II 

110TH CONGRESS 

1ST SESSION S. 573 

To amend the Federal Food, Drug, and Cosmetic Act and 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 13, 2007 

Ms. STABENOW (for herself, Ms. MURKOWSKI, Ms. COLLINS, Ms. SNOWE, Mr. 

AKAKA, Mr. COCHRAN, and Mr. MENENDEZ) introduced the following 

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

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act and 

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’’. 

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1 SEC. 2. FINDINGS. 

2 Congress makes the following findings: 

3 (1) Heart disease, stroke, and other cardio4 vascular diseases are the leading cause of death 

5 among women. 

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

7 percent of women are aware that cardiovascular dis8 eases, including heart disease and stroke, are their 

9 greatest health risk. 

10 (3) Many minority women, including African 

11 American, Hispanic, Native American, and some 

12 Asian American women, are at a higher risk of 

13 death from heart disease, stroke, and other cardio14 vascular diseases, but they are less likely to know of 

15 this risk. 

16 (4) There is a pervasive lack of awareness 

17 among healthcare providers that cardiovascular dis18 ease is the leading killer of women. 

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

20 certain treatments for cardiovascular diseases, per21 haps due to lack of awareness and the presence of 

22 different symptoms in women than in men. 

23 (6) Women tend to experience later onset of 

24 heart disease than men, and therefore more often 

25 suffer from multiple conditions that mask symptoms 

26 of heart disease and complicate treatment. 

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1 (7) Certain diagnostic tests for cardiovascular 

2 disease may be less accurate in women than in men. 

3 (8) Drug effectiveness and metabolism differ in 

4 women and men, impacting successful treatment of 

5 cardiovascular disease. 

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

7 females as does breast cancer. Nearly 61 percent of 

8 stroke-related deaths occur in females. Studies have 

9 found differences in the effects, diagnosis, and treat10 ment of stroke depending on the sex of the patient. 

11 For instance— 

12 (A) stroke severity is greater in women 

13 than in men; 

14 (B) women often receive fewer diagnostic 

15 tests and intervention procedures than men; 

16 and 

17 (C) strokes present treatment issues 

18 unique to women. 

19 SEC. 3. REPORTING OF DATA IN APPLICATIONS FOR 

20 DRUGS, BIOLOGICS, AND DEVICES. 

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

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

23 355(b)) is amended by adding at the end the following: 

24 ‘‘(6)(A) Notwithstanding any other provision of this 

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

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1 Secretary pursuant to this subsection, to the extent appro2 priate, information stratified by sex, race, and ethnicity, 

3 including any differences in safety and effectiveness. 

4 ‘‘(B) The Secretary shall withhold approval of an ap5 plication if the applicant fails to submit the required infor6 mation described in subparagraph (A). 

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

8 that submissions to the Secretary pursuant to this sub9 section are adequately reviewed to determine whether such 

10 submissions include the information required under sub11 paragraph (A). 

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

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

14 scientific community and make available to the public, in 

15 a timely manner, data regarding such drug stratified by 

16 sex, race, and ethnicity.’’. 

17 (b) INVESTIGATIONAL NEW DRUG APPLICATIONS.— 

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

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

20 (1) in paragraph (2), by inserting ‘‘and para21 graph (5)’’ after ‘‘Subject to paragraph (3)’’; and 

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

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

24 Act, the manufacturer or sponsor of an investigation of 

25 a new drug shall include in any submission to the Secmstockstill on PROD1PC66 with BILLS

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1 retary pursuant to this subsection on the clinical investiga2 tion of the new drug and to the extent appropriate, infor3 mation stratified by sex, race, and ethnicity, including any 

4 differences in safety and effectiveness. 

5 ‘‘(B) The Secretary shall place a clinical hold (as de6 scribed in paragraph (3)) on an investigation if the manu7 facturer or sponsor of the investigation fails to submit the 

8 required information described in subparagraph (A). 

9 ‘‘(C) The Secretary shall develop standards that en10 sure that submissions to the Secretary pursuant to this 

11 subsection on clinical investigations of new drugs are ade12 quately reviewed to determine whether such submissions 

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

14 (c) ABBREVIATED NEW DRUG APPLICATIONS.—Sec15 tion 505(j) of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 355(j)) is amended— 

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

18 period at the end the following: ‘‘, subject to para19 graph (10)’’; 

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

21 the following: ‘‘The Secretary shall require such in22 dividuals who review such applications to ensure 

23 that such applications include the information on 

24 sex, race, and ethnicity data required under para25 graph (10).’’; 

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1 (3) in paragraph (4)— 

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

3 after the semicolon; 

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

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

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

7 ‘‘(L) the application does not include ap8 propriate information stratified by sex, race, 

9 and ethnicity, as required under paragraph 

10 (10).’’; and 

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

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

13 Act, a person shall include in any submission to the Sec14 retary pursuant to this subsection appropriate drug infor15 mation stratified by sex, race, and ethnicity, including any 

16 differences in safety and effectiveness. 

17 ‘‘(B) 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 this paragraph. 

22 ‘‘(C) Upon the approval under this subsection of an 

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

24 scientific community and make available to the public, in 

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1 a timely manner, data regarding such drug stratified by 

2 sex, race, and ethnicity.’’. 

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

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

5 is amended— 

6 (1) in subsection (c)— 

7 (A) in paragraph (1)— 

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

9 ‘‘and’’ at the end; 

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

11 the period and inserting ‘‘; and’’; and 

12 (iii) by adding at the end the fol13 lowing: 

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

15 extent appropriate, stratified by sex, race, and eth16 nicity, including differences in safety and effective17 ness.’’; and 

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

19 ‘‘(5) The Secretary shall develop standards that en20 sure that submissions to the Secretary pursuant to this 

21 subsection are adequately reviewed to determine whether 

22 such submissions include the information required under 

23 paragraph (1)(H).’’; and 

24 (2) in subsection (d)— 

25 (A) in paragraph (2)— 

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

2 ‘‘or’’ at the end; 

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

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

5 (iii) by inserting after subparagraph 

6 (E), the following: 

7 ‘‘(F) the application does not contain, as appro8 priate, the information required in subsection 

9 (c)(1)(H).’’; and 

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

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

12 section, the Secretary shall report to the scientific commu13 nity and make available to the public, in a timely manner, 

14 data regarding such device stratified by sex, race, and eth15 nicity.’’. 

16 (e) INVESTIGATIONAL DEVICE EXEMPTIONS.—Sec17 tion 520(g)(2) of the Federal Food, Drug, and Cosmetic 

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

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

20 the following: 

21 ‘‘(iv) A requirement that any application in22 clude information regarding the device, to the extent 

23 appropriate, stratified by sex, race, and ethnicity, in24 cluding differences in safety and effectiveness.’’; and 

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

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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 subparagraph (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 sex, 

13 race, and ethnicity, including differences in safety and ef14 fectiveness. 

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 clause 

19 (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 sex, race, and ethnicity.’’. 

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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. REPORTING AND ANALYSIS OF PATIENT SAFETY 

8 DATA. 

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

10 Health Service Act (42 U.S.C. 299b–23(b)) is amended 

11 by adding at the end the following: ‘‘The Secretary shall 

12 provide that all nonidentifiable patient safety work prod13 uct reported to and among the network of patient safety 

14 databases be stratified by sex.’’. 

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

16 Public Health Service Act (42 U.S.C. 299b–23(c)) is 

17 amended by adding at the end the following: ‘‘Such anal18 yses take into account data that specifically relates to 

19 women and any disparities between treatment and the 

20 quality of care between males and females.’’. 

21 SEC. 5. QUALITY OF CARE REPORTS BY THE AGENCY FOR 

22 HEALTHCARE RESEARCH AND QUALITY. 

23 Section 903 of the Public Health Service Act (42 

24 U.S.C. 299a–1) is amended— 

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

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

3 and access to care for women with heart disease, 

4 stroke, and other cardiovascular diseases’’; and 

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

6 following: 

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

8 DISEASE.—Not later than September 30, 2007, and 

9 annually thereafter, the Secretary, acting through 

10 the Director, shall prepare and submit to Congress 

11 a report concerning the findings related to the qual12 ity of and access to care for women with heart dis13 ease, stroke, and other cardiovascular diseases. The 

14 report shall contain recommendations for eliminating 

15 disparities in, and improving the treatment of, heart 

16 disease, stroke, and other cardiovascular diseases in 

17 women.’’. 

18 SEC. 6. EDUCATIONAL CAMPAIGNS. 

19 (a) DISTRIBUTION OF EDUCATIONAL MATERIAL.— 

20 The Secretary of Health and Human Services (referred 

21 to in this section as the ‘‘Secretary’’) shall develop and 

22 distribute to females who are age 65 or older, physicians, 

23 and other appropriate healthcare professionals, edu24 cational materials relating to the prevention, diagnosis, 

25 and treatment of heart disease, stroke, and cardiovascular 

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1 diseases in women. The Secretary may carry out this sub2 section through contracts with public and private non3 profit entities. 

4 (b) HEALTHCARE PROFESSIONAL EDUCATIONAL

5 CAMPAIGN.—The Secretary, acting through the Bureau of 

6 Health Professions of the Health Resources and Services 

7 Administration, shall conduct an education and awareness 

8 campaign for physicians and other healthcare profes9 sionals relating to the prevention, diagnosis, and treat10 ment of heart disease, stroke, and other cardiovascular 

11 diseases in women. The Bureau of Health Professions may 

12 carry out this subsection through contracts with public 

13 and private nonprofit entities. 

14 SEC. 7. EXTENSION OF WISEWOMAN. 

15 There are authorized to be appropriated such sums 

16 as may be necessary for each fiscal year to enable the Di17 rector of the Centers for Disease Control and Prevention 

18 to implement Well-Integrated Screening and Evaluation 

19 for Women Across the Nation (WISEWOMAN) program 

20 projects in all States and territories, which may include 

21 projects among Indian tribes. 

Æ 

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