Patients First Act of 2019

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 substan- tial clinical benefit to patients, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Patients First Act of 4 2019’’. 5 SEC. 2. PURPOSES. 6 It is the purpose of this Act to— 7 VerDate Sep 11 2014 23:45 Aug 02, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2308.IS S2308 kjohnson on DSK79L0C42 with BILLS 2 •S 2308 IS (1) intensify research that may result in im- 1 proved understanding of or treatments for diseases 2 and other adverse health conditions; 3 (2) promote research and human clinical trials 4 using stem cells that are ethically obtained and show 5 evidence of providing clinical benefit for human pa- 6 tients; and 7 (3) promote the derivation of pluripotent stem 8 cell lines without the creation of human embryos for 9 research purposes and without the destruction or 10 discarding of, or risk of injury to, a human embryo. 11 SEC. 3. HUMAN STEM CELL RESEARCH AND THERAPY. 12 (a) AUTHORIZATION.—Part B of title IV of the Pub- 13 lic Health Service Act (42 U.S.C. 284 et seq.) is amended 14 by inserting after section 409J the following: 15 ‘‘SEC. 409K. HUMAN STEM CELL RESEARCH AND THERAPY. 16 ‘‘(a) IN GENERAL.—The Secretary shall conduct and 17 support basic and applied research to develop techniques 18 for the isolation, derivation, production, testing, and 19 human clinical use of stem cells that may result in im- 20 proved understanding of, or treatments for, diseases and 21 other adverse health conditions, including pluripotent stem 22 cells that have the flexibility of embryonic stem cells 23 (whether or not such pluripotent stem cells have an embry- 24 onic source), prioritizing research with the greatest poten- 25 VerDate Sep 11 2014 23:45 Aug 02, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2308.IS S2308 kjohnson on DSK79L0C42 with BILLS 3 •S 2308 IS tial for near-term clinical benefit in human patients, pro- 1 vided that such isolation, derivation, production, testing, 2 or use will not involve— 3 ‘‘(1) the creation of a human embryo for re- 4 search purposes; 5 ‘‘(2) the destruction of or discarding of, or risk 6 of injury to, a living human embryo; or 7 ‘‘(3) the use of any stem cell, the derivation or 8 provision of which would be inconsistent with the 9 standards under paragraph (1) or (2). 10 ‘‘(b) GUIDELINES.—Not later than 90 days after the 11 date of the enactment of this section, the Secretary, after 12 consultation with the Director of NIH, shall issue final 13 guidelines implementing subsection (a) to ensure that any 14 research (including any clinical trial) supported under 15 subsection (a)— 16 ‘‘(1) is clearly consistent with the standards es- 17 tablished in subsection (a) if conducted using human 18 cells, as demonstrated by animal trials or other sub- 19 stantial evidence; and 20 ‘‘(2) is prioritized in terms of potential for 21 near-term clinical benefit in human patients, as indi- 22 cated by substantial evidence from basic research or 23 by substantial clinical evidence, which may include— 24 VerDate Sep 11 2014 23:45 Aug 02, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2308.IS S2308 kjohnson on DSK79L0C42 with BILLS 4 •S 2308 IS ‘‘(A) evidence of improvement in one or 1 more human patients suffering from illness or 2 injury, as documented in reports by professional 3 medical or scientific associations or in peer-re- 4 viewed medical or scientific literature; or 5 ‘‘(B) approval for use in human trials by 6 the Food and Drug Administration. 7 ‘‘(c) DEFINITIONS.—In this section: 8 ‘‘(1) HUMAN EMBRYO.—The term ‘human em- 9 bryo’ includes any organism, not protected as a 10 human subject under part 46 of title 45, Code of 11 Federal Regulations, as of the date of the enactment 12 of this section, that is derived by fertilization, par- 13 thenogenesis, cloning, or any other means from one 14 or more human gametes or human diploid cells. 15 ‘‘(2) RISK OF INJURY.—The term ‘risk of in- 16 jury’ means subjecting a human embryo to risk of 17 injury or death greater than that allowed for re- 18 search on fetuses in utero under section 46.204(b) 19 of title 45, Code of Federal Regulations (or any suc- 20 cessor regulation), or section 498(b) of this Act.’’. 21 (b) PRIORITY SETTING; REPORTS.—Section 492 of 22 the Public Health Service Act (42 U.S.C. 289a) is amend- 23 ed by adding at the end the following: 24 VerDate Sep 11 2014 23:45 Aug 02, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2308.IS S2308 kjohnson on DSK79L0C42 with BILLS 5 •S 2308 IS ‘‘(d)(1) With respect to human stem cell research, the 1 Secretary, acting through the Director of NIH, shall give 2 priority to conducting or supporting research in accord- 3 ance with section 409K. 4 ‘‘(2) At the end of fiscal year 2019 and each subse- 5 quent fiscal year, the Secretary shall submit to Congress 6 a report outlining the number of research proposals under 7 section 409K that were peer reviewed, a summary and de- 8 tailed list of all such research proposals that were not 9 funded, and an explanation of why the proposals did not 10 merit funding. The reports under this paragraph shall be 11 in addition to the reporting on stem cell research included 12 in the triennial report required by section 403.’’. 13 (c) TRIENNIAL REPORTS.—Section 403(a)(5) of the 14 Public Health Service Act (42 U.S.C. 283(a)(5)) is 15 amended— 16 (1) by redesignating subparagraph (L) as sub- 17 paragraph (M); and 18 (2) by inserting after subparagraph (K) the fol- 19 lowing: 20 ‘‘(L) Stem cells.’’. 21 Æ VerDate Sep 11 2014 23:45 Aug 02, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S2308.IS S2308 kjohnson on DSK79L0C42 with BILLS