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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2547 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2547

 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.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 21, 2015

Mrs. McMorris Rodgers introduced the following bill; which was referred 
                to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Surrogate Endpoint Improvement and 
Utilization Act of 2015''.

SEC. 2. ACCELERATED APPROVAL DEVELOPMENT PLAN.

    (a) In General.--Section 506 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356) is amended by adding the following 
subsection:
    ``(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' means a development plan agreed upon 
        by the Secretary and the sponsor submitting the plan that 
        contains study parameters for the use of a surrogate endpoint 
        that--
                    ``(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) is amended--
            (1) by striking ``(f) Awareness Efforts'' and inserting 
        ``(e) Awareness Efforts''; and
            (2) by striking ``(e) Construction'' and inserting ``(f) 
        Construction''.
                                 <all>
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