Comment from National Center for Health Research

Summary: The National Center for Health Research (NCHR), a nonprofit think tank, opposes the proposed guidance because it allows for the approval of individualized therapies based on insufficient evidentiary standards, such as small nonrandomized studies and surrogate endpoints. They argue that the framework lacks clear criteria for patient population size, fails to ensure robust post-market evidence, and risks creating "financial toxicity" by approving expensive, unproven treatments.