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Accelerated approval provides a process for hastening access to innovative interventions for patients with serious or life-threatening diseases for which no other options are available. However, accelerated approval has been, at times, controversial due to uncertainties related to whether pharmaceuticals approved under the accelerated approval pathway, which relies on surrogate endpoints rather than a direct measure of clinical benefit, have met the same standards for safety and efficacy as drugs approved under the Federal Drug Administration (FDA) traditional approval pathway and whether the pathway has been used for products for which it was not intended. On January 30-31, 2023, an ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine Committee on Science, Technology, and Law hosted a virtual workshop to examine the FDA accelerated approval program, one of several pathways designed to facilitate and expedite the development and review of new pharmaceuticals. This publication summarizes the presentations and discussion of the workshop.
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