113 S2126 IS: Regenerative Medicine Promotion Act of 2014
U.S. Senate
2014-03-13
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.
This Act may be cited as the
Regenerative Medicine Promotion Act of 2014
.
2.
Congress finds the following:
(1)
Regenerative medicine has the potential to
treat many chronic diseases, promote economic growth, and reduce health
care
spending in the United States.
(2)
Regenerative
medicine products have already successfully treated numerous health
conditions
and have the potential to provide cures, treatments and diagnostics for a
range
of diseases and disabilities including diabetes, spinal cord injury, heart
disease, stroke, various forms of cancer, and other age-related conditions
that
represent a huge quality of life, social, and economic burden on
society.
(3)
A United States
national strategy on regenerative medicine is critical to ensure that this
technology fulfills its potential to cure and treat diseases and
disabilities,
reduce overall health care spending, and promote economic growth.
(4)
The Department of
Defense has stated that regenerative medicine has the potential to treat
many
battlefield injuries such as burns, that it has the potential to heal
wounds
without scarring, and that it has the potential to be used for
craniofacial
reconstruction, limb reconstruction, regeneration, and transplantation.
(5)
The Department of Health and Human Services
and the Multi-Agency Tissue Engineering Science Interagency Working Group
have
endorsed a national initiative to support research and product development
in
regenerative medicine.
(6)
The Department of
Health and Human Services has said the potential benefits of regenerative
medicine in improved health care and economic savings are enormous. States
that
have invested in regenerative medicine have experienced economic growth
and see
future growth potential, including an increase in biotech employment,
payroll
increases, and proportional impacts on tax receipts.3.Report on ongoing
Federal programs and activities regarding regenerative medicineNot later than 90 days after the date of the
enactment of this Act, the Comptroller General of the United States shall
provide for the completion, and submission to Congress, of a report
identifying
all ongoing Federal programs and activities regarding regenerative
medicine.
4.
Establishment of
Regenerative Medicine Coordinating Council
(a)
The Secretary of Health and Human Services
shall establish, in the Office of the Secretary, a Regenerative Medicine
Coordinating Council (in this section referred to as the
Council
).
(b)
The Council shall be composed of the
following:
(1)
The Secretary of
Commerce.
(2)
The Secretary of
Defense.
(3)
The Secretary of Health and Human
Services.
(4)
The Secretary of
the Treasury.
(5)
The Secretary of
Veterans Affairs.
(6)
The Administrator
of the Agency for Healthcare Research and Quality.
(7)
The Administrator
of the Centers for Medicare & Medicaid Services.
(8)
The Commissioner
of Food and Drugs.
(9)
The Director of the National Institutes of
Health.
(10)
The Director of the National Institutes of
Standards and Technology.
(11)
Such other
members as may be appointed by the Secretary of Health and Human
Services.
(c)
The Secretary of Health and Human Services
shall be the Chair of the Council.
(d)
Members
appointed by Secretary
The
members of the Council appointed by the Secretary of Health and Human
Services
under subsection (b)(11) shall include health insurers, regenerative
medicine
researchers from academic institutions, patient advocates, persons with
expertise in drug discovery, persons with expertise in drug development,
persons with expertise in basic research, persons with expertise in
translational research, persons with expertise in medical device
development,
persons with expertise in biomaterials, and persons with expertise in
clinical
research.
(e)
The
Council shall—
(1)
prepare, and keep up-to-date, a national
strategy to support research into regenerative medicine and enable the
development of drugs, biological products, medical devices, and
biomaterials
for use in regenerative medicine;
(2)
develop national
goals for regenerative medicine research and product development;
(3)
prepare a plan
specifying priorities for research into regenerative medicine;
(4)
identify sources
of funding for research into regenerative medicine;
(5)
identify areas
where such funding is inadequate or duplicative;
(6)
make recommendations regarding Federal
regulatory, reimbursement, and other policies that will support
development and
marketing of regenerative medicine products;
(7)
develop consensus standards regarding
scientific issues critical to regulatory approval of regenerative medicine
products; and
(8)
determine the need
for establishing centers of excellence or consortia to further advance
regenerative medicine.
(f)
Transparency;
reporting requirements
(1)
The
Council shall adopt procedures to ensure the receipt of public input, such
as
holding public stakeholder meetings or creating advisory boards.
(2)
The Council shall
submit an annual report on its activities to Congress, the Director of the
National Institutes of Health, and the Commissioner of Food and Drugs.
Each
such report shall—
(A)
provide details on
progress in meeting goals identified by the Council for regenerative
medicine;
(B)
provide
recommendations regarding funding, regulatory, or other policies to
achieve
regenerative medicine goals identified by the Council;
(C)
identify
regenerative medicine products currently on the market and those in
development;
(D)
identify
regenerative medicine research and technological advances and discoveries
that
occurred in the previous year; and
(E)
assess the impact
of regenerative medicine on the Nation's economy, including with respect
to—
(i)
the
number of people employed in companies or research institutions working in
regenerative medicine;
(ii)
the
number of companies pursuing regenerative medicine products; and
(iii)
increases in tax
revenues.