II 

109TH CONGRESS 

2D SESSION S. 2278 

To amend the Public Health Service Act to improve the prevention, diagnosis, 

and treatment of heart disease, stroke, and other cardiovascular diseases 

in women. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 14, 2006 

Ms. STABENOW (for herself and Ms. MURKOWSKI) introduced the following 

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Public Health Service Act to improve the 

prevention, diagnosis, and treatment of heart disease, 

stroke, and other cardiovascular diseases in women. 

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, and Research, and Treatment for Women 

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

7 SEC. 2. FINDINGS. 

8 Congress makes the following findings: 
2 

•S 2278 IS

1 (1) Heart disease, stroke, and other cardio2 vascular diseases are the leading cause of death 

3 among women. 

4 (2) Despite being the number 1 killer, only 13 

5 percent of women are aware that cardiovascular dis6 eases, including heart disease and stroke, are their 

7 greatest health risk. 

8 (3) Many minority women, including African 

9 American, Hispanic, and Native American women, 

10 are at a higher risk of death from heart disease, 

11 stroke, and other cardiovascular diseases, but they 

12 are less likely to know of this risk. 

13 (4) There is a pervasive lack of awareness 

14 among health care providers that cardiovascular dis15 ease is the leading killer of women. 

16 (5) Women are less likely than men to receive 

17 certain treatments for cardiovascular diseases, per18 haps due to lack of awareness and the presence of 

19 different symptoms in women than in men. 

20 (6) Women tend to experience later onset of 

21 heart disease than men, and therefore more often 

22 suffer from multiple conditions that mask symptoms 

23 of heart disease and complicate treatment. 

24 (7) Certain diagnostic tests for cardiovascular 

25 disease may be less accurate in women than men. 
3 

•S 2278 IS

1 (8) Drug effectiveness and metabolism differ in 

2 women and men, impacting successful treatment of 

3 cardiovascular disease. 

4 (9) In addition, stroke kills 2.3 times as many 

5 females as does breast cancer. Nearly 61 percent of 

6 stroke-related deaths occur in females. Studies have 

7 found gender differences in the effects, diagnosis, 

8 and treatment of stroke. For instance— 

9 (A) stroke severity is greater in women 

10 than in men; 

11 (B) women often receive fewer diagnostic 

12 tests and intervention procedures than men; 

13 and 

14 (C) strokes present treatment issues 

15 unique to women. 

16 SEC. 3. REPORTING OF GENDER DATA IN APPLICATIONS 

17 FOR DRUGS, BIOLOGICS, AND DEVICES. 

18 (a) NEW DRUG APPLICATIONS.—Section 505(b) of 

19 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

20 355(b)) is amended by adding at the end the following: 

21 ‘‘(5)(A) Notwithstanding any other provision of this 

22 Act, the applicant shall include in any submission to the 

23 Secretary pursuant to this subsection, to the extent appro24 priate, information stratified by gender, race and eth-
4 

•S 2278 IS

1 nicity, including any differences in safety and effective2 ness. 

3 ‘‘(B) The Secretary shall withhold approval of an ap4 plication if the applicant fails to submit the required infor5 mation described in subparagraph (A). 

6 ‘‘(C) The Secretary shall develop standards to ensure 

7 that submissions to the Secretary pursuant to this sub8 section are adequately reviewed to determine whether such 

9 submissions include the information required under sub10 paragraph (A). 

11 ‘‘(D) Upon the approval under this subsection of an 

12 application for a drug, the Secretary shall report to the 

13 scientific community and make available to the public, in 

14 a timely manner, data regarding such drug stratified by 

15 gender, race, and ethnicity.’’. 

16 (b) INVESTIGATIONAL NEW DRUG APPLICATIONS.— 

17 Section 505(i) of the Federal Food, Drug, and Cosmetic 

18 Act (21 U.S.C. 355(i)) is amended— 

19 (1) in paragraph (2), by inserting ‘‘and para20 graph (5)’’ after ‘‘Subject to paragraph (3)’’; and 

21 (2) by adding at the end the following: 

22 ‘‘(5)(A) Notwithstanding any other provision of this 

23 Act, the manufacturer or sponsor of an investigation of 

24 a new drug shall include in any submission to the Sec25 retary pursuant to this subsection on the clinical investiga-
5 

•S 2278 IS

1 tion of the new drug and to the extent appropriate, infor2 mation stratified by gender, race, and ethnicity, including 

3 any differences in safety and effectiveness. 

4 ‘‘(B) The Secretary shall place a clinical hold (as de5 scribed in paragraph (3)) on an investigation if the manu6 facturer or sponsor of the investigation fails to submit the 

7 required information described in subparagraph (A). 

8 ‘‘(C) The Secretary shall develop standards that en9 sure that submissions to the Secretary pursuant to this 

10 subsection on clinical investigations of new drugs are ade11 quately reviewed to determine whether such submissions 

12 include the information required under this paragraph.’’. 

13 (c) ABBREVIATED NEW DRUG APPLICATIONS.—Sec14 tion 505(j) of the Federal Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 355(j)) is amended— 

16 (1) in paragraph (2)(A), by inserting before the 

17 period at the end the following: ‘‘, subject to para18 graph (10)’’; 

19 (2) in paragraph (3)(A), by adding at the end 

20 the following: ‘‘The Secretary shall require such in21 dividuals who review such applications to ensure 

22 that such applications include the information on 

23 gender data required under paragraph (10).’’; 

24 (3) in paragraph (4)— 
6 

•S 2278 IS

1 (A) in subparagraph (J), by striking ‘‘or’’ 

2 after the semicolon; 

3 (B) in subparagraph (K), by striking the 

4 period at the end and inserting ‘‘; or’’; and 

5 (C) by adding at the end the following: 

6 ‘‘(L) the application does not include ap7 propriate information stratified by gender, race, 

8 and ethnicity, as required under paragraph 

9 (10).’’; and 

10 (4) by adding at the end the following: 

11 ‘‘(10)(A) Notwithstanding any other provision of this 

12 Act, a person shall include in any submission to the Sec13 retary pursuant to this subsection appropriate drug infor14 mation stratified by gender, race, and ethnicity, including 

15 any differences in safety and effectiveness. 

16 ‘‘(B) The Secretary shall develop standards that en17 sure that submissions to the Secretary pursuant to this 

18 subsection are adequately reviewed to determine whether 

19 such submissions include the information required under 

20 this paragraph. 

21 ‘‘(11) Upon the approval under this subsection of an 

22 application for a drug, the Secretary shall report to the 

23 scientific community and make available to the public, in 

24 a timely manner, data regarding such drug stratified by 

25 gender, race, and ethnicity.’’. 
7 

•S 2278 IS

1 (d) PREMARKET APPROVALS.—Section 515 of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) 

3 is amended— 

4 (1) in subsection (c)— 

5 (A) in paragraph (1)— 

6 (i) in subparagraph (F), by striking 

7 ‘‘and’’ at the end; 

8 (ii) in subparagraph (G), by striking 

9 the period and inserting ‘‘; and’’; and 

10 (iii) by adding at the end the fol11 lowing: 

12 ‘‘(H) information regarding the device, to the 

13 extent appropriate, stratified by gender, race and 

14 ethnicity, including differences in safety and effec15 tiveness.’’; and 

16 (B) by adding at the end the following: 

17 ‘‘(5) The Secretary shall develop standards that en18 sure that submissions to the Secretary pursuant to this 

19 subsection are adequately reviewed to determine whether 

20 such submissions include the information required under 

21 paragraph (1)(H).’’; and 

22 (2) in subsection (d)— 

23 (A) in paragraph (1)— 

24 (i) in subparagraph (D), by striking 

25 ‘‘or’’ at the end; 
8 

•S 2278 IS

1 (ii) in subparagraph (E), by striking 

2 the period and inserting ‘‘; or’’; and 

3 (iii) by inserting after subparagraph 

4 (E), the following: 

5 ‘‘(F) the application does not contain, as appro6 priate, the information required in subsection 

7 (c)(1)(H).’’; and 

8 (B) by adding at the end the following: 

9 ‘‘(7) Upon the approval of an application under this 

10 section, the Secretary shall report to the scientific commu11 nity and make available to the public, in a timely manner, 

12 data regarding such device stratified by gender, race, and 

13 ethnicity.’’. 

14 (e) INVESTIGATIONAL DEVICE EXEMPTIONS.—Sec15 tion 520(g)(2) of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 360j(g)) is amended— 

17 (1) in subparagraph (B), by adding at the end 

18 the following: 

19 ‘‘(iv) A requirement that any application in20 clude information regarding the device, to the extent 

21 appropriate, stratified by gender, race, and ethnicity, 

22 including differences in safety and effectiveness.’’; 

23 and 

24 (2) by adding at the end the following: 
9 

•S 2278 IS

1 ‘‘(d) The Secretary shall develop standards that en2 sure that submissions to the Secretary pursuant to this 

3 subsection are adequately reviewed to determine whether 

4 such submissions include the information required under 

5 paragraph (B)(iv).’’. 

6 (f) BIOLOGICAL PRODUCT LICENSES.—Section 

7 351(a)(2) of the Public Health Service Act (42 U.S.C. 

8 262) is amended by adding at the end the following: 

9 ‘‘(D)(i) Notwithstanding any other provision of this 

10 Act, the applicant shall include in any application to the 

11 Secretary pursuant to this section appropriate information 

12 regarding the subject biological product stratified by gen13 der, race, and ethnicity, including differences in safety and 

14 effectiveness. 

15 ‘‘(ii) The Secretary shall develop standards that en16 sure that submissions to the Secretary pursuant to this 

17 section are adequately reviewed to determine whether such 

18 submissions include the information required under para19 graph (D)(i). 

20 ‘‘(iii) Upon the approval of an application under this 

21 subsection, the Secretary shall report to the scientific com22 munity and make available to the public, in a timely man23 ner, data regarding such biological product stratified by 

24 gender, race, and ethnicity.’’. 
10 

•S 2278 IS

1 (g) GAO STUDY.—Not later than 2 years after the 

2 date of enactment of this section, the Comptroller General 

3 of the United States shall study the drug approval proc4 esses of the Food and Drug Administration to ensure that 

5 the Food and Drug Administration is complying with the 

6 amendments made by this section. 

7 SEC. 4. GENDER-BASED REPORTING AND ANALYSIS OF PA8 TIENT SAFETY DATA. 

9 (a) DATA STANDARDS.—Section 923(b) of the Public 

10 Health Service Act (as amended by the Patient Safety and 

11 Quality Improvement Act of 2005 (Public law 109–41)) 

12 is amended by adding at the end the following: ‘‘The Sec13 retary shall provide that all nonidentifiable patient safety 

14 work product reported to and among the network of pa15 tient safety databases be stratified by gender.’’. 

16 (b) USE OF INFORMATION.—Section 923(c) of the 

17 Public Health Service Act (as amended by the Patient 

18 Safety and Quality Improvement Act of 2005 (Public law 

19 109–41)) is amended by adding at the end the following: 

20 ‘‘Such analyses take into account data that specifically re21 lates to women and any disparities between treatment and 

22 the quality of care between males and females.’’. 
11 

•S 2278 IS

1 SEC. 5. REPORTING OF HOSPITAL QUALITY DATA BY GEN2 DER. 

3 Section 1886(b)(3)(B)(iv)(II) of the Social Security 

4 Act (42 U.S.C. 1395ww(b)(3)(B)(vii)(II)), as amended by 

5 section 501 of the Medicare Prescription Drug, Improve6 ment, and modernization Act of 2003 (Public law 108– 

7 173), is amended by adding at the end the following: ‘‘The 

8 Secretary shall make such data available to the public, in 

9 a form and manner that stratifies the data by gender.’’. 

10 SEC. 6. QUALITY OF CARE REPORTS BY THE AGENCY FOR 

11 HEALTHCARE RESEARCH AND QUALITY. 

12 Section 903 of the Public Health Service Act (42 

13 U.S.C. 299a–1) is amended— 

14 (1) in subsection (b)(1)(B), by inserting before 

15 the semicolon the following: ‘‘, including quality of 

16 and access to care for women with heart disease, 

17 stroke, and other cardiovascular disease’’; and 

18 (2) in subsection (c), by adding at the end the 

19 following: 

20 ‘‘(4) ANNUAL REPORT ON WOMEN AND HEART

21 DISEASE.—Not later than September 30, 2006, and 

22 annually thereafter, the Secretary, acting through 

23 the Director, shall prepare and submit to Congress 

24 a report concerning the findings related to the qual25 ity of and access to care for women with heart dis26 ease, stroke, and other cardiovascular diseases. The 
12 

•S 2278 IS

1 report shall contain recommendations for eliminating 

2 disparities in, and improving the treatment of, heart 

3 disease, stroke, and other cardiovascular diseases in 

4 women.’’. 

5 SEC. 7. ANALYSIS OF DATA BY QUALITY IMPROVEMENT OR6 GANIZATIONS. 

7 Section 1154(a) of the Social Security Act (42 U.S.C. 

8 1320c–3(a)) is amended by adding at the end the fol9 lowing: 

10 ‘‘(18) The organization shall execute its respon11 sibilities under subparagraphs (A) and (B) of para12 graph (1) by offering to providers, practitioners, 

13 Medicare Advantage organizations under part C, 

14 and prescription drug sponsors offering prescription 

15 drug plans under part D quality improvement assist16 ance aimed at eliminating gender disparities in the 

17 quality of care for women, particularly minority 

18 women, who suffer from heart disease, stroke, and 

19 other cardiovascular diseases. For purposes of this 

20 part and title XVIII, the functions described in this 

21 paragraph shall be treated as a review function.’’. 

22 SEC. 8. REPORTS BY ACCREDITING ORGANIZATIONS. 

23 The Social Security Act is amended by inserting after 

24 section 1808 (42 U.S.C. 1395b–9) the following: 
13 

•S 2278 IS

1 ‘‘SEC. 1809. STRATIFICATION OF DATA BY GENDER IN AP2 PLYING CONDITIONS OF PARTICIPATION AND 

3 CONDITIONS OF COVERAGE. 

4 ‘‘The Secretary shall ensure that data are stratified 

5 by gender when collected and used in surveys evaluating 

6 whether providers meet the applicable conditions of par7 ticipation or conditions of coverage under parts A, B, C, 

8 and D of this title. When determined feasible by the Sec9 retary, such data shall be stratified by gender when re10 ported to the public or otherwise made available to the 

11 public.’’. 

12 SEC. 9. EDUCATIONAL CAMPAIGNS. 

13 (a) DISTRIBUTION OF EDUCATIONAL MATERIAL

14 THROUGH THE CENTER FOR BENEFICIARY CHOICES.— 

15 The Secretary of Health and Human Services, acting 

16 through the Center for Beneficiary Choices of the Centers 

17 for Medicare & Medicaid Services, shall develop and dis18 tribute to female medicare beneficiaries, physicians, and 

19 other appropriate healthcare professionals educational ma20 terials relating to the prevention, diagnosis, and treatment 

21 of heart disease, stroke, and cardiovascular diseases in 

22 women. The Center for Beneficiary Choices may carry out 

23 this subsection through contracts with public and private 

24 nonprofit entities. 

25 (b) HEALTHCARE PROFESSIONAL EDUCATIONAL

26 CAMPAIGN.—The Secretary of Health and Human Serv-
14 

•S 2278 IS

1 ices, acting through the Bureau of Health Professions of 

2 the Health Resources and Services Administration, shall 

3 conduct an education and awareness campaign for physi4 cians and other healthcare professionals relating to the 

5 prevention, diagnosis, and treatment of heart disease, 

6 stroke, and other cardiovascular diseases in women. The 

7 Bureau of Health Professions may carry out this sub8 section through contracts with public and private non9 profit entities. 

10 SEC. 10. EXTENSION OF WISEWOMAN. 

11 There are authorized to be appropriated such sums 

12 as may be necessary for each fiscal year to enable the Di13 rector of the Centers for Disease Control and Prevention 

14 to implement Well-Integrated Screening and Evaluation 

15 for Women Across the Nation (WISEWOMAN) program 

16 projects in all State and territories, which may include 

17 projects among Indian tribes. 

Æ