II

103D CONGRESS

1ST SESSION S. 1429

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

with respect to women and cases of information with the human

immunodeficiency virus, and for other purposes.

IN THE SENATE OF THE UNITED STATES

AUGUST 6 (legislative day, JUNE 30), 1993

Mr. SIMON (for himself, Mrs. MURRAY, Mr. RIEGLE, Ms. MOSELEY-BRAUN,

and Mrs. BOXER) introduced the following bill; which was read twice and

referred to the Committee on Labor and Human Resources

A BILL

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

information with the human immunodeficiency virus, and

for other purposes.

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

5 Research 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 XXII of the Public Health Service Act

5 (42 U.S.C. 800cc–11 et seq.) is amended by adding at

6 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, and clinical trials which examine the

24 question of the how the level of HIV infection can

25 be prevented by finding and treating sexually trans26 mitted 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 under this title in which women participate

9 as subjects, the Secretary shall ensure that—

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

11 with the human immunodeficiency virus—

12 ‘‘(i) undergoes a gynecological exam13 ination as part of the evaluation of the

14 medical status of the woman prior to par15 ticipation in the trial; and

16 ‘‘(ii) receives appropriate follow-up

17 services regarding such examination; and

18 ‘‘(B) the results of the gynecological ex19 aminations are analyzed to determine the rela20 tionship between gynecological conditions and

21 the infection with such virus.

22 ‘‘(2) STANDARD TREATMENTS FOR GYNECO23 LOGICAL CONDITIONS.—The Secretary shall conduct

24 or support clinical trials under subsection (a) to de25 termine whether standard methods of treating gyne-
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1 cological conditions are effective in the case of such

2 conditions that arise as a result of infection with the

3 human immunodeficiency virus.

4 ‘‘(3) EFFECTIVENESS OF CERTAIN TREATMENT

5 PROTOCOLS.—With respect to cases of infection with

6 the human immunodeficiency virus, the Secretary

7 shall conduct or support clinical trials under sub8 section (a) to determine whether treatment protocols

9 approved for men with such cases are effective for

10 women with such cases.

11 ‘‘(4) SUPPORT SERVICES.—

12 ‘‘(A) In conducting or supporting clinical

13 trials under this title in which women partici14 pate as subjects, the Secretary shall provide the

15 women with such transportation, child care, and

16 other support services (including medical and

17 mental health services, treatment for drug

18 abuse, and social services), including services

19 addressing domestic violence as may be nec20 essary to enable the women to participate as

21 such subjects.

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

23 shall include services designed to respond to the

24 particular needs of women with respect to par25 ticipation in clinical trials under this title, in-
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1 cluding, as appropriate, training of the individ2 uals who conduct the trials.

3 ‘‘(d) PREVENTION PROGRAMS.—

4 ‘‘(1) SEXUAL TRANSMISSION.—

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

6 transmission of the human immunodeficiency

7 virus, the Secretary shall conduct or support re8 search under subsection (a) on barrier methods

9 for the prevention of sexually transmitted dis10 eases, including HIV disease, that women can

11 use without their sexual partner’s cooperation

12 or knowledge.

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

14 the Secretary shall give priority to identified re15 search needs and opportunities identified at the

16 National Institutes of Health sponsored meet17 ing on Development of Topical Microbicides

18 that was held in May of 1993, including re19 search on—

20 ‘‘(i) the early stages in infectious

21 processes;

22 ‘‘(ii) the identification, formulation

23 and preclinical evaluation of new prepara24 tions;
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1 ‘‘(iii) clinical testing for safety and ef2 ficacy; and

3 ‘‘(iv) studies concerning the accept4 ability and compliance of safe, effective

5 microbicides.

6 ‘‘(2) EPIDEMIOLOGICAL RESEARCH.—The Sec7 retary shall conduct or support epidemiological re8 search under subsection (a) to determine the factors

9 of risk regarding infection with the human

10 immunodeficiency virus that are particular to

11 women, including research regarding—

12 ‘‘(A) the use of various contraceptive

13 methods;

14 ‘‘(B) the use of tampons;

15 ‘‘(C) the relationship between such infec16 tion and other sexually transmitted diseases;

17 ‘‘(D) the relationship between such infec18 tion and various forms of substance abuse (in19 cluding use of the form of cocaine commonly

20 known as crack); and

21 ‘‘(E) the relationship between such infec22 tion and sexual activity.

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

24 study being carried out by the Secretary (as of June 1993)

25 through various agencies of the Public Health Service for
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1 the purpose of monitoring the progression in women of

2 infection with the human immunodeficiency virus, and de3 termining whether such progression is different in women

4 than in men, which study is known as the Women’s Inter5 agency HIV Study, the following applies:

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

7 than 5,000 women with such infection are included

8 in the study.

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

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

11 conducted.

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

13 period is for a minimum of 8 years.

14 ‘‘(4) With respect to the human cells commonly

15 known as CD4 cells, the Secretary shall ensure that

16 the study adequately addresses the relationship be17 tween the number of such cells and other markers

18 in women with such infection and the development

19 of serious illnesses in such women. For purposes of

20 the preceding sentence, the study shall address gyne21 cological conditions, and other conditions particular

22 to women, that are not currently included in the list

23 of conditions arising from such infection that, for

24 surveillance purposes, is maintained by the Director

25 of the Centers for Disease Control and Prevention.
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1 ‘‘(f) DEFINITION.—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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