I 

112TH CONGRESS 

1ST SESSION H. R. 3526 

To amend the Public Health Service Act to improve women’s health by 

prevention, diagnosis, and treatment of heart disease, stroke, and other 

cardiovascular diseases in women, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 30, 2011 

Mrs. CAPPS introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to improve women’s 

health by prevention, diagnosis, and treatment of heart 

disease, stroke, and other cardiovascular diseases in 

women, 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 ‘‘Heart Disease Edu5 cation, Analysis, Research, and Treatment for Women 

6 Act’’ or the ‘‘HEART for Women Act’’. 


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1 SEC. 2. REPORTING OF DATA IN APPLICATIONS FOR 

2 DRUGS, BIOLOGICS, AND DEVICES. 

3 (a) IN GENERAL.—The Comptroller General of the 

4 United States shall conduct a study investigating the ex5 tent to which sponsors of clinical studies of investigational 

6 drugs, biologics, and devices and sponsors of applications 

7 for approval or licensure of new drugs, biologics, and de8 vices comply with Food and Drug Administration require9 ments and follow guidance for presentation of clinical 

10 study safety and effectiveness data by sex, age, and racial 

11 subgroups. 

12 (b) REPORT BY GAO.— 

13 (1) SUBMISSION.—Not later than 12 months 

14 after the date of the enactment of this Act, the 

15 Comptroller General shall complete the study under 

16 subsection (a) and submit to the Committee on En17 ergy and Commerce of the House of Representatives 

18 and the Committee on Health, Education, Labor, 

19 and Pensions of the Senate a report on the results 

20 of such study. 

21 (2) CONTENTS.—The report required by para22 graph (1) shall include each of the following: 

23 (A) A description of the extent to which 

24 the Food and Drug Administration assists 

25 sponsors in complying with the requirements 


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1 and following the guidance referred to in sub2 section (a). 

3 (B) A description of the effectiveness of 

4 the Food and Drug Administration’s enforce5 ment of compliance with such requirements. 

6 (C) An analysis of the extent to which fe7 males, racial and ethnic minorities, and adults 

8 of all ages are adequately represented in Food 

9 and Drug Administration-approved clinical 

10 studies (at all phases) so that product safety 

11 and effectiveness data can be evaluated by gen12 der, age, and racial subgroup. 

13 (D) An analysis of the extent to which a 

14 summary of product safety and effectiveness 

15 data disaggregated by sex, age, and racial sub16 group is readily available to the public in a 

17 timely manner by means of the product label or 

18 the Food and Drug Administration’s Web site. 

19 (E) Appropriate recommendations for— 

20 (i) modifications to the requirements 

21 and guidance referred to in subsection (a); 

22 or 

23 (ii) oversight by the Food and Drug 

24 Administration of such requirements. 


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1 (c) REPORT BY HHS.—Not later than 6 months 

2 after the submission by the Comptroller General of the 

3 report required under subsection (b), the Secretary of 

4 Health and Human Services shall submit to the Com5 mittee on Energy and Commerce of the House of Rep6 resentatives and the Committee on Health, Education, 

7 Labor, and Pensions of the Senate a response to such re8 port, including a corrective action plan as needed to re9 spond to the recommendations in such report. 

10 (d) BIENNIAL REPORTS BY THE FOOD AND DRUG

11 ADMINISTRATION.—Not later than 2 years after the date 

12 of enactment of this Act, and every 2 years thereafter— 

13 (1) the Director of the Office of Women’s 

14 Health of the Food and Drug Administration shall 

15 submit to the Committee on Energy and Commerce 

16 of the House of Representatives and the Committee 

17 on Health, Education, Labor, and Pensions of the 

18 Senate, a report that includes each of the elements 

19 described in subparagraphs (A) through (E) of sub20 section (b)(2), with respect to women’s health; and 

21 (2) the Director of the Office of Minority 

22 Health of the Food and Drug Administration shall 

23 submit to such Committees a report that includes 

24 each of such elements, with respect to minority 

25 health. 


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1 (e) DEFINITIONS.—In this section: 

2 (1) The term ‘‘biologic’’ has the meaning given 

3 to the term ‘‘biological product’’ in section 351(i) of 

4 the Public Health Service Act (42 U.S.C. 262(i)). 

5 (2) The term ‘‘device’’ has the meaning given to 

6 such term in section 201(h) of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 321(h)). 

8 (3) The term ‘‘drug’’ has the meaning given to 

9 such term in section 201(g) of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 321(g)). 

11 SEC. 3. REPORTING ON QUALITY OF AND ACCESS TO CARE 

12 FOR WOMEN WITH CARDIOVASCULAR DIS13 EASES. 

14 Part P of title III of the Public Health Service Act 

15 (42 U.S.C. 280g et seq.) is amended by adding at the end 

16 the following: 

17 ‘‘SEC. 399V–6. REPORTING ON QUALITY OF AND ACCESS TO 

18 CARE FOR WOMEN WITH CARDIOVASCULAR 

19 DISEASES. 

20 ‘‘Not later than September 30, 2014, and annually 

21 thereafter, the Secretary of Health and Human Services 

22 shall prepare and submit to the Congress a report on the 

23 quality of and access to care for women with heart disease, 

24 stroke, and other cardiovascular diseases. The report shall 

25 contain recommendations for eliminating disparities in, 


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1 and improving the treatment of, heart disease, stroke, and 

2 other cardiovascular diseases in women.’’. 

3 SEC. 4. EXTENSION OF WISEWOMAN PROGRAM. 

4 Section 1509 of the Public Health Service Act (42 

5 U.S.C. 300n–4a) is amended— 

6 (1) in subsection (a)— 

7 (A) by striking the heading and inserting 

8 ‘‘IN GENERAL.—’’; and 

9 (B) in the matter preceding paragraph (1), 

10 by striking ‘‘may make grants’’ and all that fol11 lows through ‘‘purpose’’ and inserting the fol12 lowing: ‘‘may make grants to such States for 

13 the purpose’’; 

14 (2) in subsection (d)(1), by striking ‘‘there are 

15 authorized’’ and all that follows through the period 

16 and inserting ‘‘there are authorized to be appro17 priated $23,000,000 for fiscal year 2012, 

18 $25,300,000 for fiscal year 2013, $27,800,000 for 

19 fiscal year 2014, $30,800,000 for fiscal year 2015, 

20 and $34,000,000 for fiscal year 2016.’’; and 

21 (3) by adding at the end the following new sub22 section: 

23 ‘‘(e) STUDY.— 

24 ‘‘(1) The Secretary shall (directly or through 

25 grants or contracts) conduct a study of the impact 


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1 of the Patient Protection and Affordable Care Act 

2 on the preventive health services, referrals, and fol3 low-up services described in subsection (a). 

4 ‘‘(2) Not later than 18 months after the date 

5 of enactment of this subsection, the Secretary shall 

6 submit to the Committee on Energy and Commerce 

7 of the House of Representatives and to the Com8 mittee on Health, Education, Labor, and Pensions 

9 of the Senate a report containing the results of the 

10 study under paragraph (1) and recommendations for 

11 improving the provision of preventive health services, 

12 referrals, and follow-up services described in para13 graph (1) to women eligible for such services under 

14 grants funded under this section.’’. 

Æ 


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