S 438
112th CONGRESS
1st Session
S. 438
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.
IN THE SENATE OF THE UNITED STATES
March 2, 2011
Ms. STABENOW (for herself, Ms. MURKOWSKI, and Ms. COLLINS) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
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.
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.
(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 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) 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.
(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
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.
(a) In General- Section 1509 of the Public Health Service Act (42 U.S.C.
300n-4a) is amended--
(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.'.
(1) IN GENERAL- 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) REPORT- 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.
END
