Letter on S.3133/H.R.5497, The Conditional Approval Act

The signatories oppose the proposed Conditional Approval Act, arguing it duplicates the FDA’s existing accelerated approval pathway and risks replicating its shortcomings, including reliance on weak surrogate endpoints and delayed postapproval evidence. Instead, they recommend strengthening accelerated approval with stricter confirmatory trial requirements and improving the expanded access pathway to preserve rigorous preapproval evidence generation while maintaining patient access.