1.This Act may be cited as
the Heart Disease Education, Analysis,
and Research, and Treatment for Women Act
or the
HEART for Women Act
.
2.Congress makes the following
findings:
(1)Heart disease,
stroke, and other cardiovascular 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
diseases, 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
disease is the leading killer of women.
(5)Women are less
likely than men to receive certain treatments for cardiovascular diseases,
perhaps 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.
3.Reporting of
gender data in applications for drugs, biologics, and devices
(a)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 appropriate,
information stratified by gender, race and ethnicity, including any differences
in safety and effectiveness.
(B)The Secretary
shall withhold approval of an application if the applicant fails to submit the
required information described in subparagraph (A).
(C)The Secretary
shall develop standards to ensure that submissions to the Secretary pursuant to
this subsection are adequately reviewed to determine whether such submissions
include the information required under subparagraph (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 applicationsSection 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 paragraph (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 Secretary pursuant to this
subsection on the clinical investigation of the new drug and to the extent
appropriate, information stratified by gender, race, and ethnicity, including
any differences in safety and effectiveness.
(B)The Secretary shall place a clinical
hold (as described in paragraph (3)) on an investigation if the manufacturer or
sponsor of the investigation fails to submit the required information described
in subparagraph (A).
(C)The Secretary shall develop standards
that ensure that submissions to the Secretary pursuant to this subsection on
clinical investigations of new drugs are adequately reviewed to determine
whether such submissions include the information required under this
paragraph.
.
(c)Abbreviated new
drug applicationsSection 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 paragraph (10)
;
(2)in paragraph
(3)(A), by adding at the end the following: The Secretary shall require
such individuals 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 appropriate information stratified by gender, race, and
ethnicity, as required under paragraph
(10).
;
and
(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
Secretary pursuant to this subsection appropriate drug information stratified
by gender, race, and ethnicity, including any differences in safety and
effectiveness.
(B)The Secretary shall develop standards
that ensure 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.
.
(d)Section 515 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e) is amended—
(1)in subsection
(c)—
(A)in paragraph
(1)—
(i)in
subparagraph (F), by striking and
at the end;
(ii)in
subparagraph (G), by striking the period and inserting ; and
;
and
(iii)by adding at
the end the following:
(H)information
regarding the device, to the extent appropriate, stratified by gender, race and
ethnicity, including differences in safety and
effectiveness.
;
and
(B)by adding at the
end the following:
(5)The Secretary
shall develop standards that ensure that submissions to the Secretary pursuant
to this subsection are adequately reviewed to determine whether such
submissions include the information required under paragraph
(1)(H).
;
and
(2)in subsection
(d)—
(A)in paragraph
(1)—
(i)in
subparagraph (D), by striking or
at the end;
(ii)in
subparagraph (E), by striking the period and inserting ; or
;
and
(iii)by inserting
after subparagraph (E), the following:
(F)the application
does not contain, as appropriate, the information required in subsection
(c)(1)(H).
;
and
(B)by adding at the
end the following:
(7)Upon the approval
of an application under this section, the Secretary shall report to the
scientific community and make available to the public, in a timely manner, data
regarding such device stratified by gender, race, and
ethnicity.
.
(e)Investigational
device exemptionsSection 520(g)(2) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j(g)) is amended—
(1)in subparagraph
(B), by adding at the end the following:
(iv)A requirement
that any application include information regarding the device, to the extent
appropriate, stratified by gender, race, and ethnicity, including differences
in safety and effectiveness.
;
and
(2)by adding at the
end the following:
(d)The Secretary
shall develop standards that ensure that submissions to the Secretary pursuant
to this subsection are adequately reviewed to determine whether such
submissions include the information required under paragraph
(B)(iv).
.
(f)Biological
product licensesSection 351(a)(2) of the Public Health Service
Act (42 U.S.C. 262) is amended by adding at the end the following:
(D)(i)Notwithstanding
any other provision of this Act, the applicant shall include in any application
to the Secretary pursuant to this section appropriate information regarding the
subject biological product stratified by gender, race, and ethnicity, including
differences in safety and effectiveness.
(ii)The Secretary
shall develop standards that ensure that submissions to the Secretary pursuant
to this section are adequately reviewed to determine whether such submissions
include the information required under paragraph (D)(i).
(iii)Upon the
approval of an application under this subsection, the Secretary shall report to
the scientific community and make available to the public, in a timely manner,
data regarding such biological product stratified by gender, race, and
ethnicity.
.
(g)Not later than 2 years after the date of enactment of this
section, the Comptroller General of the United States shall study the drug
approval processes of the Food and Drug Administration to ensure that the Food
and Drug Administration is complying with the amendments made by this
section.
4.Gender-based
reporting and analysis of patient safety data
(a)Section 923(b) of
the Public Health Service Act (as amended by the Patient Safety and Quality
Improvement Act of 2005 (Public law 109–41)) is amended by adding at the end
the following: The Secretary shall provide that all nonidentifiable
patient safety work product reported to and among the network of patient safety
databases be stratified by gender.
.
(b)Section 923(c) of the Public Health Service Act (as
amended by the Patient Safety and Quality Improvement Act of 2005 (Public law
109–41)) is amended by adding at the end the following: Such analyses
take into account data that specifically relates to women and any disparities
between treatment and the quality of care between males and
females.
.
5.Reporting of
hospital quality data by genderSection 1886(b)(3)(B)(iv)(II) of the Social
Security Act (42 U.S.C. 1395ww(b)(3)(B)(vii)(II)), as amended by section 501 of
the Medicare Prescription Drug, Improvement, and modernization Act of 2003
(Public law 108–173), is amended by adding at the end the following: The
Secretary shall make such data available to the public, in a form and manner
that stratifies the data by gender.
.
6.Quality of care
reports by the Agency for Healthcare Research and QualitySection 903 of the Public Health Service Act
(42 U.S.C. 299a–1) is amended—
(1)in subsection (b)(1)(B), by inserting
before the semicolon the following: , including quality of and access to
care for women with heart disease, stroke, and other cardiovascular
disease
; and
(2)in subsection
(c), by adding at the end the following:
(4)Annual report
on women and heart diseaseNot later than September 30, 2006, and
annually thereafter, the Secretary, acting through the Director, shall prepare
and submit to Congress a report concerning the findings related to the quality
of and access to care for women with heart disease, stroke, and other
cardiovascular diseases. The report shall contain recommendations for
eliminating disparities in, and improving the treatment of, heart disease,
stroke, and other cardiovascular diseases in
women.
.
7.Analysis of data
by quality improvement organizationsSection 1154(a) of the Social Security Act
(42 U.S.C. 1320c–3(a)) is amended by adding at the end the following:
(18)The organization
shall execute its responsibilities under subparagraphs (A) and (B) of paragraph
(1) by offering to providers, practitioners, Medicare Advantage organizations
under part C, and prescription drug sponsors offering prescription drug plans
under part D quality improvement assistance aimed at eliminating gender
disparities in the quality of care for women, particularly minority women, who
suffer from heart disease, stroke, and other cardiovascular diseases. For
purposes of this part and title XVIII, the functions described in this
paragraph shall be treated as a review
function.
.
8.Reports by
accrediting organizationsThe
Social Security Act is amended by inserting after section 1808 (42 U.S.C.
1395b–9) the following:
1809.Stratification
of data by gender in applying conditions of participation and conditions of
coverage
The Secretary
shall ensure that data are stratified by gender when collected and used in
surveys evaluating whether providers meet the applicable conditions of
participation or conditions of coverage under parts A, B, C, and D of this
title. When determined feasible by the Secretary, such data shall be stratified
by gender when reported to the public or otherwise made available to the
public.
.
9.
(a)Distribution of
educational material through the Center for Beneficiary
ChoicesThe Secretary of Health and Human Services, acting
through the Center for Beneficiary Choices of the Centers for Medicare &
Medicaid Services, shall develop and distribute to female medicare
beneficiaries, physicians, and other appropriate healthcare professionals
educational materials relating to the prevention, diagnosis, and treatment of
heart disease, stroke, and cardiovascular diseases in women. The Center for
Beneficiary Choices may carry out this subsection through contracts with public
and private nonprofit entities.
(b)Healthcare
professional educational campaignThe Secretary of Health and
Human Services, acting through the Bureau of Health Professions of the Health
Resources and Services Administration, shall conduct an education and awareness
campaign for physicians and other healthcare professionals relating to the
prevention, diagnosis, and treatment of heart disease, stroke, and other
cardiovascular diseases in women. The Bureau of Health Professions may carry
out this subsection through contracts with public and private nonprofit
entities.
10.There are authorized
to be appropriated such sums as may be necessary for each fiscal year to enable
the Director of the Centers for Disease Control and Prevention to implement
Well-Integrated Screening and Evaluation for Women Across the Nation
(WISEWOMAN) program projects in all State and territories, which may include
projects among Indian tribes.