I 
110TH CONGRESS 
1ST SESSION H. R. 1014 
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 HOUSE OF REPRESENTATIVES 
FEBRUARY 13, 2007 
Mrs. CAPPS (for herself and Mrs. CUBIN) introduced the following bill; which 
was referred to the Committee on Energy and Commerce 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the Heart Disease Edu-
cation, Analysis Research, and Treatment for Women Act 
or the ‘‘HEART for Women Act’’. 
SEC. 2. FINDINGS. 
Congress makes the following findings: 
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(1) Heart disease, stroke, and other cardio-
vascular diseases are the leading cause of death 
among women. 
(2) Despite being the number 1 killer, only 13 
percent of women are aware that cardiovascular dis-
eases, including heart disease and stroke, are their 
greatest health risk. 
(3) Many minority women, including African 
American, Hispanic, Native American, and some 
Asian American women, are at a higher risk of 
death from heart disease, stroke, and other cardio-
vascular diseases, but they are less likely to know of 
this risk. 
(4) There is a pervasive lack of awareness 
among healthcare providers that cardiovascular dis-
ease is the leading killer of women. 
(5) Women are less likely than men to receive 
certain treatments for cardiovascular diseases, per-
haps due to lack of awareness and the presence of 
different symptoms in women than in men. 
(6) Women tend to experience later onset of 
heart disease than men, and therefore more often 
suffer from multiple conditions that mask symptoms 
of heart disease and complicate treatment. 
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(7) Certain diagnostic tests for cardiovascular 
disease may be less accurate in women than in men. 
(8) Drug effectiveness and metabolism differ in 
women and men, impacting successful treatment of 
cardiovascular disease. 
(9) In addition, stroke kills 2.3 times as many 
females as does breast cancer. Nearly 61 percent of 
stroke-related deaths occur in females. Studies have 
found differences in the effects, diagnosis, and treat-
ment of stroke depending on the sex of the patient. 
For instance— 
(A) stroke severity is greater in women 
than in men; 
(B) women often receive fewer diagnostic 
tests and intervention procedures than men; 
and 
(C) 
strokes 
present 
treatment 
issues 
unique to women. 
SEC. 3. REPORTING OF DATA IN APPLICATIONS FOR 
DRUGS, BIOLOGICS, AND DEVICES. 
(a) NEW DRUG APPLICATIONS.—Section 505(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)) is amended by adding at the end the following: 
‘‘(6)(A) Notwithstanding any other provision of this 
Act, the applicant shall include in any submission to the 
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Secretary pursuant to this subsection, to the extent appro-
priate, information stratified by sex, race, and ethnicity, 
including any differences in safety and effectiveness. 
‘‘(B) The Secretary shall withhold approval of an ap-
plication if the applicant fails to submit the required infor-
mation described in subparagraph (A). 
‘‘(C) The Secretary shall develop standards to ensure 
that submissions to the Secretary pursuant to this sub-
section are adequately reviewed to determine whether such 
submissions include the information required under sub-
paragraph (A). 
‘‘(D) Upon the approval under this subsection of an 
application for a drug, the Secretary shall report to the 
scientific community and make available to the public, in 
a timely manner, data regarding such drug stratified by 
sex, race, and ethnicity.’’. 
(b) INVESTIGATIONAL NEW DRUG APPLICATIONS.— 
Section 505(i) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(i)) is amended— 
(1) in paragraph (2), by inserting ‘‘and para-
graph (5)’’ after ‘‘Subject to paragraph (3)’’; and 
(2) by adding at the end the following: 
‘‘(5)(A) Notwithstanding any other provision of this 
Act, the manufacturer or sponsor of an investigation of 
a new drug shall include in any submission to the Sec-
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