ICER, in collaboration with Verdant Research, published a new white paper that examines the evolution – and perception – of the FDA accelerated approval pathway.
The paper, titled “Strengthening the FDA’s Accelerated Approval Pathway: Progress and Unfinished Business,” reviews recent regulatory and market changes and proposes several policy options that focus on improvements that could be made by regulators, payers, and manufacturers.
Date of publication: April 2026
For more information, please contact [email protected].
“The goal of the accelerated approval pathway has always been to ensure that patients receive innovative treatments faster. We can point to several successes where patients have benefited from expedited access to transformative medications. However, there are also many instances of regulatory inconsistency, lagged development of confirmatory trial data, and access restrictions that have limited patient use. Patients, manufacturers, payers, and purchasers are frustrated. The policy options laid out in this paper are designed to build on the successes of the accelerated approval pathway and address the challenges that remain, in service to affordable access for patients.”
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