Sen. Wyden Using Califf Nomination To Extract Accelerated Approval Reforms
The unexpectedly tight fight to get Robert Califf confirmed as FDA commissioner is giving lawmakers additional leverage to extract commitments. However, the Senate Finance Chair may be overestimating FDA’s ability to swiftly pull accelerated approvals without new legislation.
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The US FDA's comment came in response to a question about whether accelerated approval encourages sponsors to conduct lower-quality studies to enter the market.
Indicating that failure should be expected may be a subtle reminder of the potential consequences of placing more guardrails on the expedited approval pathway.
If approved, Oregon would be the first state granted the authority to exclude coverage of accelerated approval drugs, even if manufacturers provide the statutory rebates required for Medicaid.