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The Yin And Yang Of Accelerated Approval Reform Proposals

 
• By Michael McCaughan

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.

yin yang in sand
Accelerated approval reforms won't be a day at the beach, but there do appear some changes that can find wide agreement. • Source: Alamy

The legislative effort to reform the US Food & Drug Administration’s Accelerated Approval process is beginning with a telling demonstration that the fundamental challenge for lawmakers is not a lack of desire to improve the pathway – but a lack of consensus of what “improving” AA actually means.

One group of reformers views AA as permitting manufacturers to make exorbitant profits on unproven treatments, with no consequences for...

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