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 de-
velopment plans for investigational drugs and biological 
products. 
Be it enacted by the Senate and House of Representa-
tives 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’’. 
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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 deter-
mined 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 uti-
lize the surrogate endpoint; and 
‘‘(C) the magnitude of the effect of the 
drug on the surrogate endpoint that is the sub-
ject of the agreement that would be sufficient 
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to form the primary basis of a claim that the 
drug is effective. 
‘‘(3) MODIFICATION; TERMINATION.—The Sec-
retary 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 ac-
celerated approval under subsection (c). 
‘‘(4) SPONSOR
CONSULTATION.—If the Sec-
retary requires the modification or termination of an 
accelerated approval development plan under para-
graph (3), the sponsor shall be granted a request for 
a meeting to discuss the basis of the Secretary’s de-
cision before the effective date of the modification or 
termination. 
‘‘(5) DEFINITION.—In this section, the term 
‘accelerated approval development plan’ means a de-
velopment plan agreed upon by the Secretary and 
the sponsor submitting the plan that contains study 
parameters for the use of a surrogate endpoint 
that— 
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‘‘(A) is reasonably likely to predict clinical 
benefit; and 
‘‘(B) is intended to be the basis of the ac-
celerated 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 in-
serting ‘‘(f) CONSTRUCTION’’. 
Æ 
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