On the recordMay 24, 2012
Section 901 of the managers' amendment to S. 3187, Enhancement of Accelerated Patient Access to New Medical Treatments states that an accelerated approval under section 506(b) of the Federal Food, Drug, and Cosmetic Act is subject to certain limitations, including the requirement that the sponsor conduct appropriate post- approval studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit. Does the lack of an explicit reference to postapproval validation of surrogate endpoints, as described in current law, in any way restrict the Secretary's existing authority to require such validation postapproval?
