IIB
111th CONGRESS
2d Session
H. R. 1032
IN THE SENATE OF THE UNITED STATES
November 15, 2010
Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions
AN ACT
To amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.
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
.
Report by Government Accountability Office
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.
Report by GAO
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.
Contents
The report required by paragraph (1) shall include each of the following:
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).
A description of the effectiveness of the Food and Drug Administration’s enforcement of compliance with such requirements.
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.
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 Website.
Appropriate recommendations for—
modifications to the requirements and guidance referred to in subsection (a); or
oversight by the Food and Drug Administration of such requirements.
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 that report, including a corrective action plan as needed to respond to the recommendations in that report.
Definitions
In this section:
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)).
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)).
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)).
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:
Reporting on quality of and access to care for women with cardiovascular diseases
Not later than September 30, 2013, 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.
.
Extension of WISEWOMAN program
Section 1509 of the Public Health Service Act (42 U.S.C. 300n–4a) is amended—
in subsection (a)—
by striking the
heading and inserting In
general.—
; and
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
; and
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.
.
Passed the House of Representatives September 30 (legislative day September 29), 2010.
Lorraine C. Miller,
Clerk