II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Patients First Act of 

5 2019’’. 

6 SEC. 2. PURPOSES. 

7 It is the purpose of this Act to— 


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1 (1) intensify research that may result in im2 proved understanding of or treatments for diseases 

3 and other adverse health conditions; 

4 (2) promote research and human clinical trials 

5 using stem cells that are ethically obtained and show 

6 evidence of providing clinical benefit for human pa7 tients; and 

8 (3) promote the derivation of pluripotent stem 

9 cell lines without the creation of human embryos for 

10 research purposes and without the destruction or 

11 discarding of, or risk of injury to, a human embryo. 

12 SEC. 3. HUMAN STEM CELL RESEARCH AND THERAPY. 

13 (a) AUTHORIZATION.—Part B of title IV of the Pub14 lic Health Service Act (42 U.S.C. 284 et seq.) is amended 

15 by inserting after section 409J the following: 

16 ‘‘SEC. 409K. HUMAN STEM CELL RESEARCH AND THERAPY. 

17 ‘‘(a) IN GENERAL.—The Secretary shall conduct and 

18 support basic and applied research to develop techniques 

19 for the isolation, derivation, production, testing, and 

20 human clinical use of stem cells that may result in im21 proved understanding of, or treatments for, diseases and 

22 other adverse health conditions, including pluripotent stem 

23 cells that have the flexibility of embryonic stem cells 

24 (whether or not such pluripotent stem cells have an embry25 onic source), prioritizing research with the greatest potenVerDate Sep 11 2014 23:45 Aug 02, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2308.IS S2308

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1 tial for near-term clinical benefit in human patients, pro2 vided that such isolation, derivation, production, testing, 

3 or use will not involve— 

4 ‘‘(1) the creation of a human embryo for re5 search purposes; 

6 ‘‘(2) the destruction of or discarding of, or risk 

7 of injury to, a living human embryo; or 

8 ‘‘(3) the use of any stem cell, the derivation or 

9 provision of which would be inconsistent with the 

10 standards under paragraph (1) or (2). 

11 ‘‘(b) GUIDELINES.—Not later than 90 days after the 

12 date of the enactment of this section, the Secretary, after 

13 consultation with the Director of NIH, shall issue final 

14 guidelines implementing subsection (a) to ensure that any 

15 research (including any clinical trial) supported under 

16 subsection (a)— 

17 ‘‘(1) is clearly consistent with the standards es18 tablished in subsection (a) if conducted using human 

19 cells, as demonstrated by animal trials or other sub20 stantial evidence; and 

21 ‘‘(2) is prioritized in terms of potential for 

22 near-term clinical benefit in human patients, as indi23 cated by substantial evidence from basic research or 

24 by substantial clinical evidence, which may include— 


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1 ‘‘(A) evidence of improvement in one or 

2 more human patients suffering from illness or 

3 injury, as documented in reports by professional 

4 medical or scientific associations or in peer-re5 viewed medical or scientific literature; or 

6 ‘‘(B) approval for use in human trials by 

7 the Food and Drug Administration. 

8 ‘‘(c) DEFINITIONS.—In this section: 

9 ‘‘(1) HUMAN EMBRYO.—The term ‘human em10 bryo’ includes any organism, not protected as a 

11 human subject under part 46 of title 45, Code of 

12 Federal Regulations, as of the date of the enactment 

13 of this section, that is derived by fertilization, par14 thenogenesis, cloning, or any other means from one 

15 or more human gametes or human diploid cells. 

16 ‘‘(2) RISK OF INJURY.—The term ‘risk of in17 jury’ means subjecting a human embryo to risk of 

18 injury or death greater than that allowed for re19 search on fetuses in utero under section 46.204(b) 

20 of title 45, Code of Federal Regulations (or any suc21 cessor regulation), or section 498(b) of this Act.’’. 

22 (b) PRIORITY SETTING; REPORTS.—Section 492 of 

23 the Public Health Service Act (42 U.S.C. 289a) is amend24 ed by adding at the end the following: 


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1 ‘‘(d)(1) With respect to human stem cell research, the 

2 Secretary, acting through the Director of NIH, shall give 

3 priority to conducting or supporting research in accord4 ance with section 409K. 

5 ‘‘(2) At the end of fiscal year 2019 and each subse6 quent fiscal year, the Secretary shall submit to Congress 

7 a report outlining the number of research proposals under 

8 section 409K that were peer reviewed, a summary and de9 tailed list of all such research proposals that were not 

10 funded, and an explanation of why the proposals did not 

11 merit funding. The reports under this paragraph shall be 

12 in addition to the reporting on stem cell research included 

13 in the triennial report required by section 403.’’. 

14 (c) TRIENNIAL REPORTS.—Section 403(a)(5) of the 

15 Public Health Service Act (42 U.S.C. 283(a)(5)) is 

16 amended— 

17 (1) by redesignating subparagraph (L) as sub18 paragraph (M); and 

19 (2) by inserting after subparagraph (K) the fol20 lowing: 

21 ‘‘(L) Stem cells.’’. 

Æ 


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