On the recordMay 24, 2012
To receive accelerated approval, the managers' amendment requires that FDA determine that a surrogate or clinical endpoint is reasonably likely to be predictive of an effect on clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality as of the time of granting accelerated approval and the standards under section 505(c) of the FDCA or section 351(a) of the Public Health Service Act are met. In meeting such a requirement, it is appropriate for the Secretary to seek data and information to show that the surrogate or clinical endpoint is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. I would just like to reiterate that nothing in these amendments to section 506(b) is intended to alter the FDA's historical practice of utilizing unvalidated surrogates to grant accelerated approval in appropriate cases or its practice of granting traditional approval under section 505(b) based on validated surrogates in appropriate cases.
