H.R. 2547

Surrogate Endpoint Improvement and Utilization Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the sponsor of a drug that is eligible for accelerated approval to request that the Food and Drug Administration (FDA) agree to an accelerated approval development plan that includes a surrogate endpoint for the study of the drug and a magnitude of drug effect that is sufficient to claim the drug is effective. (Accelerated approval is an FDA process for approving a new drug for a serious medical condition at a point in the study of the drug that is reasonably likely to predict a clinical benefit instead of at a later point when a clinical benefit can be confirmed.)

The FDA may require the sponsor to modify or terminate an agreed upon plan if additional information indicates that the plan is no longer sufficient to demonstrate the safety and effectiveness of the drug or the drug is no longer eligible for accelerated approval.