I 

114TH CONGRESS 

1ST SESSION H. R. 2921 

To intensify stem cell research showing evidence of substantial clinical benefit 

to patients, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 25, 2015 

Mr. FORBES (for himself and Mr. LIPINSKI) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

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 2015’’. 

6 SEC. 2. PURPOSES. 

7 It is the purpose of this Act to— 

8 (1) intensify research that may result in im9 proved understanding of or treatments for diseases 

10 and other adverse health conditions; 


smartinez on DSK4TPTVN1PROD with BILLS
2 

•HR 2921 IH

1 (2) promote research and human clinical trials 

2 using stem cells that are ethically obtained and show 

3 evidence of providing clinical benefit for human pa4 tients; and 

5 (3) promote the derivation of pluripotent stem 

6 cell lines without the creation of human embryos for 

7 research purposes and without the destruction or 

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

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

10 (a) AUTHORIZATION.—Part B of title IV of the Pub11 lic Health Service Act (42 U.S.C. 284 et seq.) is amended 

12 by inserting after section 409I the following: 

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

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

15 support basic and applied research to develop techniques 

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

17 human clinical use of stem cells that may result in im18 proved understanding of or treatments for diseases and 

19 other adverse health conditions, including pluripotent stem 

20 cells that have the flexibility of embryonic stem cells 

21 (whether or not such pluripotent stem cells have an embry22 onic source), prioritizing research with the greatest poten23 tial for near-term clinical benefit in human patients, pro24 vided that such isolation, derivation, production, testing, 

25 or use will not involve— 


smartinez on DSK4TPTVN1PROD with BILLS
3 

•HR 2921 IH

1 ‘‘(1) the creation of a human embryo for re2 search purposes; 

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

4 of injury to, a living human embryo; or 

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

6 provision of which would be inconsistent with the 

7 standards established in paragraph (1) or (2). 

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

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

10 consultation with the Director of NIH, shall issue final 

11 guidelines implementing subsection (a) to ensure that any 

12 research (including any clinical trial) supported under 

13 subsection (a)— 

14 ‘‘(1) is clearly consistent with the standards es15 tablished in subsection (a) if conducted using human 

16 cells, as demonstrated by animal trials or other sub17 stantial evidence; and 

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

19 near-term clinical benefit in human patients, as indi20 cated by substantial evidence from basic research or 

21 by substantial clinical evidence which may include 

22 but is not limited to— 

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

24 more human patients suffering from illness or 

25 injury, as documented in reports by professional 


smartinez on DSK4TPTVN1PROD with BILLS
4 

•HR 2921 IH

1 medical or scientific associations or in peer-re2 viewed medical or scientific literature; or 

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

4 the Food and Drug Administration. 

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

6 ‘‘(1) HUMAN EMBRYO.—The term ‘human em7 bryo’ includes any organism, not protected as a 

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

9 Federal Regulations, as of the date of the enactment 

10 of this section, that is derived by fertilization, par11 thenogenesis, cloning, or any other means from one 

12 or more human gametes or human diploid cells. 

13 ‘‘(2) RISK OF INJURY.—The term ‘risk of in14 jury’ means subjecting a human embryo to risk of 

15 injury or death greater than that allowed for re16 search on fetuses in utero under section 46.204(b) 

17 of title 45, Code of Federal Regulations (or any suc18 cessor regulation), or section 498(b) of this Act.’’. 

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

20 the Public Health Service Act (42 U.S.C. 289a) is amend21 ed by adding at the end the following: 

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

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

24 priority to conducting or supporting research in accord25 ance with section 409K. 


smartinez on DSK4TPTVN1PROD with BILLS
5 

•HR 2921 IH

1 ‘‘(2) At the end of fiscal year 2016 and each subse2 quent fiscal year, the Secretary shall submit to the Con3 gress a report outlining the number of research proposals 

4 under section 409K that were peer reviewed, a summary 

5 and detailed list of all such research proposals that were 

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

7 not merit funding. The reports under this paragraph shall 

8 be in addition to the reporting on stem cell research in9 cluded in the biennial report required by section 403.’’. 

10 (c) BIENNIAL REPORTS.—Section 403(a)(5) of the 

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

12 amended— 

13 (1) by redesignating subparagraph (L) as sub14 paragraph (M); and 

15 (2) by inserting after subparagraph (K) the fol16 lowing: 

17 ‘‘(L) Stem cells.’’. 

Æ 


smartinez on DSK4TPTVN1PROD with BILLS