On the recordMay 24, 2012
The managers' amendment to 3187 revises section 506(b), removing the explicit language in current law requiring postapproval validation of surrogate endpoints. However, this is not intended to restrict the Secretary's current ability to require such validation postapproval, if appropriate. Equally important, the change likewise is not intended to suggest that any such validation should now occur prior to approval under section 506(b). Rather, in keeping with current practice, the bill's new language continues to permit the Secretary to require postapproval studies to verify the effect on the surrogate endpoint or predicted clinical outcome, i.e., verification of the predicted clinical benefit. In addition, it continues to allow the Secretary to withdraw an accelerated approval if the required studies fail to verify and describe the predicted effect.
