1.This Act may be cited as the
Heart Disease Education, Analysis,
Research, and Treatment for Women Act
or the
HEART for Women
Act
.
2.Reporting of data
in applications for drugs, biologics, and devices
(a)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)
(1)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)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 Website.
(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)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.
(d)Biennial
reports by the Food and Drug AdministrationNot 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)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)).
3.Reporting on
quality of and access to care for women with cardiovascular
diseasesPart 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:
399V–6.Reporting on
quality of and access to care for women with cardiovascular
diseasesNot later than
September 30, 2014, and annually thereafter, the Secretary 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.
.
4.Extension of WISEWOMAN
program
(a)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
; and
(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.
.
(b)
(1)The Secretary of Health and Human Services shall
(directly or through grants or contracts) conduct a study of the impact of the
Patient Protection and Affordable Care Act (Public Law 111–148) on the
preventive health services, referrals, and follow-up services authorized under
section 1509 of the Public Health Service Act (42 U.S.C. 300n–4a), as amended
by this section.
(2)Not
later than 18 months after the date of enactment of this Act, the Secretary of
Health and Human Services shall complete the study required by paragraph (1)
and submit a report 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 containing the results of the study and recommendations for
improving the provision of services to eligible women authorized under such
section 1509.