[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 438 Introduced in Senate (IS)]

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.
    (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 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--
            (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) Study.--
            (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.
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