I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Surrogate Endpoint 

5 Improvement and Utilization Act of 2015’’. 

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1 SEC. 2. ACCELERATED APPROVAL DEVELOPMENT PLAN. 

2 (a) IN GENERAL.—Section 506 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 356) is amended by 

4 adding the following subsection: 

5 ‘‘(g) ACCELERATED APPROVAL DEVELOPMENT

6 PLAN.— 

7 ‘‘(1) IN GENERAL.—In the case of a drug deter8 mined to be eligible for accelerated approval under 

9 subsection (c), at any time after the submission of 

10 an application for the investigation of the drug 

11 under section 505(i) of this Act or section 351(a)(3) 

12 of the Public Health Service Act, the sponsor of 

13 such drug may voluntarily request agreement by the 

14 Secretary to an accelerated approval development 

15 plan with respect to a surrogate endpoint to be used 

16 to study the drug. 

17 ‘‘(2) PLAN.—A plan described in paragraph (1) 

18 shall include agreement on— 

19 ‘‘(A) the surrogate endpoint to be assessed 

20 under the plan; 

21 ‘‘(B) the design of the study that will uti22 lize the surrogate endpoint; and 

23 ‘‘(C) the magnitude of the effect of the 

24 drug on the surrogate endpoint that is the sub25 ject of the agreement that would be sufficient 

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1 to form the primary basis of a claim that the 

2 drug is effective. 

3 ‘‘(3) MODIFICATION; TERMINATION.—The Sec4 retary may require the sponsor of a drug that is the 

5 subject of an accelerated approval development plan 

6 to modify or terminate the plan if additional data or 

7 information indicates that— 

8 ‘‘(A) the plan as originally agreed upon is 

9 no longer sufficient to demonstrate the safety 

10 and effectiveness of the drug involved; or 

11 ‘‘(B) the drug is no longer eligible for ac12 celerated approval under subsection (c). 

13 ‘‘(4) SPONSOR CONSULTATION.—If the Sec14 retary requires the modification or termination of an 

15 accelerated approval development plan under para16 graph (3), the sponsor shall be granted a request for 

17 a meeting to discuss the basis of the Secretary’s de18 cision before the effective date of the modification or 

19 termination. 

20 ‘‘(5) DEFINITION.—In this section, the term 

21 ‘accelerated approval development plan’ means a de22 velopment plan agreed upon by the Secretary and 

23 the sponsor submitting the plan that contains study 

24 parameters for the use of a surrogate endpoint 

25 that— 

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1 ‘‘(A) is reasonably likely to predict clinical 

2 benefit; and 

3 ‘‘(B) is intended to be the basis of the ac4 celerated approval of a drug under subsection 

5 (c).’’. 

6 (b) TECHNICAL AMENDMENTS.—Section 506 of the 

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) 

8 is amended— 

9 (1) by striking ‘‘(f) AWARENESS EFFORTS’’ and 

10 inserting ‘‘(e) AWARENESS EFFORTS’’; and 

11 (2) by striking ‘‘(e) CONSTRUCTION’’ and in12 serting ‘‘(f) CONSTRUCTION’’. 

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