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 medi-
cine through the establishment of a Regenerative Medi-
cine Coordinating Council, 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 Regenerative Medicine 4
Promotion Act of 2014. 5
SEC. 2. FINDINGS. 6
Congress finds the following: 7
(1) Regenerative medicine has the potential to 8
treat many chronic diseases, promote economic 9
VerDate Mar 15 2010 04:08 Mar 18, 2014 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\[Link] S2126
t
j
a
m
e
s
o
n
D
S
K
6
S
P
T
V
N
1
P
R
O
D
w
i
t
h
B
I
L
L
S
2
S 2126 IS
growth, and reduce health care spending in the 1
United States. 2
(2) Regenerative medicine products have al- 3
ready successfully treated numerous health condi- 4
tions and have the potential to provide cures, treat- 5
ments and diagnostics for a range of diseases and 6
disabilities including diabetes, spinal cord injury, 7
heart disease, stroke, various forms of cancer, and 8
other age-related conditions that represent a huge 9
quality of life, social, and economic burden on soci- 10
ety. 11
(3) A United States national strategy on regen- 12
erative medicine is critical to ensure that this tech- 13
nology fulfills its potential to cure and treat diseases 14
and disabilities, reduce overall health care spending, 15
and promote economic growth. 16
(4) The Department of Defense has stated that 17
regenerative medicine has the potential to treat 18
many battlefield injuries such as burns, that it has 19
the potential to heal wounds without scarring, and 20
that it has the potential to be used for craniofacial 21
reconstruction, limb reconstruction, regeneration, 22
and transplantation. 23
(5) The Department of Health and Human 24
Services and the Multi-Agency Tissue Engineering 25
VerDate Mar 15 2010 04:08 Mar 18, 2014 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\[Link] S2126
t
j
a
m
e
s
o
n
D
S
K
6
S
P
T
V
N
1
P
R
O
D
w
i
t
h
B
I
L
L
S
3
S 2126 IS
Science Interagency Working Group have endorsed a 1
national initiative to support research and product 2
development in regenerative medicine. 3
(6) The Department of Health and Human 4
Services has said the potential benefits of regenera- 5
tive medicine in improved health care and economic 6
savings are enormous. States that have invested in 7
regenerative medicine have experienced economic 8
growth and see future growth potential, including an 9
increase in biotech employment, payroll increases, 10
and proportional impacts on tax receipts. 11
SEC. 3. REPORT ON ONGOING FEDERAL PROGRAMS AND 12
ACTIVITIES REGARDING REGENERATIVE 13
MEDICINE. 14
Not later than 90 days after the date of the enact- 15
ment of this Act, the Comptroller General of the United 16
States shall provide for the completion, and submission 17
to Congress, of a report identifying all ongoing Federal 18
programs and activities regarding regenerative medicine. 19
SEC. 4. ESTABLISHMENT OF REGENERATIVE MEDICINE CO- 20
ORDINATING COUNCIL. 21
(a) [Link] Secretary of Health and 22
Human Services shall establish, in the Office of the Sec- 23
retary, a Regenerative Medicine Coordinating Council (in 24
this section referred to as the Council). 25
VerDate Mar 15 2010 04:08 Mar 18, 2014 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\[Link] S2126
t
j
a
m
e
s
o
n
D
S
K
6
S
P
T
V
N
1
P
R
O
D
w
i
t
h
B
I
L
L
S
4
S 2126 IS
(b) [Link] Council shall be composed 1
of the following: 2
(1) The Secretary of Commerce. 3
(2) The Secretary of Defense. 4
(3) The Secretary of Health and Human Serv- 5
ices. 6
(4) The Secretary of the Treasury. 7
(5) The Secretary of Veterans Affairs. 8
(6) The Administrator of the Agency for 9
Healthcare Research and Quality. 10
(7) The Administrator of the Centers for Medi- 11
care & Medicaid Services. 12
(8) The Commissioner of Food and Drugs. 13
(9) The Director of the National Institutes of 14
Health. 15
(10) The Director of the National Institutes of 16
Standards and Technology. 17
(11) Such other members as may be appointed 18
by the Secretary of Health and Human Services. 19
(c) [Link] Secretary of Health and Human 20
Services shall be the Chair of the Council. 21
(d) MEMBERS APPOINTED BY [Link] 22
members of the Council appointed by the Secretary of 23
Health and Human Services under subsection (b)(11) 24
shall include health insurers, regenerative medicine re- 25
VerDate Mar 15 2010 04:08 Mar 18, 2014 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\[Link] S2126
t
j
a
m
e
s
o
n
D
S
K
6
S
P
T
V
N
1
P
R
O
D
w
i
t
h
B
I
L
L
S
5
S 2126 IS
searchers from academic institutions, patient advocates, 1
persons with expertise in drug discovery, persons with ex- 2
pertise in drug development, persons with expertise in 3
basic research, persons with expertise in translational re- 4
search, persons with expertise in medical device develop- 5
ment, persons with expertise in biomaterials, and persons 6
with expertise in clinical research. 7
(e) [Link] Council shall 8
(1) prepare, and keep up-to-date, a national 9
strategy to support research into regenerative medi- 10
cine and enable the development of drugs, biological 11
products, medical devices, and biomaterials for use 12
in regenerative medicine; 13
(2) develop national goals for regenerative med- 14
icine research and product development; 15
(3) prepare a plan specifying priorities for re- 16
search into regenerative medicine; 17
(4) identify sources of funding for research into 18
regenerative medicine; 19
(5) identify areas where such funding is inad- 20
equate or duplicative; 21
(6) make recommendations regarding Federal 22
regulatory, reimbursement, and other policies that 23
will support development and marketing of regenera- 24
tive medicine products; 25
VerDate Mar 15 2010 04:08 Mar 18, 2014 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\[Link] S2126
t
j
a
m
e
s
o
n
D
S
K
6
S
P
T
V
N
1
P
R
O
D
w
i
t
h
B
I
L
L
S
6
S 2126 IS
(7) develop consensus standards regarding sci- 1
entific issues critical to regulatory approval of regen- 2
erative medicine products; and 3
(8) determine the need for establishing centers 4
of excellence or consortia to further advance regen- 5
erative medicine. 6
(f) TRANSPARENCY; REPORTING REQUIREMENTS. 7
(1) [Link] Council shall adopt 8
procedures to ensure the receipt of public input, 9
such as holding public stakeholder meetings or cre- 10
ating advisory boards. 11
(2) ANNUAL [Link] Council shall sub- 12
mit an annual report on its activities to Congress, 13
the Director of the National Institutes of Health, 14
and the Commissioner of Food and Drugs. Each 15
such report shall 16
(A) provide details on progress in meeting 17
goals identified by the Council for regenerative 18
medicine; 19
(B) provide recommendations regarding 20
funding, regulatory, or other policies to achieve 21
regenerative medicine goals identified by the 22
Council; 23
VerDate Mar 15 2010 04:08 Mar 18, 2014 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\[Link] S2126
t
j
a
m
e
s
o
n
D
S
K
6
S
P
T
V
N
1
P
R
O
D
w
i
t
h
B
I
L
L
S
7
S 2126 IS
(C) identify regenerative medicine products 1
currently on the market and those in develop- 2
ment; 3
(D) identify regenerative medicine research 4
and technological advances and discoveries that 5
occurred in the previous year; and 6
(E) assess the impact of regenerative medi- 7
cine on the Nations economy, including with 8
respect to 9
(i) the number of people employed in 10
companies or research institutions working 11
in regenerative medicine; 12
(ii) the number of companies pursuing 13
regenerative medicine products; and 14
(iii) increases in tax revenues. 15
VerDate Mar 15 2010 04:08 Mar 18, 2014 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\[Link] S2126
t
j
a
m
e
s
o
n
D
S
K
6
S
P
T
V
N
1
P
R
O
D
w
i
t
h
B
I
L
L
S