Surrogate Endpoint Improvement and Utilization Act of 2015

To amend the Federal Food, Drug, and Cosmetic Act to provide for the development of accelerated approval development plans for investigational drugs and biological products. 1. Short title This Act may be cited as the Surrogate Endpoint Improvement and Utilization Act of 2015 2. Accelerated approval development plan (a) In general Section 506 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 (g) Accelerated approval development plan (1) In general In the case of a drug determined to be eligible for accelerated approval under subsection (c), at any time after the submission of an application for the investigation of the drug under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, the sponsor of such drug may voluntarily request agreement by the Secretary to an accelerated approval development plan with respect to a surrogate endpoint to be used to study the drug. (2) Plan A plan described in paragraph (1) shall include agreement on— (A) the surrogate endpoint to be assessed under the plan; (B) the design of the study that will utilize the surrogate endpoint; and (C) the magnitude of the effect of the drug on the surrogate endpoint that is the subject of the agreement that would be sufficient to form the primary basis of a claim that the drug is effective. (3) Modification; termination The Secretary may require the sponsor of a drug that is the subject of an accelerated approval development plan to modify or terminate the plan if additional data or information indicates that— (A) the plan as originally agreed upon is no longer sufficient to demonstrate the safety and effectiveness of the drug involved; or (B) the drug is no longer eligible for accelerated approval under subsection (c). (4) Sponsor consultation If the Secretary requires the modification or termination of an accelerated approval development plan under paragraph (3), the sponsor shall be granted a request for a meeting to discuss the basis of the Secretary’s decision before the effective date of the modification or termination. (5) Definition In this section, the term accelerated approval development plan (A) is reasonably likely to predict clinical benefit; and (B) is intended to be the basis of the accelerated approval of a drug under subsection (c). . (b) Technical amendments Section 506 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 (1) by striking (f) Awareness efforts (e) Awareness efforts (2) by striking (e) Construction (f) Construction

Summary: 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.