[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2695 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 2695

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
    Service Act to require the inclusion of women and minorities in 
clinical investigations of new drugs, biological products, and medical 
                                devices.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 21, 1993

  Mrs. Schroeder (for herself and Ms. Snowe) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
    Service Act to require the inclusion of women and minorities in 
clinical investigations of new drugs, biological products, and medical 
                                devices.

    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 ``Pharmaceutical Testing Fairness 
Act''.

SEC. 2. NEW DRUG CLINICAL INVESTIGATIONS.

    Section 505(b) of the Federal Food, Drug, and Cosmetic Act is 
amended by adding at the end the following:
    ``(4)(A) Clinical investigations submitted as part of an 
application in accordance with paragraph (1)(A) shall include women and 
members of minority groups as subjects of such investigations unless 
the inclusion of women and minority groups is inappropriate with 
respect to the drug under investigation or is otherwise inappropriate 
under such guidelines as the Secretary shall by rule establish in 
accordance with subparagraph (B).
    ``(B) The guidelines of the Secretary respecting the inclusion of 
women and members of minority groups in clinical investigations--
            ``(i) shall provide that the costs of such inclusion is not 
        a permissible consideration in determining whether such 
        inclusion is inappropriate,
            ``(ii) shall provide that women or minority groups are not 
        required to be included if women or minority groups will not be 
        using the drug under investigation, and
            ``(iii) may provide that such inclusion is not required if 
        there is substantial scientific data demonstrating that there 
        is no significant difference between the effects that the 
        variables to be studied in the investigation have on women or 
        members of minority groups, respectively, and on the other 
        individuals who would serve as subjects in the investigation in 
        the event that the inclusion of women and members of minority 
        groups was not required.
    ``(C) Phase three clinical investigations which are submitted as 
part of an application in accordance with paragraph (1)(A) shall be 
designed so that there is a valid analysis of whether the drug under 
investigation affects women or members of minority groups differently 
than other users of the drug. If the Secretary determines that it would 
be appropriate for other phases of such investigations to be so 
designed, such other phases shall be so designed.''.

SEC. 3. DEVICE CLINICAL INVESTIGATIONS.

    Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e(c)) is amended by adding at the end the following:
    ``(3)(A) Clinical investigations submitted as part of an 
application in accordance with paragraph (1) shall include women and 
members of minority groups as subjects of such investigations unless 
the inclusion of women and minority groups is inappropriate with 
respect to the device under investigation or is otherwise inappropriate 
under such guidelines as the Secretary shall by rule establish in 
accordance with subparagraph (B).
    ``(B) The guidelines of the Secretary respecting the inclusion of 
women and members of minority groups in clinical investigations--
            ``(i) shall provide that the costs of such inclusion is not 
        a permissible consideration in determining whether such 
        inclusion is inappropriate,
            ``(ii) shall provide that women or minority groups are not 
        required to be included if women or minority groups will not be 
        using the device under investigation, and
            ``(iii) may provide that such inclusion is not required if 
        there is substantial scientific data demonstrating that there 
        is no significant difference between the effects that the 
        variables to be studied in the investigation have on women or 
        members of minority groups, respectively, and on the other 
        individuals who would serve as subjects in the investigation in 
        the event that the inclusion of women and members of minority 
        groups was not required.
    ``(C)(i) Clinical investigations designated by the Secretary under 
clause (ii) which are submitted as part of an application in accordance 
with paragraph (1) shall be designed so that there is a valid analysis 
of whether the device under investigation affects women or members of 
minority groups differently than other users of the device.
    ``(ii) The Secretary shall designate which of the clinical 
investigations submitted as part of an application under paragraph (1) 
shall be subject to the requirement of clause (i).''.

SEC. 5. BIOLOGICAL PRODUCTS CLINICAL INVESTIGATIONS.  

    Section 351(c) of the Public Health Service Act (42 U.S.C. 262(c)) 
is amended by adding at the end the following:
    ``(3)(A) Clinical investigations submitted as part of an 
application in accordance with paragraph (1) shall include women and 
members of minority groups as subjects of such investigations unless 
the inclusion of women and minority groups is inappropriate with 
respect to the biological product under investigation or is otherwise 
inappropriate under such guidelines as the Secretary shall by rule 
establish in accordance with subparagraph (B).
    ``(B) The guidelines of the Secretary respecting the inclusion of 
women and members of minority groups in clinical investigations--
            ``(i) shall provide that the costs of such inclusion is not 
        a permissible consideration in determining whether such 
        inclusion is inappropriate,
            ``(ii) shall provide that women or minority groups are not 
        required to be included if women or minority groups will not be 
        using the biological product under investigation, and
            ``(iii) may provide that such inclusion is not required if 
        there is substantial scientific data demonstrating that there 
        is no significant difference between the effects that the 
        variables to be studied in the investigation have on women or 
        members of minority groups, respectively, and on the other 
        individuals who would serve as subjects in the investigation in 
        the event that the inclusion of women and members of minority 
        groups was not required.
    ``(C)(i) Clinical investigations designated by the Secretary under 
clause (ii) which are submitted as part of an application in accordance 
with paragraph (1) shall be designed so that there is a valid analysis 
of whether the device under investigation affects women or members of 
minority groups differently than other users of the device.
    ``(ii) The Secretary shall designate which of the clinical 
investigations submitted as part of an application under paragraph (1) 
shall be subject to the requirement of clause (i).''.

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