[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2338 Introduced in House (IH)]
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 Representatives of the
United States of America in Congress assembled,
SECTION 1. DEVELOPMENT AND USE OF PATIENT EXPERIENCE 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--
(1) in subsection (d), by striking ``The Secretary shall
implement'' and all that follows through ``premarket approval
of a drug.''; and
(2) by adding at the end the following new subsections:
``(x) Structured Risk-Benefit Assessment Framework.--
``(1) In general.--The Secretary shall implement a
structured risk-benefit assessment framework in the new drug
approval process--
``(A) to facilitate the balanced consideration of
benefits and risks; and
``(B) to develop and implement a consistent and
systematic approach to the discussion 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 Experience 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, the Secretary shall
establish and implement processes under which--
``(A) an entity seeking to develop patient
experience data may submit to the Secretary--
``(i) initial research concepts for
feedback from the Secretary; and
``(ii) with respect to patient experience
data collected by the entity, draft guidance
documents, completed data, and summaries 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 developed and
used to enhance the structured risk-benefit assessment
framework under subsection (x).
``(2) Patient experience data.--In this subsection, the
term `patient experience data' means data collected by
patients, parents, caregivers, patient advocacy organizations,
disease research foundations, medical researchers, research
sponsors or other parties determined appropriate by the
Secretary that is intended to facilitate or enhance the
Secretary's risk-benefit assessments, including information
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 implementation 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 documents, data,
or summaries and analyses submitted to the Secretary
under paragraph (1)(A) of such subsection, guidance--
(i) specifying the timelines for the review
of such documents, data, or summaries and
analyses by the Secretary; and
(ii) on how the Secretary will use such
documents, data, or summaries and analyses to
update any guidance documents published under
this subsection or publish new guidance;
(B) with respect to the collection and analysis of
patient experience data (as defined in paragraph (2) of
such subsection (y)), guidance on--
(i) methodological considerations for the
collection of patient experience data, which
may include structured approaches to gathering
information on--
(I) the experience of a patient
living with a particular disease;
(II) the burden of living with or
managing the disease;
(III) the impact of the disease on
daily life and long-term functioning;
and
(IV) the effect of current
therapeutic options on different
aspects of the disease; and
(ii) the establishment and maintenance of
registries designed to increase understanding
of the natural history of a disease;
(C) methodological approaches that may be used to
assess patients' beliefs with respect to the benefits
and risks in the management of the patient's disease;
and
(D) methodologies, standards, and potential
experimental designs for patient-reported outcomes.
(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
Cosmetic 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 following 12-month period, the
Secretary of Health and Human Services shall convene a
workshop to obtain input regarding methodologies for
developing the guidance under paragraph (1), including
the collection of patient experience data.
(B) Attendees.--A workshop convened under this
paragraph shall include--
(i) patients;
(ii) representatives from patient advocacy
organizations, biopharmaceutical companies, and
disease research foundations;
(iii) representatives of the reviewing
divisions of the Food and Drug Administration;
and
(iv) methodological experts with
significant expertise in patient experience
data.
(4) Public meeting.--Not later than 90 days after the date
on which the draft guidance is published under this subsection,
the Secretary of Health and Human Services shall convene a
public meeting to solicit input on the guidance.
<all>