[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2126 Introduced in Senate (IS)]

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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Regenerative Medicine Promotion Act 
of 2014''.

SEC. 2. FINDINGS.

    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.

SEC. 3. REPORT ON ONGOING FEDERAL PROGRAMS AND ACTIVITIES REGARDING 
              REGENERATIVE MEDICINE.

    Not 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.

SEC. 4. ESTABLISHMENT OF REGENERATIVE MEDICINE COORDINATING COUNCIL.

    (a) Establishment.--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) Composition.--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) Chair.--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) Functions.--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) Transparency.--The Council shall adopt procedures to 
        ensure the receipt of public input, such as holding public 
        stakeholder meetings or creating advisory boards.
            (2) Annual reports.--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.
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