II 

113TH CONGRESS 

2D SESSION S. 2126 

To launch a national strategy to support regenerative medicine through the 

establishment of a Regenerative Medicine Coordinating Council, and for 

other purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 13, 2014 

Mrs. BOXER (for herself and Mr. KIRK) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To launch a national strategy to support regenerative medicine through the establishment of a Regenerative Medicine Coordinating Council, 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 ‘‘Regenerative Medicine 

5 Promotion Act of 2014’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

8 (1) Regenerative medicine has the potential to 

9 treat many chronic diseases, promote economic 


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1 growth, and reduce health care spending in the 

2 United States. 

3 (2) Regenerative medicine products have al4 ready successfully treated numerous health condi5 tions and have the potential to provide cures, treat6 ments and diagnostics for a range of diseases and 

7 disabilities including diabetes, spinal cord injury, 

8 heart disease, stroke, various forms of cancer, and 

9 other age-related conditions that represent a huge 

10 quality of life, social, and economic burden on soci11 ety. 

12 (3) A United States national strategy on regen13 erative medicine is critical to ensure that this tech14 nology fulfills its potential to cure and treat diseases 

15 and disabilities, reduce overall health care spending, 

16 and promote economic growth. 

17 (4) The Department of Defense has stated that 

18 regenerative medicine has the potential to treat 

19 many battlefield injuries such as burns, that it has 

20 the potential to heal wounds without scarring, and 

21 that it has the potential to be used for craniofacial 

22 reconstruction, limb reconstruction, regeneration, 

23 and transplantation. 

24 (5) The Department of Health and Human 

25 Services and the Multi-Agency Tissue Engineering 


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1 Science Interagency Working Group have endorsed a 

2 national initiative to support research and product 

3 development in regenerative medicine. 

4 (6) The Department of Health and Human 

5 Services has said the potential benefits of regenera6 tive medicine in improved health care and economic 

7 savings are enormous. States that have invested in 

8 regenerative medicine have experienced economic 

9 growth and see future growth potential, including an 

10 increase in biotech employment, payroll increases, 

11 and proportional impacts on tax receipts. 

12 SEC. 3. REPORT ON ONGOING FEDERAL PROGRAMS AND 

13 ACTIVITIES REGARDING REGENERATIVE 

14 MEDICINE. 

15 Not later than 90 days after the date of the enact16 ment of this Act, the Comptroller General of the United 

17 States shall provide for the completion, and submission 

18 to Congress, of a report identifying all ongoing Federal 

19 programs and activities regarding regenerative medicine. 

20 SEC. 4. ESTABLISHMENT OF REGENERATIVE MEDICINE CO21 ORDINATING COUNCIL. 

22 (a) ESTABLISHMENT.—The Secretary of Health and 

23 Human Services shall establish, in the Office of the Sec24 retary, a Regenerative Medicine Coordinating Council (in 

25 this section referred to as the ‘‘Council’’). 


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1 (b) COMPOSITION.—The Council shall be composed 

2 of the following: 

3 (1) The Secretary of Commerce. 

4 (2) The Secretary of Defense. 

5 (3) The Secretary of Health and Human Serv6 ices. 

7 (4) The Secretary of the Treasury. 

8 (5) The Secretary of Veterans Affairs. 

9 (6) The Administrator of the Agency for 

10 Healthcare Research and Quality. 

11 (7) The Administrator of the Centers for Medi12 care & Medicaid Services. 

13 (8) The Commissioner of Food and Drugs. 

14 (9) The Director of the National Institutes of 

15 Health. 

16 (10) The Director of the National Institutes of 

17 Standards and Technology. 

18 (11) Such other members as may be appointed 

19 by the Secretary of Health and Human Services. 

20 (c) CHAIR.—The Secretary of Health and Human 

21 Services shall be the Chair of the Council. 

22 (d) MEMBERS APPOINTED BY SECRETARY.—The 

23 members of the Council appointed by the Secretary of 

24 Health and Human Services under subsection (b)(11) 

25 shall include health insurers, regenerative medicine reVerDate Mar 15 2010 04:08 Mar 18, 2014 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2126.IS S2126

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1 searchers from academic institutions, patient advocates, 

2 persons with expertise in drug discovery, persons with ex3 pertise in drug development, persons with expertise in 

4 basic research, persons with expertise in translational re5 search, persons with expertise in medical device develop6 ment, persons with expertise in biomaterials, and persons 

7 with expertise in clinical research. 

8 (e) FUNCTIONS.—The Council shall— 

9 (1) prepare, and keep up-to-date, a national 

10 strategy to support research into regenerative medi11 cine and enable the development of drugs, biological 

12 products, medical devices, and biomaterials for use 

13 in regenerative medicine; 

14 (2) develop national goals for regenerative med15 icine research and product development; 

16 (3) prepare a plan specifying priorities for re17 search into regenerative medicine; 

18 (4) identify sources of funding for research into 

19 regenerative medicine; 

20 (5) identify areas where such funding is inad21 equate or duplicative; 

22 (6) make recommendations regarding Federal 

23 regulatory, reimbursement, and other policies that 

24 will support development and marketing of regenera25 tive medicine products; 


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1 (7) develop consensus standards regarding sci2 entific issues critical to regulatory approval of regen3 erative medicine products; and 

4 (8) determine the need for establishing centers 

5 of excellence or consortia to further advance regen6 erative medicine. 

7 (f) TRANSPARENCY; REPORTING REQUIREMENTS.— 

8 (1) TRANSPARENCY.—The Council shall adopt 

9 procedures to ensure the receipt of public input, 

10 such as holding public stakeholder meetings or cre11 ating advisory boards. 

12 (2) ANNUAL REPORTS.—The Council shall sub13 mit an annual report on its activities to Congress, 

14 the Director of the National Institutes of Health, 

15 and the Commissioner of Food and Drugs. Each 

16 such report shall— 

17 (A) provide details on progress in meeting 

18 goals identified by the Council for regenerative 

19 medicine; 

20 (B) provide recommendations regarding 

21 funding, regulatory, or other policies to achieve 

22 regenerative medicine goals identified by the 

23 Council; 


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1 (C) identify regenerative medicine products 

2 currently on the market and those in develop3 ment; 

4 (D) identify regenerative medicine research 

5 and technological advances and discoveries that 

6 occurred in the previous year; and 

7 (E) assess the impact of regenerative medi8 cine on the Nation’s economy, including with 

9 respect to— 

10 (i) the number of people employed in 

11 companies or research institutions working 

12 in regenerative medicine; 

13 (ii) the number of companies pursuing 

14 regenerative medicine products; and 

15 (iii) increases in tax revenues. 

Æ 


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