[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2689 Introduced in Senate (IS)]

<DOC>






114th CONGRESS
  2d Session
                                S. 2689

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                          cellular therapies.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 16, 2016

  Mr. Kirk (for himself, Mr. Manchin, and Ms. Collins) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                          cellular therapies.

    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 ``Reliable and Effective Growth for 
Regenerative Health Options that Improve Wellness'' or the ``REGROW 
Act''.

SEC. 2. CELLULAR THERAPEUTICS.

    (a) Current Pathways.--Nothing in this Act, or the amendments made 
by this Act, shall be applied or interpreted as restricting or 
otherwise modifying any pathway to market which is (as of the day 
immediately before the date of enactment of this Act) provided under 
regulations promulgated by the Food and Drug Administration, including 
pathways under sections 351 and 361 of the Public Health Service Act 
(42 U.S.C. 262 and 264).
    (b) Approval for Therapies.--Subpart 1 of part F of title III of 
the Public Health Service Act (42 U.S.C. 262 et seq.) is amended by 
adding after section 351A the following:

``SEC. 351B. APPROVAL FOR CELLULAR THERAPIES.

    ``(a) Conditional Approval of Cellular or Tissue Therapeutic.--Not 
later than 1 year after the date of enactment of this section, the 
Secretary shall establish a program to conditionally approve a cellular 
therapeutic product if the sponsor of such product demonstrates 
preliminary clinical evidence of safety, and a reasonable expectation 
of effectiveness, without initiation of phase III investigations.
    ``(b) Additional Requirements for Conditional Approval.--A 
conditionally approved product under subsection (a) shall, for a 5-year 
conditional use period, be manufactured, introduced into interstate 
commerce, and used consistent with the regulations in effect at the 
time of such use, including good manufacturing practices, without the 
approval of an application under section 351(a), if all of the 
following apply:
            ``(1) Such cells or tissues are adult human cells or 
        tissues.
            ``(2) Such cells or tissues have been evaluated to examine 
        immunogenicity and do not provoke a significant unintended 
        immune response in the recipient.
            ``(3) Such cells or tissues are--
                    ``(A) minimally manipulated for a nonhomologous 
                use; or
                    ``(B) more-than-minimally manipulated for a 
                homologous or nonhomologous use, but are not 
                genetically modified.
            ``(4) Such cells or tissues are produced for a specific 
        indication.
            ``(5) Such cells or tissues are produced exclusively for a 
        use that performs, or helps achieve or restore, the same, or 
        similar, function in the recipient as in the donor.
            ``(6) Within 5 years of the safety and effectiveness 
        determination described in this section, the sponsor of the 
        conditionally approved new product prepares and submits an 
        application for approval of a biological product under section 
        351(a), demonstrating potency, purity, safety, and efficacy of 
        the use. The Secretary may permit continued use of such product 
        until the Secretary completes the review of the application and 
        makes a determination. Upon a determination by the Secretary 
        not to approve the application, use of the cellular therapeutic 
        shall not be permitted.
            ``(7) During the conditional approval period, and before 
        approval of an application under section 351(a), the sponsor 
        shall prepare and submit annual reports and adverse event 
        reports to the Secretary containing all the information 
        required for approved biological products.
            ``(8) The sponsor has submitted an application under 
        section 505(i) of the Federal Food, Drug, and Cosmetic Act for 
        the treatment of the patients during the 5-year conditional use 
        period.
            ``(9) The sponsor has not previously received conditional 
        approval for such product for the same indication.
    ``(c) Informed Use.--The individual administering a product 
approved under subsection (b) shall inform each individual who uses 
such product that the product has been conditionally approved based on 
studies in a limited population, without proof of efficacy, and that 
the Secretary is requiring additional studies of the product.
    ``(d) Stem Cell Banking.--To be eligible to provide cells for the 
uses described under subsection (b), public and private cord blood 
banks, tissue banks, and bone marrow repositories shall be in full 
compliance with good tissue practice requirements under part 1271 of 
title 21, Code of Federal Regulations (or successor regulations), as 
applicable.''.

SEC. 3. DEVICES USED IN RECOVERY, PROCESSING, AND DELIVERY OF CELLULAR 
              THERAPEUTICS.

    (a) Clearance.--Section 510(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(k)) is amended--
            (1) in paragraph (1), by striking ``, and'' and inserting 
        ``;'';
            (2) in paragraph (2), by striking the period and inserting 
        ``; and''; and
            (3) by inserting after paragraph (2) the following:
            ``(3) in the case of a cellular therapeutic described in 
        section 351B(a) of the Public Health Service Act, the general 
        function of the device used for the recovery, isolation, 
        processing, or delivery of such cellular therapeutic.''.
    (b) Clearance or Approval of Cellular Therapeutics.--Chapter V of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is 
amended by inserting after section 515A the following:

``SEC. 515B. CLASSIFICATION OF CELLULAR THERAPEUTICS.

    ``Clearance or approval of a device that is a cellular therapeutic 
described in section 351B(a) of the Public Health Service Act shall be 
based on in vitro performance testing and not in vivo human clinical 
trials, as appropriate. The Secretary shall classify devices in 
accordance with section 513 used for cell therapy (as described in 
section 351B(a) of the Public Health Service Act), focusing on the 
general use of such devices for harvesting, delivery, or processing 
cells and sustaining the viability and functions of the cells in vivo. 
The classification regulation shall not require that such devices be 
cleared under section 510(k) or approved under section 515 for use with 
only specific types of cells or for specific uses unless unique to the 
intended use of the device. If the Secretary determines that no 
predicate exists, or that a device classified as class III is 
sufficiently low risk to justify a lower classification, the Secretary 
shall apply the procedure outlined in section 513(f)(2) to permit the 
review and marketing of the device.''.
    (c) Combination Products.--Section 503(g)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353(g)(1)) is amended--
            (1) in subparagraph (B), by striking ``or'';
            (2) in subparagraph (C), by striking the period and 
        inserting ``, or''; and
            (3) by adding at the end the following:
            ``(D) cellular components, the agency center charged with 
        premarket review of biological products shall have primary 
        jurisdiction.''.

SEC. 4. GUIDANCE; AMENDED REGULATIONS.

    (a) Guidance.--Within 1 year of the date of enactment of this Act, 
the Secretary of Health and Human Services (referred to in this section 
as the ``Secretary'') may issue draft guidance on clarifying the 
requirements with respect to cellular therapeutics, as set forth in 
section 351B of the Public Health Service Act, as added by section 2, 
and devices used in processing or delivery of cellular therapeutics, as 
set forth in section 510(k)(3) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360(k)(3)) and section 515B of such Act, as added by 
section 3(b). The Secretary shall issue final guidance not later than 
180 days after the close of the comment period (including any 
extensions of such period) for the draft guidance. Such comment period 
may not exceed 60 days.
    (b) Amended Regulations.--
            (1) In general.--If the Secretary determines that it is 
        appropriate to amend the regulations under title 21, Code of 
        Federal Regulations, in order to clarify the requirements of 
        section 351B of the Public Health Service Act, as added by 
        section 2, the Secretary shall amend such regulations not later 
        than 1 year after the date of enactment of this Act.
            (2) Procedure.--In amending regulations under paragraph 
        (1), the Secretary shall--
                    (A) issue a notice of proposed rulemaking that 
                includes the proposed regulations;
                    (B) provide a period of not more than 60 days for 
                comments on the proposed regulations; and
                    (C) publish the final regulations not less than 30 
                days before the effective date of such regulations.
    (c) Public Meeting.--In carrying out this Act, including the 
amendment made by section 2 and the amendments made by section 3, the 
Secretary, not later than 90 days after the date of enactment of this 
Act, shall have not less than 1 public meeting on the relevant 
regulatory policies relating to cell and tissue products, including any 
changes to such policies necessary to encourage innovation and 
regulatory certainty with regard to the development of regenerative 
medicine products.

SEC. 5. REGENERATIVE MEDICINE STANDARDS.

    The Secretary shall work with stakeholders, including regenerative 
product manufacturers, academic institutions, standards setting 
organizations, and the National Institute of Standards and Technology, 
to promote and facilitate an effort to develop, through a transparent 
public process, standards that will facilitate regulatory 
predictability regarding manufacturing processes and controls for 
regenerative medicine products.
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