[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2956 Introduced in Senate (IS)]
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115th CONGRESS
2d Session
S. 2956
To intensify stem cell research showing evidence of substantial
clinical benefit to patients, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 24, 2018
Mr. Wicker (for himself, Mr. Daines, Mr. Blunt, and Mr. Lankford)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To intensify stem cell research showing evidence of substantial
clinical benefit to patients, 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. SHORT TITLE.
This Act may be cited as the ``Patients First Act of 2018''.
SEC. 2. PURPOSES.
It is the purpose of this Act to--
(1) intensify research that may result in improved
understanding of or treatments for diseases and other adverse
health conditions;
(2) promote research and human clinical trials using stem
cells that are ethically obtained and show evidence of
providing clinical benefit for human patients; and
(3) promote the derivation of pluripotent stem cell lines
without the creation of human embryos for research purposes and
without the destruction or discarding of, or risk of injury to,
a human embryo.
SEC. 3. HUMAN STEM CELL RESEARCH AND THERAPY.
(a) Authorization.--Part B of title IV of the Public Health Service
Act (42 U.S.C. 284 et seq.) is amended by inserting after section 409J
the following:
``SEC. 409K. HUMAN STEM CELL RESEARCH AND THERAPY.
``(a) In General.--The Secretary shall conduct and support basic
and applied research to develop techniques for the isolation,
derivation, production, testing, and human clinical use of stem cells
that may result in improved understanding of, or treatments for,
diseases and other adverse health conditions, including pluripotent
stem cells that have the flexibility of embryonic stem cells (whether
or not such pluripotent stem cells have an embryonic source),
prioritizing research with the greatest potential for near-term
clinical benefit in human patients, provided that such isolation,
derivation, production, testing, or use will not involve--
``(1) the creation of a human embryo for research purposes;
``(2) the destruction of or discarding of, or risk of
injury to, a living human embryo; or
``(3) the use of any stem cell, the derivation or provision
of which would be inconsistent with the standards under
paragraph (1) or (2).
``(b) Guidelines.--Not later than 90 days after the date of the
enactment of this section, the Secretary, after consultation with the
Director of NIH, shall issue final guidelines implementing subsection
(a) to ensure that any research (including any clinical trial)
supported under subsection (a)--
``(1) is clearly consistent with the standards established
in subsection (a) if conducted using human cells, as
demonstrated by animal trials or other substantial evidence;
and
``(2) is prioritized in terms of potential for near-term
clinical benefit in human patients, as indicated by substantial
evidence from basic research or by substantial clinical
evidence, which may include--
``(A) evidence of improvement in one or more human
patients suffering from illness or injury, as
documented in reports by professional medical or
scientific associations or in peer-reviewed medical or
scientific literature; or
``(B) approval for use in human trials by the Food
and Drug Administration.
``(c) Definitions.--In this section:
``(1) Human embryo.--The term `human embryo' includes any
organism, not protected as a human subject under part 46 of
title 45, Code of Federal Regulations, as of the date of the
enactment of this section, that is derived by fertilization,
parthenogenesis, cloning, or any other means from one or more
human gametes or human diploid cells.
``(2) Risk of injury.--The term `risk of injury' means
subjecting a human embryo to risk of injury or death greater
than that allowed for research on fetuses in utero under
section 46.204(b) of title 45, Code of Federal Regulations (or
any successor regulation), or section 498(b) of this Act.''.
(b) Priority Setting; Reports.--Section 492 of the Public Health
Service Act (42 U.S.C. 289a) is amended by adding at the end the
following:
``(d)(1) With respect to human stem cell research, the Secretary,
acting through the Director of NIH, shall give priority to conducting
or supporting research in accordance with section 409K.
``(2) At the end of fiscal year 2018 and each subsequent fiscal
year, the Secretary shall submit to Congress a report outlining the
number of research proposals under section 409K that were peer
reviewed, a summary and detailed list of all such research proposals
that were not funded, and an explanation of why the proposals did not
merit funding. The reports under this paragraph shall be in addition to
the reporting on stem cell research included in the triennial report
required by section 403.''.
(c) Triennial Reports.--Section 403(a)(5) of the Public Health
Service Act (42 U.S.C. 283(a)(5)) is amended--
(1) by redesignating subparagraph (L) as subparagraph (M);
and
(2) by inserting after subparagraph (K) the following:
``(L) Stem cells.''.
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