committee report on the FDA-Biogen 'collaborative workstream'.
Summary of the Food and Drug Omnibus Reform Act (FDORA) of 2022.
Medicare's National Coverage Determination (NCD) for amyloid-targeting monoclonal antibodies.
In this episode
- 1Intro1 min
- 2The Resurrection of Aduhelm2 min
- 3The Surrogate Endpoint Gamble3 min
- 4A Pathway Transformed2 min
- 5The Fallout and Reform2 min
- 6Outro1 min
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