I 
114TH CONGRESS 
1ST SESSION H. R. 2338 
To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
development and use of patient experience data to enhance the structured 
risk-benefit assessment framework, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 14, 2015 
Mr. PITTS 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 and use of patient experience 
data to enhance the structured risk-benefit assessment 
framework, 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. DEVELOPMENT AND USE OF PATIENT EXPERI-
ENCE DATA TO ENHANCE STRUCTURED RISK- 
BENEFIT ASSESSMENT FRAMEWORK. 
(a) IN GENERAL.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended— 
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(1) in subsection (d), by striking ‘‘The Sec-
retary shall implement’’ and all that follows through 
‘‘premarket approval of a drug.’’; and 
(2) by adding at the end the following new sub-
sections: 
‘‘(x) STRUCTURED
RISK-BENEFIT
ASSESSMENT 
FRAMEWORK.— 
‘‘(1) IN GENERAL.—The Secretary shall imple-
ment a structured risk-benefit assessment frame-
work in the new drug approval process— 
‘‘(A) to facilitate the balanced consider-
ation of benefits and risks; and 
‘‘(B) to develop and implement a con-
sistent and systematic approach to the discus-
sion of, regulatory decisionmaking with respect 
to, and the communication of, the benefits and 
risks of new drugs. 
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in 
paragraph (1) shall alter the criteria for evaluating 
an application for premarket approval of a drug. 
‘‘(y) DEVELOPMENT AND USE OF PATIENT EXPERI-
ENCE DATA TO ENHANCE STRUCTURED RISK-BENEFIT 
ASSESSMENT FRAMEWORK.— 
‘‘(1) IN GENERAL.—Not later than two years 
after the date of the enactment of this subsection, 
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the Secretary shall establish and implement proc-
esses under which— 
‘‘(A) an entity seeking to develop patient 
experience data may submit to the Secretary— 
‘‘(i) initial research concepts for feed-
back from the Secretary; and 
‘‘(ii) with respect to patient experience 
data collected by the entity, draft guidance 
documents, completed data, and sum-
maries and analyses of such data; 
‘‘(B) the Secretary may request such an 
entity to submit such documents, data, and 
summaries and analyses; and 
‘‘(C) patient experience data may be devel-
oped and used to enhance the structured risk- 
benefit assessment framework under subsection 
(x). 
‘‘(2) PATIENT EXPERIENCE DATA.—In this sub-
section, the term ‘patient experience data’ means 
data collected by patients, parents, caregivers, pa-
tient advocacy organizations, disease research foun-
dations, medical researchers, research sponsors or 
other parties determined appropriate by the Sec-
retary that is intended to facilitate or enhance the 
Secretary’s risk-benefit assessments, including infor-
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mation about the impact of a disease or a therapy 
on patients’ lives.’’. 
(b) GUIDANCE.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall publish guidance on the imple-
mentation of subsection (y) of section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), as added by subsection (a). Such guidance 
shall include— 
(A) with respect to draft guidance docu-
ments, data, or summaries and analyses sub-
mitted to the Secretary under paragraph (1)(A) 
of such subsection, guidance— 
(i) specifying the timelines for the re-
view of such documents, data, or sum-
maries and analyses by the Secretary; and 
(ii) on how the Secretary will use such 
documents, data, or summaries and anal-
yses to update any guidance documents 
published under this subsection or publish 
new guidance; 
(B) with respect to the collection and anal-
ysis of patient experience data (as defined in 
paragraph (2) of such subsection (y)), guidance 
on— 
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(2) TIMING.—Not later than three years after 
the date of the enactment of this Act, the Secretary 
of Health and Human Services shall issue draft 
guidance on the implementation of subsection (y) of 
section 505 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355), as added by subsection 
(a). The Secretary shall issue final guidance on the 
implementation of such subsection not later than one 
year after the date on which the comment period for 
the draft guidance closes. 
(3) WORKSHOPS.— 
(A) IN
GENERAL.—Not later than 6 
months after the date of the enactment of this 
Act and once every 6 months during the fol-
lowing 12-month period, the Secretary of 
Health and Human Services shall convene a 
workshop to obtain input regarding methodolo-
gies for developing the guidance under para-
graph (1), including the collection of patient ex-
perience data. 
(B) ATTENDEES.—A workshop convened 
under this paragraph shall include— 
(i) patients; 
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(ii) representatives from patient advo-
cacy organizations, biopharmaceutical com-
panies, and disease research foundations; 
(iii) representatives of the reviewing 
divisions of the Food and Drug Adminis-
tration; and 
(iv) methodological experts with sig-
nificant expertise in patient experience 
data. 
(4) PUBLIC MEETING.—Not later than 90 days 
after the date on which the draft guidance is pub-
lished under this subsection, the Secretary of Health 
and Human Services shall convene a public meeting 
to solicit input on the guidance. 
Æ 
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