I 

111TH CONGRESS 

1ST SESSION H. R. 877 

To intensify stem cell research showing evidence of substantial clinical benefit 

to patients, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 4, 2009 

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 2009’’. 

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; 


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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. 409J. 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— 


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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; 

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 


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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; and 

5 ‘‘(3) consistent with the standards established 

6 in subsection (a), may take into account techniques 

7 outlined by the President’s Council on Bioethics and 

8 any other appropriate techniques and research. 

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

10 ‘‘(1) HUMAN EMBRYO.—The term ‘human em11 bryo’ includes any organism, not protected as a 

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

13 Federal Regulations, as of the date of the enactment 

14 of this section, that is derived by fertilization, par15 thenogenesis, cloning, or any other means from one 

16 or more human gametes or human diploid cells. 

17 ‘‘(2) RISK OF INJURY.—The term ‘risk of in18 jury’ means subjecting a human embryo to risk of 

19 injury or death greater than that allowed for re20 search on fetuses in utero under section 46.204(b) 

21 of title 45, Code of Federal Regulations (or any suc22 cessor regulation), or section 498(b) of this Act.’’. 

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

24 the Public Health Service Act (42 U.S.C. 289a) is amend25 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 409J. 

5 ‘‘(2) At the end of fiscal year 2010 and each subse6 quent fiscal year, the Secretary shall submit to the Con7 gress a report outlining the number of research proposals 

8 under section 409J that were peer reviewed, a summary 

9 and detailed list of all such research proposals that were 

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

11 not merit funding. The reports under this paragraph shall 

12 be in addition to the reporting on stem cell research in13 cluded in the biennial report required by section 403.’’. 

14 (c) BIENNIAL 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.’’. 

22 SEC. 4. STUDY TO EXPAND ACCESS TO THERAPEUTIC STEM 

23 CELL PRODUCTS. 

24 Not later than 6 months after the date of the enact25 ment of this Act, the Secretary of Health and Human 


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1 Services shall study and submit recommendations to the 

2 Congress on any structural changes to the C.W. Bill 

3 Young Cell Transplantation Program established under 

4 379 of the Public Health Service Act (42 U.S.C. 274k) 

5 that would help to expand access to new and future stem 

6 cell therapeutic products, including stem cells derived from 

7 amniotic fluid as well as other sources such as dental pulp, 

8 nasal tissue, and fat that may benefit from inclusion in 

9 the coordinated distribution of bone marrow and cord 

10 blood stem cells. 

Æ 


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