I
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 Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Pharmaceutical Test-
ing Fairness Act’’.
SEC. 2. NEW DRUG CLINICAL INVESTIGATIONS.
Section 505(b) of the Federal Food, Drug, and Cos-
metic 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 sub-
jects 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 estab-
lish 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 inclu-
sion is not a permissible consideration in determin-
ing 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 in-
vestigation, and
‘‘(iii) may provide that such inclusion is not re-
quired if there is substantial scientific data dem-
onstrating that there is no significant difference be-
tween the effects that the variables to be studied in
the investigation have on women or members of mi-
nority groups, respectively, and on the other individ-
uals who would serve as subjects in the investigation
in the event that the inclusion of women and mem-
bers 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 investiga-
tions to be so designed, such other phases shall be so de-
signed.’’.
SEC. 3. DEVICE CLINICAL INVESTIGATIONS.
Section 515(c) of the Federal Food, Drug, and Cos-
metic 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 in-
clude 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).