I

103D CONGRESS

1ST SESSION H. R. 2394

To amend the Public Health Service Act to establish programs of research

with respect to women and cases of infection with the human

immunodeficiency virus.

IN THE HOUSE OF REPRESENTATIVES

JUNE 10, 1993

Mrs. MORELLA (for herself, Mr. BIELENSON, Mr. FRANK of Massachusetts,

Mr. FROST, Mr. GIBBONS, Mr. GILMAN, Mr. JEFFERSON, Ms. EDDIE

BERNICE JOHNSON of Texas, Mr. MATSUI, Mr. MCDERMOTT, Mrs.

MEEK, Mr. MILLER of California, Mrs. MINK, Ms. MOLINARI, Ms. NORTON, Mr. PAYNE of New Jersey, Mr. SANDERS, Mrs. SCHROEDER, Ms.

SNOWE, Mr. STUDDS, Mr. TOWNS, Mrs. UNSOELD, Ms. WATERS, Mr.

WHEAT, Mr. WYDEN, and Mr. YATES) introduced the following bill;

which was referred to the Committee on Energy and Commerce

A BILL

To amend the Public Health Service Act to establish programs of research with respect to women and cases of

infection with the human immunodeficiency virus.

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 ‘‘Women and AIDS Re5 search Initiative Amendments of 1993’’.
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1 SEC. 2. ESTABLISHMENT OF GENERAL PROGRAM OF RE2 SEARCH REGARDING WOMEN AND ACQUIRED

3 IMMUNE DEFICIENCY SYNDROME.

4 Part B of title XXIII of the Public Health Service

5 Act (42 U.S.C. 300cc–11 et seq.) is amended by adding

6 at the end the following section:

7 ‘‘SEC. 2321. RESEARCH REGARDING WOMEN.

8 ‘‘(a) IN GENERAL.—With respect to cases of infec9 tion with the human immunodeficiency virus, the Sec10 retary shall establish a program for the purpose of con11 ducting biomedical and behavioral research on such cases

12 in women, including research on the prevention of such

13 cases. The Secretary may conduct such research directly,

14 and may make grants to public and nonprofit private enti15 ties for the conduct of the research.

16 ‘‘(b) CERTAIN FORMS OF RESEARCH.—In carrying

17 out subsection (a), the Secretary shall provide for research

18 on—

19 ‘‘(1) the manner in which the human

20 immunodeficiency virus is transmitted to women, in21 cluding the relationship between cases of infection

22 with such virus and other cases of sexually transmit23 ted diseases, including clinical trials which examine

24 the question of how much human immunodeficiency

25 virus infection can be prevented by finding and

26 treating sexually transmitted diseases in women;
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1 ‘‘(2) measures for the prevention of exposure to

2 and the transmission of such virus, including re3 search on—

4 ‘‘(A) the prevention of any sexually trans5 mitted disease that may facilitate the trans6 mission of the virus;

7 ‘‘(B) rapid, inexpensive, easy-to-use sexu8 ally transmitted disease diagnostic tests for

9 women;

10 ‘‘(C) inexpensive single dose therapy for

11 treatable sexually transmitted diseases;

12 ‘‘(D) the development of methods of pre13 vention for use by women; and

14 ‘‘(E) the development and dissemination of

15 prevention programs and materials whose pur16 pose is to reduce the incidence of substance

17 abuse among women;

18 ‘‘(3) the development and progression of symp19 toms resulting from infection with such virus, in20 cluding research regarding gynecological infections

21 as well as breast changes, hormonal changes, and

22 menses and menopause changes, whose occurrence

23 becomes probable as a result of the deterioration of

24 the immune system;
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1 ‘‘(4) the treatment of cases of such infection,

2 including clinical research; and

3 ‘‘(5) behavioral research on the prevention of

4 such cases and research on model educational pro5 grams for such prevention.

6 ‘‘(c) CLINICAL TRIALS.—

7 ‘‘(1) GYNECOLOGICAL EVALUATIONS.—In clini8 cal trials regarding the human immunodeficiency

9 virus in which women participate as subjects, the

10 Secretary shall ensure that—

11 ‘‘(A) each female subject who is infected

12 with the human immunodeficiency virus—

13 ‘‘(i) undergoes a gynecological exam14 ination as part of the evaluation of the

15 medical status of the woman prior to par16 ticipation in the trial; and

17 ‘‘(ii) receives appropriate follow-up

18 services regarding such examination; and

19 ‘‘(B) the results of the gynecological ex20 aminations are analyzed to determine the rela21 tionship between gynecological conditions and

22 the infection with such virus.

23 ‘‘(2) STANDARD TREATMENTS FOR GYNECO24 LOGICAL CONDITIONS.—The Secretary shall conduct

25 or support clinical trials under subsection (a) to de-
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1 termine whether standard methods of treating gyne2 cological conditions are effective in the case of such

3 conditions that arise as a result of infection with the

4 human immunodeficiency virus.

5 ‘‘(3) EFFECTIVENESS OF CERTAIN TREATMENT

6 PROTOCOLS.—With respect to cases of infection with

7 the human immunodeficiency virus, the Secretary

8 shall conduct or support clinical trials under sub9 section (a) to determine whether treatment protocols

10 approved for men with such cases are effective for

11 women with such cases.

12 ‘‘(4) SUPPORT SERVICES.—

13 ‘‘(A) In conducting or supporting clinical

14 trials regarding the human immunodeficiency

15 virus in which women participate as subjects,

16 the Secretary shall provide the women with

17 such transportation, child care, and other sup18 port services (including medical and mental

19 health services, treatment for drug abuse, and

20 social services, including services addressing do21 mestic violence) as may be necessary to enable

22 the women to participate as such subjects.

23 ‘‘(B) Services under subparagraph (A)

24 shall include services designed to respond to the

25 particular needs of women with respect to par-
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1 ticipation in the clinical trials involved, includ2 ing, as appropriate, training of the individuals

3 who conduct the trials.

4 ‘‘(d) PREVENTION PROGRAMS.—

5 ‘‘(1) SEXUAL TRANSMISSION.—

6 ‘‘(A) With respect to preventing the sexual

7 transmission of the human immunodeficiency

8 virus, the Secretary shall conduct or support re9 search under subsection (a) on barrier methods

10 for prevention of sexually transmitted diseases,

11 including human immunodeficiency virus dis12 ease, that women can use without their sexual

13 partner’s cooperation or knowledge.

14 ‘‘(B) In carrying out subparagraph (A),

15 the Secretary shall give priority to identified re16 search needs and opportunities identified at the

17 National Institutes of Health sponsored meet18 ing on Development of Topical Microbicides

19 held in May 1993, including research on—

20 ‘‘(i) the early steps in infectious proc21 esses;

22 ‘‘(ii) identification, formulation, and

23 preclinical evaluation of new preparations;

24 ‘‘(iii) clinical testing for safety and ef25 ficacy; and
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1 ‘‘(iv) studies on acceptability and com2 pliance of safe, effective microbicides.

3 ‘‘(2) EPIDEMIOLOGICAL RESEARCH.—The Sec4 retary shall conduct or support epidemiological re5 search under subsection (a) to determine the factors

6 of risk regarding infection with the human

7 immunodeficiency virus that are particular to

8 women, including research regarding—

9 ‘‘(A) the use of various contraceptive meth10 ods;

11 ‘‘(B) the use of tampons;

12 ‘‘(C) the relationship between such infec13 tion and other sexually transmitted diseases;

14 ‘‘(D) the relationship between such infec15 tion and various forms of substance abuse (in16 cluding use of the form of cocaine commonly

17 known as crack); and

18 ‘‘(E) the relationship between such infec19 tion and noncoital forms of sexual activity.

20 ‘‘(e) INTERAGENCY STUDY.—With respect to the

21 study (known as the Women’s Interagency HIV Study)

22 that, as of June 1993, is being carried out by the Sec23 retary through various agencies of the Public Health Serv24 ice for the purpose of monitoring the progression in

25 women of infection with the human immunodeficiency
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1 virus, and determining whether such progression is dif2 ferent in women than in men, the following applies:

3 ‘‘(1) The Secretary shall ensure that not less

4 than 5,000 women with such infection are included

5 in the study.

6 ‘‘(2) The Secretary shall provide for an increase

7 in the number of sites at which the study is to be

8 conducted.

9 ‘‘(3) The Secretary shall ensure that the study

10 period is for a minimum of 8 years.

11 ‘‘(4) With respect to markers of human

12 immunodeficiency virus disease progression and viral

13 activity, including the cells commonly known as CD4

14 cells, the Secretary shall ensure that the study ade15 quately addresses the relationship between such

16 markers and the development of serious illnesses in

17 such women, including the relationship between the

18 number of such cells and the development of such

19 illnesses. For purposes of the preceding sentence,

20 the study shall address gynecological conditions, and

21 other conditions particular to women, that are not

22 currently included in the list of conditions arising

23 from such infection that, for surveillance purposes,

24 is maintained by the Director of the Centers for Dis25 ease Control and Prevention.
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1 ‘‘(f) DEFINITIONS.—For purposes of this section, the

2 term ‘human immunodeficiency virus’ means the etiologic

3 agent for acquired immune deficiency syndrome.

4 ‘‘(g) AUTHORIZATIONS OF APPROPRIATIONS.—

5 ‘‘(1) CLINICAL TRIALS.—

6 ‘‘(A) For the purpose of carrying out sub7 section (c)(1), there are authorized to be appro8 priated $20,000,000 for fiscal year 1994, and

9 such sums as may be necessary for each of the

10 fiscal years 1995 through 1996.

11 ‘‘(B) For the purpose of carrying out sub12 section (c)(2), there are authorized to be appro13 priated $10,000,000 for fiscal year 1994, and

14 such sums as may be necessary for each of the

15 fiscal years 1995 through 1996.

16 ‘‘(C) For the purpose of carrying out sub17 section (c)(3), there are authorized to be appro18 priated $10,000,000 for fiscal year 1994, and

19 such sums as may be necessary for each of the

20 fiscal years 1995 through 1996.

21 ‘‘(D) For the purpose of carrying out sub22 section (c)(4), there are authorized to be appro23 priated $15,000,000 for fiscal year 1994, and

24 such sums as may be necessary for each of the

25 fiscal years 1995 and 1996.
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1 ‘‘(2) PREVENTION PROGRAMS.—

2 ‘‘(A) For the purpose of carrying out sub3 section (d)(1), there are authorized to be appro4 priated $30,000,000 for fiscal year 1994, and

5 such sums as may be necessary for each of the

6 fiscal years 1995 through 1996.

7 ‘‘(B) For the purpose of carrying out sub8 section (d)(2), there are authorized to be appro9 priated $10,000,000 for fiscal year 1994, and

10 such sums as may be necessary for each of the

11 fiscal years 1995 through 1996.

12 ‘‘(3) INTERAGENCY STUDY.—For the purpose

13 of carrying out subsection (e), there are authorized

14 to be appropriated $15,000,000 for fiscal year 1994,

15 and such sums as may be necessary for each of the

16 fiscal years 1995 through 1996.’’.

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