Heart Disease Education, Analysis, Research, and Treatment for Women Act or the HEART for Women Act - Directs the Comptroller General to report on whether the presentation of clinical study safety and effectiveness data by sex, age, and racial subgroups complies with Food and Drug Administration (FDA) requirements. Requires the Secretary of Health and Human Services (HHS) to submit a response to such report, including a corrective action plan as needed.
Requires the Director of the Office of Women's Health of FDA to report on the compliance of clinical studies of women's health with such FDA requirements, including requirements regarding: (1) the adequacy of representation of females, racial and ethnic minorities, and adults of all ages in approved clinical studies; and (2) the extent to which a summary of product safety and effectiveness data disaggregated by sex, age, and racial subgroup is available to the public. Requires the Director of the Office of Minority Health of FDA to submit a report that includes such information with respect to clinical studies of minority health.
Amends the Public Health Service Act to require the Secretary to report on the quality of, and access to, care for women with heart disease, stroke, and other cardiovascular diseases and to include recommendations for eliminating disparities in, and improving the treatment of, heart disease, stroke, and other cardiovascular diseases in women.
Reauthorizes a program to award grants for preventive heath services and referrals for medical treatment for women through entities that are screening women for breast or cervical cancer. Requires the Secretary to study the impact of the Patient Protection and Affordable Care Act on such services and make recommendations for improvement in the provision of preventive health services, referrals, and followup services to women eligible for such services.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3526 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 3526
To amend the Public Health Service Act to improve women's health by
prevention, diagnosis, and treatment of heart disease, stroke, and
other cardiovascular diseases in women, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 30, 2011
Mrs. Capps introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to improve women's health by
prevention, diagnosis, and treatment of heart disease, stroke, and
other cardiovascular diseases in women, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Heart Disease Education, Analysis,
Research, and Treatment for Women Act'' or the ``HEART for Women Act''.
SEC. 2. REPORTING OF DATA IN APPLICATIONS FOR DRUGS, BIOLOGICS, AND
DEVICES.
(a) In General.--The Comptroller General of the United States shall
conduct a study investigating the extent to which sponsors of clinical
studies of investigational drugs, biologics, and devices and sponsors
of applications for approval or licensure of new drugs, biologics, and
devices comply with Food and Drug Administration requirements and
follow guidance for presentation of clinical study safety and
effectiveness data by sex, age, and racial subgroups.
(b) Report by GAO.--
(1) Submission.--Not later than 12 months after the date of
the enactment of this Act, the Comptroller General shall
complete the study under subsection (a) and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report on the results of such
study.
(2) Contents.--The report required by paragraph (1) shall
include each of the following:
(A) A description of the extent to which the Food
and Drug Administration assists sponsors in complying
with the requirements and following the guidance
referred to in subsection (a).
(B) A description of the effectiveness of the Food
and Drug Administration's enforcement of compliance
with such requirements.
(C) An analysis of the extent to which females,
racial and ethnic minorities, and adults of all ages
are adequately represented in Food and Drug
Administration-approved clinical studies (at all
phases) so that product safety and effectiveness data
can be evaluated by gender, age, and racial subgroup.
(D) An analysis of the extent to which a summary of
product safety and effectiveness data disaggregated by
sex, age, and racial subgroup is readily available to
the public in a timely manner by means of the product
label or the Food and Drug Administration's Web site.
(E) Appropriate recommendations for--
(i) modifications to the requirements and
guidance referred to in subsection (a); or
(ii) oversight by the Food and Drug
Administration of such requirements.
(c) Report by HHS.--Not later than 6 months after the submission by
the Comptroller General of the report required under subsection (b),
the Secretary of Health and Human Services shall submit to the
Committee on Energy and Commerce of the House of Representatives and
the Committee on Health, Education, Labor, and Pensions of the Senate a
response to such report, including a corrective action plan as needed
to respond to the recommendations in such report.
(d) Biennial Reports by the Food and Drug Administration.--Not
later than 2 years after the date of enactment of this Act, and every 2
years thereafter--
(1) the Director of the Office of Women's Health of the
Food and Drug Administration shall submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate, a report that includes each of the elements described
in subparagraphs (A) through (E) of subsection (b)(2), with
respect to women's health; and
(2) the Director of the Office of Minority Health of the
Food and Drug Administration shall submit to such Committees a
report that includes each of such elements, with respect to
minority health.
(e) Definitions.--In this section:
(1) The term ``biologic'' has the meaning given to the term
``biological product'' in section 351(i) of the Public Health
Service Act (42 U.S.C. 262(i)).
(2) The term ``device'' has the meaning given to such term
in section 201(h) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(h)).
(3) The term ``drug'' has the meaning given to such term in
section 201(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(g)).
SEC. 3. REPORTING ON QUALITY OF AND ACCESS TO CARE FOR WOMEN WITH
CARDIOVASCULAR DISEASES.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following:
``SEC. 399V-6. REPORTING ON QUALITY OF AND ACCESS TO CARE FOR WOMEN
WITH CARDIOVASCULAR DISEASES.
``Not later than September 30, 2014, and annually thereafter, the
Secretary of Health and Human Services shall prepare and submit to the
Congress a report on 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.''.
SEC. 4. EXTENSION OF WISEWOMAN PROGRAM.
Section 1509 of the Public Health Service Act (42 U.S.C. 300n-4a)
is amended--
(1) in subsection (a)--
(A) by striking the heading and inserting ``In
General.--''; and
(B) in the matter preceding paragraph (1), by
striking ``may make grants'' and all that follows
through ``purpose'' and inserting the following: ``may
make grants to such States for the purpose'';
(2) in subsection (d)(1), by striking ``there are
authorized'' and all that follows through the period and
inserting ``there are authorized to be appropriated $23,000,000
for fiscal year 2012, $25,300,000 for fiscal year 2013,
$27,800,000 for fiscal year 2014, $30,800,000 for fiscal year
2015, and $34,000,000 for fiscal year 2016.''; and
(3) by adding at the end the following new subsection:
``(e) Study.--
``(1) The Secretary shall (directly or through grants or
contracts) conduct a study of the impact of the Patient
Protection and Affordable Care Act on the preventive health
services, referrals, and follow-up services described in
subsection (a).
``(2) Not later than 18 months after the date of enactment
of this subsection, the Secretary shall submit to the Committee
on Energy and Commerce of the House of Representatives and to
the Committee on Health, Education, Labor, and Pensions of the
Senate a report containing the results of the study under
paragraph (1) and recommendations for improving the provision
of preventive health services, referrals, and follow-up
services described in paragraph (1) to women eligible for such
services under grants funded under this section.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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