II

104TH CONGRESS

1ST SESSION S. 427

To amend various Acts to establish offices of women’s health within certain

agencies, and for other purposes.

IN THE SENATE OF THE UNITED STATES

FEBRUARY 16 (legislative day JANUARY 30), 1995

Ms. SNOWE introduced the following bill; which was read twice and referred

to the Committee on Labor and Human Resources

A BILL

To amend various Acts to establish offices of women’s health

within certain agencies, 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’s Health Office

5 Act of 1995’’.

6 SEC. 2. PUBLIC HEALTH SERVICE OFFICE OF WOMEN’S

7 HEALTH.

8 Part A of title III of the Public Health Service Act

9 (42 U.S.C. 241 et seq.) is amended by adding at the end

10 the following section:
2

•S 427 IS

1 ‘‘PUBLIC HEALTH SERVICE OFFICE OF WOMEN’S HEALTH

2 ‘‘SEC. 310A. (a) ESTABLISHMENT OF OFFICE.—

3 There is established an Office of Women’s Health (here4 after referred to in this section as the ‘Office’) within the

5 Office of the Assistant Secretary for Health.

6 ‘‘(b) ASSISTANT SECRETARY.—There shall be in the

7 Department of Health and Human Services a Deputy As8 sistant Secretary for Women’s Health, who shall be the

9 head of the Office. The Secretary, acting through such

10 Deputy Assistant Secretary, shall carry out this section.

11 ‘‘(c) DUTIES.—The Secretary, acting through the Of12 fice, shall, with respect to the health concerns of women—

13 ‘‘(1) establish short-range and long-range goals

14 and objectives and coordinate all other activities

15 within the Department of Health and Human Serv16 ices that relate to disease prevention, health pro17 motion, service delivery, and research concerning

18 women;

19 ‘‘(2) advise the Assistant Secretary for Health

20 concerning scientific, legal, ethical, and policy issues

21 relating to women’s health;

22 ‘‘(3) monitor Public Health Service agency and

23 regional activities regarding women’s health, and

24 coordinate activities of such agency Offices of

25 Women’s Health;
3

•S 427 IS

1 ‘‘(4) establish a women’s health resource center

2 to facilitate the exchange of information regarding

3 matters relating to health information and health

4 promotion, preventive health services, and education

5 in the appropriate use of health care, to facilitate ac6 cess to such information, to assist in the analysis of

7 issues and problems relating to such matters, and to

8 provide technical assistance with respect to the ex9 change of such information (including facilitating

10 the development of materials for such technical as11 sistance); and

12 ‘‘(5) coordinate efforts to promote women’s

13 health programs and policies in the voluntary and

14 corporate sectors.

15 ‘‘(d) REPORTS.—Not later than January 31, 1996,

16 and January 31 of each second year thereafter, the Sec17 retary shall prepare and submit to the appropriate com18 mittees of Congress a report describing the activities car19 ried out under this section during the preceding 2 fiscal

20 years.

21 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the

22 purpose of carrying out this section, there are authorized

23 to be appropriated such sums as may be necessary for

24 each of the fiscal years 1996 through 1998.’’.
4

•S 427 IS

1 SEC. 3. CENTERS FOR DISEASE CONTROL AND PREVEN2 TION OFFICE OF WOMEN’S HEALTH.

3 Part A of title III of the Public Health Service Act

4 (42 U.S.C. 241 et seq.) (as amended by section 2) is fur5 ther amended by adding at the end the following section:

6 ‘‘CENTERS FOR DISEASE CONTROL AND PREVENTION

7 OFFICE OF WOMEN’S HEALTH

8 ‘‘SEC. 310B. (a) ESTABLISHMENT.—There is estab9 lished within the Office of the Director of the Centers for

10 Disease Control and Prevention an office to be known as

11 the Office of Women’s Health (hereafter referred to in this

12 section as the ‘Office’). The Office shall be headed by a

13 director who shall be appointed by the Director of the

14 Centers.

15 ‘‘(b) PURPOSE.—The Director of the Office shall—

16 ‘‘(1) determine the current level of the Centers

17 activity regarding women’s health conditions, across

18 age, biological, and sociocultural contexts, in all as19 pects of the Centers work, including prevention pro20 grams, public and professional education, services,

21 and treatment;

22 ‘‘(2) establish short-range and long-range goals

23 and objectives for women’s health and coordinate all

24 other activities within the Centers that relate to pre25 vention, research, education and training, service de26 livery, and policy development;
5

•S 427 IS

1 ‘‘(3) identify projects in women’s health that

2 should be conducted or supported by the National

3 Centers;

4 ‘‘(4) consult with health professionals, non-gov5 ernmental organizations, consumer organizations,

6 women’s health professionals, and other individuals

7 and groups, as appropriate, on the policy of the Cen8 ters with regard to women; and

9 ‘‘(5) coordinate agency activities on women’s

10 health with the Public Health Service Office of

11 Women’s Health established under section 310A.

12 ‘‘(c) COORDINATING COMMITTEE.—

13 ‘‘(1) ESTABLISHMENT.—In carrying out sub14 section (b), the Director of the Office shall establish

15 a committee to be known as the Coordinating Com16 mittee on Research on Women’s Health (hereafter

17 referred to in this subsection as the ‘Coordinating

18 Committee’).

19 ‘‘(2) COMPOSITION.—The Coordinating Com20 mittee shall be composed of the Directors of the

21 National Centers.

22 ‘‘(3) CHAIRPERSON.—The Director of the Of23 fice shall serve as the chairperson of the Coordinat24 ing Committee.
6

•S 427 IS

1 ‘‘(4) DUTIES.—With respect to women’s health,

2 the Coordinating Committee shall assist the Director

3 of the Office in—

4 ‘‘(A) identifying the need for programs and

5 activities that focus on women’s health;

6 ‘‘(B) identifying needs regarding the co7 ordination of activities, including intramural

8 and extramural multidisciplinary activities; and

9 ‘‘(C) making recommendations to the Di10 rector of the Centers for Disease Control and

11 Prevention concerning findings made under

12 subparagraphs (A) and (B).

13 ‘‘(d) REPORTS.—Not later than January 31, 1996,

14 and January 31 of each second year thereafter, the Direc15 tor shall prepare and submit to the Director of the Public

16 Health Service Office of Women’s Health, a report de17 scribing the activities carried out under this section during

18 the preceding 2 fiscal years.

19 ‘‘(e) DEFINITION.—As used in this section the term

20 ‘women’s health conditions’, with respect to women of all

21 age, ethnic, and racial groups, means all diseases, dis22 orders, and conditions—

23 ‘‘(1) unique to, more serious, or more prevalent

24 in women; and
7

•S 427 IS

1 ‘‘(2) for which the factors of medical risk or

2 type of medical intervention are different for women,

3 or for which it is unknown whether such factors or

4 types are different for women.’’.

5 SEC. 4. AGENCY FOR HEALTH CARE POLICY AND RE6 SEARCH OFFICE OF WOMEN’S HEALTH.

7 Part C of title IX of the Public Health Service Act

8 (42 U.S.C. 299c et seq.) is amended—

9 (1) by redesignating section 927 as section 928;

10 and

11 (2) by inserting after section 926 the following

12 section:

13 ‘‘SEC. 927. OFFICE OF WOMEN’S HEALTH.

14 ‘‘(a) ESTABLISHMENT.—There is established within

15 the Office of the Director of the Agency for Health Care

16 Policy and Research an office to be known as the Office

17 of Women’s Health (hereafter referred to in this section

18 as the ‘Office’). The Office shall be headed by a Director

19 who shall be appointed by the Director of the Agency.

20 ‘‘(b) PURPOSE.—The Director of the Office shall—

21 ‘‘(1) determine the current Agency level of ac22 tivity regarding women’s health, across age, biologi23 cal, and sociocultural contexts, in all aspects of

24 Agency work, including drafting clinical practice

25 guidelines, and conducting research into patient out-
8

•S 427 IS

1 comes, delivery of health care services, and access to

2 health care;

3 ‘‘(2) establish short-range and long-range goals

4 and objectives for research important to women’s

5 health and coordinate all other activities within the

6 Agency that relate to health services and medical

7 effectiveness research;

8 ‘‘(3) identify projects in women’s health that

9 should be conducted or supported by the Agency;

10 ‘‘(4) consult with health professionals, non-gov11 ernmental organizations, consumer organizations,

12 women’s health professionals, and other individuals

13 and groups, as appropriate, on Agency policy with

14 regard to women; and

15 ‘‘(5) coordinate agency activities on women’s

16 health with the Public Health Service Office of

17 Women’s Health established under section 310A.

18 ‘‘(c) COORDINATING COMMITTEE.—

19 ‘‘(1) ESTABLISHMENT.—In carrying out sub20 section (b), the Director of the Office shall establish

21 a committee to be known as the Coordinating Com22 mittee on Research on Women’s Health (hereafter

23 referred to in this subsection as the ‘Coordinating

24 Committee’).
9

•S 427 IS

1 ‘‘(2) COMPOSITION.—The Coordinating Com2 mittee shall be composed of the Directors of the

3 Offices.

4 ‘‘(3) CHAIRPERSON.—The Director of the Of5 fice shall serve as the chairperson of the Coordinat6 ing Committee.

7 ‘‘(4) DUTIES.—With respect to research on

8 women’s health, the Coordinating Committee shall

9 assist the Director of the Office in—

10 ‘‘(A) identifying the need for such re11 search, and making an estimate each fiscal year

12 of the funds needed to adequately support the

13 research;

14 ‘‘(B) identifying needs regarding the co15 ordination of research activities, including in16 tramural and extramural multidisciplinary ac17 tivities; and

18 ‘‘(C) making recommendations to the Di19 rector of the Agency for Health Care Policy and

20 Research concerning findings made under sub21 paragraphs (A) and (B).

22 ‘‘(d) REPORTS.—Not later than January 31, 1996,

23 and January 31 of each second year thereafter, the Direc24 tor shall prepare and submit to the Director of the Public

25 Health Service Office of Women’s Health, a report de-
10

•S 427 IS

1 scribing the activities carried out under this section during

2 the preceding 2 fiscal years.’’.

3 SEC. 5. HEALTH RESOURCES AND SERVICES ADMINISTRA4 TION OFFICE OF WOMEN’S HEALTH.

5 Title VII of the Social Security Act (42 U.S.C. 901

6 et seq.) is amended by adding at the end the following

7 section:

8 ‘‘OFFICE OF WOMEN’S HEALTH

9 ‘‘SEC. 712. (a) ESTABLISHMENT.—There is estab10 lished within the Office of the Administrator of the Health

11 Resources and Services Administration an office to be

12 known as the Office of Women’s Health (hereafter re13 ferred to in this section as the ‘Office’). The Office shall

14 be headed by a director who shall be appointed by the Di15 rector of the Administration.

16 ‘‘(b) PURPOSE.—The Director of the Office shall—

17 ‘‘(1) determine the current agency level of activ18 ity regarding women’s health across age, biological,

19 and sociocultural contexts;

20 ‘‘(2) establish short-range and long-range goals

21 and objectives for women’s health and coordinate all

22 other activities within the agency that relate to

23 health care provider training, health service delivery,

24 research, and demonstration projects;

25 ‘‘(3) identify projects in women’s health that

26 should be conducted or supported by the Bureaus;
11

•S 427 IS

1 ‘‘(4) consult with health professionals, non-gov2 ernmental organizations, consumer organizations,

3 women’s health professionals, and other individuals

4 and groups, as appropriate, on agency policy with

5 regard to women; and

6 ‘‘(5) coordinate agency activities on women’s

7 health with the Public Health Service Office of

8 Women’s Health established under section 310A of

9 the Public Health Service Act.

10 ‘‘(c) COORDINATING COMMITTEE.—

11 ‘‘(1) ESTABLISHMENT.—In carrying out sub12 section (b), the Director of the Office shall establish

13 a committee to be known as the Coordinating Com14 mittee on Research on Women’s Health (hereafter

15 referred to in this subsection as the ‘Coordinating

16 Committee’).

17 ‘‘(2) COMPOSITION.—The Coordinating Com18 mittee shall be composed of the Directors of the

19 Bureaus.

20 ‘‘(3) CHAIRPERSON.—The Director of the Of21 fice shall serve as the Chairperson of the Coordinat22 ing Committee.

23 ‘‘(4) DUTIES.—With respect to research on

24 women’s health, the Coordinating Committee shall

25 assist the Director of the Office in—
12

•S 427 IS

1 ‘‘(A) identifying the need for programs and

2 activities that focus on women’s health;

3 ‘‘(B) identifying needs regarding the co4 ordination of activities, including intramural

5 and extramural multidisciplinary activities; and

6 ‘‘(C) making recommendations to the Di7 rector of the Centers for Disease Control and

8 Prevention concerning findings made under

9 subparagraphs (A) and (B).

10 ‘‘(d) REPORTS.—Not later than January 31, 1996,

11 and January 31 of each second year thereafter, the Direc12 tor of the Office shall prepare and submit to the Director

13 of the Public Health Service Office of Women’s Health,

14 a report describing the activities carried out under this

15 section during the preceding 2 fiscal years.’’.

16 SEC. 6. FOOD AND DRUG ADMINISTRATION OFFICE OF

17 WOMEN’S HEALTH.

18 Chapter IX of the Federal Food, Drug, and Cosmetic

19 Act (21 U.S.C. 391 et seq.) is amended by adding at the

20 end the following section:

21 ‘‘SEC. 906. OFFICE OF WOMEN’S HEALTH.

22 ‘‘(a) ESTABLISHMENT.—There is established within

23 the Office of the Commissioner of the Food and Drug Ad24 ministration an office to be known as the Office of Wom25 en’s Health (hereafter referred to in this section as the
13

•S 427 IS

1 ‘Office’). The Office shall be headed by a Director who

2 shall be appointed by the Commissioner of the Administra3 tion.

4 ‘‘(b) PURPOSE.—The Director of the Office shall—

5 ‘‘(1) determine current Commission levels of ac6 tivity regarding women’s participation in clinical

7 trials the study of gender differences in the testing

8 of drugs, medical devices, and biological products,

9 across, age, sociocultural, and, where deemed appro10 priate, biological contexts;

11 ‘‘(2) establish short-range and long-range goals

12 and objectives for adequate inclusion of women in all

13 Commission protocols and policies;

14 ‘‘(3) provide guidance or criteria for drug and

15 device manufacturers to use in determining the ex16 tent and sufficiency of female representation in clini17 cal trials;

18 ‘‘(4) consult with pharmaceutical manufactur19 ers, health professionals with expertise in women’s

20 issues, consumer organizations, and women’s health

21 professionals on Commission policy with regard to

22 women;

23 ‘‘(5) make annual estimates of funds needed to

24 monitor clinical trials in accordance with needs that

25 are identified; and
14

•S 427 IS

1 ‘‘(6) coordinate Commission activities on wom2 en’s health with the Public Health Service Office of

3 Women’s Health established under section 310A of

4 the Public Health Service Act.

5 ‘‘(c) COORDINATING COMMITTEE.—

6 ‘‘(1) ESTABLISHMENT.—In carrying out sub7 section (b), the Director of the Office shall establish

8 a committee to be known as the Coordinating Com9 mittee on Women’s Health (hereafter referred to in

10 this subsection as the ‘Coordinating Committee’).

11 ‘‘(2) COMPOSITION.—The Coordinating Com12 mittee shall be composed of the Directors of the

13 Food and Drug Administration Centers.

14 ‘‘(3) CHAIRPERSON.—The Director of the Of15 fice shall serve as the Chairperson of the Coordinat16 ing Committee.

17 ‘‘(4) DUTIES.—With respect to studies on wom18 en’s health, the Coordinating Committee shall assist

19 the Director of the Office in—

20 ‘‘(A) identifying the need for further stud21 ies in specific areas of women’s health that fall

22 within the mission of the Commission, and de23 veloping strategies to foster such studies;
15

•S 427 IS

1 ‘‘(B) identifying needs regarding the co2 ordination of Commission activities, including

3 intramural and extramural studies;

4 ‘‘(C) maintaining the Commission’s focus

5 in areas of importance to women;

6 ‘‘(D) supporting the development of meth7 odologies to determine the circumstances in

8 which obtaining data specific to women (includ9 ing data relating to the age of women and the

10 membership of women in ethnic or racial

11 groups) is an appropriate function of clinical

12 trials of treatments and therapies;

13 ‘‘(E) supporting the development and ex14 pansion of clinical trials of treatments and

15 therapies for which obtaining such data has

16 been determined to be an appropriate function;

17 and

18 ‘‘(F) encouraging the Food and Drug Ad19 ministration Centers to conduct and support

20 such studies, including such clinical trials.

21 ‘‘(d) REPORTS.—Not later than January 31, 1996,

22 and January 31 of each second year thereafter, the Direc23 tor shall prepare and submit to the Director of the Public

24 Health Service Office of Women’s Health, a report de-
16

•S 427 IS

1 scribing the activities carried out under this section during

2 the preceding 2 fiscal years.’’.

Æ