[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2308 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  1st Session
                                S. 2308

    To intensify stem cell research showing evidence of substantial 
         clinical benefit to patients, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 29, 2019

Mr. Wicker (for himself, Mr. Lankford, Mrs. Hyde-Smith, Mr. Blunt, Mrs. 
     Blackburn, Mr. Daines, Mr. Inhofe, Ms. Ernst, and Mr. Cramer) 
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 2019''.

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 2019 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.''.
                                 <all>