The Yin And Yang Of Accelerated Approval Reform Proposals
The challenges to reforming the US FDA Accelerated Approval pathway are nicely illustrated by comparing the first two legislative proposals offered by the Democratic and Republican leadership. The bills are almost exactly opposite in intent – though perhaps there is some room for consensus on first steps.
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Indicating that failure should be expected may be a subtle reminder of the potential consequences of placing more guardrails on the expedited approval pathway.
The bill, some version of which is undoubtedly destined for the FDA user fee package, also would codify existing labeling guidance for products cleared through the pathway.
Ideas to reform Accelerated Approval are likely to be debated during the reauthorization of the key US FDA user fee funding authority in 2022. Here are three suggestions for Congress to consider.