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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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Pharmaceutical Test5 ing Fairness Act’’.

6 SEC. 2. NEW DRUG CLINICAL INVESTIGATIONS.

7 Section 505(b) of the Federal Food, Drug, and Cos8 metic Act is amended by adding at the end the following:
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1 ‘‘(4)(A) Clinical investigations submitted as part of

2 an application in accordance with paragraph (1)(A) shall

3 include women and members of minority groups as sub4 jects of such investigations unless the inclusion of women

5 and minority groups is inappropriate with respect to the

6 drug under investigation or is otherwise inappropriate

7 under such guidelines as the Secretary shall by rule estab8 lish in accordance with subparagraph (B).

9 ‘‘(B) The guidelines of the Secretary respecting the

10 inclusion of women and members of minority groups in

11 clinical investigations—

12 ‘‘(i) shall provide that the costs of such inclu13 sion is not a permissible consideration in determin14 ing whether such inclusion is inappropriate,

15 ‘‘(ii) shall provide that women or minority

16 groups are not required to be included if women or

17 minority groups will not be using the drug under in18 vestigation, and

19 ‘‘(iii) may provide that such inclusion is not re20 quired if there is substantial scientific data dem21 onstrating that there is no significant difference be22 tween the effects that the variables to be studied in

23 the investigation have on women or members of mi24 nority groups, respectively, and on the other individ25 uals who would serve as subjects in the investigation
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1 in the event that the inclusion of women and mem2 bers of minority groups was not required.

3 ‘‘(C) Phase three clinical investigations which are

4 submitted as part of an application in accordance with

5 paragraph (1)(A) shall be designed so that there is a valid

6 analysis of whether the drug under investigation affects

7 women or members of minority groups differently than

8 other users of the drug. If the Secretary determines that

9 it would be appropriate for other phases of such investiga10 tions to be so designed, such other phases shall be so de11 signed.’’.

12 SEC. 3. DEVICE CLINICAL INVESTIGATIONS.

13 Section 515(c) of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 360e(c)) is amended by adding at

15 the end the following:

16 ‘‘(3)(A) Clinical investigations submitted as part of

17 an application in accordance with paragraph (1) shall in18 clude women and members of minority groups as subjects

19 of such investigations unless the inclusion of women and

20 minority groups is inappropriate with respect to the device

21 under investigation or is otherwise inappropriate under

22 such guidelines as the Secretary shall by rule establish in

23 accordance with subparagraph (B).
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1 ‘‘(B) The guidelines of the Secretary respecting the

2 inclusion of women and members of minority groups in

3 clinical investigations—

4 ‘‘(i) shall provide that the costs of such inclu5 sion is not a permissible consideration in determin6 ing whether such inclusion is inappropriate,

7 ‘‘(ii) shall provide that women or minority

8 groups are not required to be included if women or

9 minority groups will not be using the device under

10 investigation, and

11 ‘‘(iii) may provide that such inclusion is not re12 quired if there is substantial scientific data dem13 onstrating that there is no significant difference be14 tween the effects that the variables to be studied in

15 the investigation have on women or members of mi16 nority groups, respectively, and on the other individ17 uals who would serve as subjects in the investigation

18 in the event that the inclusion of women and mem19 bers of minority groups was not required.

20 ‘‘(C)(i) Clinical investigations designated by the Sec21 retary under clause (ii) which are submitted as part of

22 an application in accordance with paragraph (1) shall be

23 designed so that there is a valid analysis of whether the

24 device under investigation affects women or members of

25 minority groups differently than other users of the device.
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1 ‘‘(ii) The Secretary shall designate which of the clini2 cal investigations submitted as part of an application

3 under paragraph (1) shall be subject to the requirement

4 of clause (i).’’.

5 SEC. 5. BIOLOGICAL PRODUCTS CLINICAL INVESTIGA6 TIONS.

7 Section 351(c) of the Public Health Service Act (42

8 U.S.C. 262(c)) is amended by adding at the end the

9 following:

10 ‘‘(3)(A) Clinical investigations submitted as part of

11 an application in accordance with paragraph (1) shall in12 clude women and members of minority groups as subjects

13 of such investigations unless the inclusion of women and

14 minority groups is inappropriate with respect to the bio15 logical product under investigation or is otherwise inap16 propriate under such guidelines as the Secretary shall by

17 rule establish in accordance with subparagraph (B).

18 ‘‘(B) The guidelines of the Secretary respecting the

19 inclusion of women and members of minority groups in

20 clinical investigations—

21 ‘‘(i) shall provide that the costs of such inclu22 sion is not a permissible consideration in determin23 ing whether such inclusion is inappropriate,

24 ‘‘(ii) shall provide that women or minority

25 groups are not required to be included if women or
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1 minority groups will not be using the biological prod2 uct under investigation, and

3 ‘‘(iii) may provide that such inclusion is not re4 quired if there is substantial scientific data dem5 onstrating that there is no significant difference be6 tween the effects that the variables to be studied in

7 the investigation have on women or members of mi8 nority groups, respectively, and on the other individ9 uals who would serve as subjects in the investigation

10 in the event that the inclusion of women and mem11 bers of minority groups was not required.

12 ‘‘(C)(i) Clinical investigations designated by the Sec13 retary under clause (ii) which are submitted as part of

14 an application in accordance with paragraph (1) shall be

15 designed so that there is a valid analysis of whether the

16 device under investigation affects women or members of

17 minority groups differently than other users of the device.

18 ‘‘(ii) The Secretary shall designate which of the clini19 cal investigations submitted as part of an application

20 under paragraph (1) shall be subject to the requirement

21 of clause (i).’’.

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