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US FDA Accelerated Approval Council Proposed: Codifying A Failure?

Executive Summary

There is certainly some logic to directing the US FDA to create a council of top managers to assure that the Accelerated Approval pathway is used consistently. But it sure sounds like exactly what the agency did with Aduhelm.

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Medicare has clearly won the battle when it comes to prevent the Alzheimer’s therapy Aduhelm from consuming billions in taxpayer spending based on data that the payor agency finds unconvincing. But in finalizing a policy that has broad implications for all FDA approved therapies, it may be starting a war that it cannot win.

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