Revisiting Accelerated Approval: A Provocative Rebate Proposal

Formal MACPAC proposal to US Congress to consider enhanced rebates for drugs approved via the Accelerated Approval pathway could have a long shelf life in the context of debates over drug pricing – and over FDA regulatory reforms.

stopwatch and bills
Will faster development mean bigger Medicaid discounts for pharma? • Source: Shutterstock

A new recommendation to Congress from a commission responsible for controlling costs in the US Medicaid program is a very small idea in the context of the broader drug pricing debate – but one that could have larger implications for drug development by prompting a closer look at the Accelerated Approval pathway.

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