I 
114TH CONGRESS 
1ST SESSION H. R. 2416 
To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential 
use of evidence from clinical experience to help support the approval 
of new indications for approved drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 19, 2015 
Mr. BURGESS 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 
evaluate the potential use of evidence from clinical expe-
rience to help support the approval of new indications 
for approved drugs, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. UTILIZING EVIDENCE FROM CLINICAL EXPERI-
ENCE. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 505E of such 
Act (21 U.S.C. 355f) the following: 
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‘‘SEC. 505F. UTILIZING EVIDENCE FROM CLINICAL EXPERI-
ENCE. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
program to evaluate the potential use of evidence from 
clinical experience— 
‘‘(1) to help support the approval of a new indi-
cation for a drug approved under section 505(b); 
and 
‘‘(2) to help support or satisfy post-approval 
study requirements. 
‘‘(b) EVIDENCE FROM CLINICAL EXPERIENCE DE-
FINED.—In this section, the term ‘evidence from clinical 
experience’ means data regarding the usage, or potential 
benefits or risks, of a drug derived from sources other 
than randomized clinical trials, including from observa-
tional studies, registries, and therapeutic use. 
‘‘(c) PROGRAM FRAMEWORK.— 
‘‘(1) IN GENERAL.—Not later than 18 months 
after the date of enactment of this section, the Sec-
retary shall establish a draft framework for imple-
mentation of the program under this section. 
‘‘(2) CONTENTS OF FRAMEWORK.—The frame-
work shall include information describing— 
‘‘(A) the current sources of data developed 
through clinical experience, including ongoing 
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safety surveillance, registry, claims, and pa-
tient-centered outcomes research activities; 
‘‘(B) the gaps in current data collection ac-
tivities; 
‘‘(C) the current standards and methodolo-
gies for collection and analysis of data gen-
erated through clinical experience; and 
‘‘(D) the priority areas, remaining chal-
lenges, and potential pilot opportunities that 
the program established under this section will 
address. 
‘‘(3) CONSULTATION.— 
‘‘(A) IN GENERAL.—In developing the pro-
gram framework under this subsection, the Sec-
retary shall consult with regulated industry, 
academia, medical professional organizations, 
representatives of patient advocacy organiza-
tions, disease research foundations, and other 
interested parties. 
‘‘(B) PROCESS.—The consultation under 
subparagraph (A) may be carried out through 
approaches such as— 
‘‘(i) a public-private partnership with 
the entities described in such subpara-
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graph, in which the Secretary may partici-
pate; or 
‘‘(ii) a contract, grant, or other ar-
rangement, as determined appropriate by 
the Secretary with such a partnership or 
an independent research organization. 
‘‘(d) PROGRAM IMPLEMENTATION.—The Secretary 
shall, not later than 24 months after the date of enact-
ment of this section and in accordance with the framework 
established under subsection (c), implement the program 
to evaluate the potential use of evidence from clinical expe-
rience. 
‘‘(e) GUIDANCE
FOR
INDUSTRY.—The Secretary 
shall— 
‘‘(1) utilize the program established in sub-
section (d), its activities, and any subsequent pilots 
or written reports, to inform a guidance for industry 
on— 
‘‘(A) the circumstances under which spon-
sors of drugs and the Secretary may rely on 
evidence from clinical experience for the pur-
poses described in subsections (a)(1) or (a)(2); 
and 
‘‘(B) the appropriate standards and meth-
odologies for collection and analysis of evidence 
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from clinical experience submitted for such pur-
poses; 
‘‘(2) not later than 36 months after the date of 
enactment of this section, issue draft guidance for 
industry as described in paragraph (1); and 
‘‘(3) not later than 48 months after the date of 
enactment of this section, after providing an oppor-
tunity for public comment on the draft guidance, 
issue final guidance. 
‘‘(f) RULE OF CONSTRUCTION.— 
‘‘(1) Subject to paragraph (2), nothing in this 
section prohibits the Secretary from using evidence 
from clinical experience for purposes not specified in 
this section, provided the Secretary determines that 
sufficient basis exists for any such non-specified use. 
‘‘(2) This section shall not be construed to 
alter— 
‘‘(A) the standards of evidence under— 
‘‘(i) subsection (c) or (d) of section 
505, including the substantial evidence 
standard in such subsection (d); or 
‘‘(ii) section 351(a) of the Public 
Health Service Act; or 
‘‘(B) the Secretary’s authority to require 
post-approval studies or clinical trials, or the 
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standards of evidence under which studies or 
trials are evaluated.’’. 
Æ 
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