I 
109TH CONGRESS 
2D SESSION 
H. R. 4747 
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 HOUSE OF REPRESENTATIVES 
FEBRUARY 14, 2006 
Mrs. CAPPS (for herself and Mrs. CUBIN) introduced the following bill; which 
was referred to the Committee on Energy and Commerce, and in addition 
to the Committee on Ways and Means, for a period to be subsequently 
determined by the Speaker, in each case for consideration of such provi-
sions as fall within the jurisdiction of the committee concerned 
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. 
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, and Research, and Treatment for Women 
Act’’ or the ‘‘HEART for Women Act’’. 
SEC. 2. FINDINGS. 
Congress makes the following findings:
(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, and Native American women, 
are at a higher risk of death from heart disease, 
stroke, and other cardiovascular diseases, but they 
are less likely to know of this risk. 
(4) There is a pervasive lack of awareness 
among health care 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. 
(7) Certain diagnostic tests for cardiovascular 
disease may be less accurate in women than 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 gender differences in the effects, diagnosis, 
and treatment of stroke. 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 GENDER 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: 
‘‘(5)(A) Notwithstanding any other provision of this 
Act, the applicant shall include in any submission to the 
Secretary pursuant to this subsection, to the extent appro-
priate, information stratified by gender, race and eth-
nicity, including any differences in safety and effective-
ness. 
‘‘(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 
gender, 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-
retary pursuant to this subsection on the clinical investiga-
tion of the new drug and to the extent appropriate, infor-
mation stratified by gender, race, and ethnicity, including 
any differences in safety and effectiveness. 
‘‘(B) The Secretary shall place a clinical hold (as de-
scribed in paragraph (3)) on an investigation if the manu-
facturer or sponsor of the investigation fails to submit the 
required information described in subparagraph (A). 
‘‘(C) The Secretary shall develop standards that en-
sure that submissions to the Secretary pursuant to this 
subsection on clinical investigations of new drugs are ade-
quately reviewed to determine whether such submissions 
include the information required under this paragraph.’’. 
(c) ABBREVIATED NEW DRUG APPLICATIONS.—Sec-
tion 505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)) is amended— 
(1) in paragraph (2)(A), by inserting before the 
period at the end the following: ‘‘, subject to para-
graph (10)’’; 
(2) in paragraph (3)(A), by adding at the end 
the following: ‘‘The Secretary shall require such in-
dividuals who review such applications to ensure 
that such applications include the information on 
gender data required under paragraph (10).’’; 
(3) in paragraph (4)—
(A) in subparagraph (J), by striking ‘‘or’’ 
after the semicolon; 
(B) in subparagraph (K), by striking the 
period at the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(L) the application does not include ap-
propriate information stratified by gender, race, 
and ethnicity, as required under paragraph 
(10).’’. 
(4) by adding at the end the following: 
‘‘(10)(A) Notwithstanding any other provision of this 
Act, a person shall include in any submission to the Sec-
retary pursuant to this subsection appropriate drug infor-
mation stratified by gender, race, and ethnicity, including 
any differences in safety and effectiveness. 
‘‘(B) The Secretary shall develop standards that en-
sure that submissions to the Secretary pursuant to this 
subsection are adequately reviewed to determine whether 
such submissions include the information required under 
this paragraph. 
‘‘(11) 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 
gender, race, and ethnicity.’’.