[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2278 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 2278

   To amend the Public Health Service Act to improve the prevention, 
     diagnosis, and treatment of heart disease, stroke, and other 
                   cardiovascular diseases in women.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 14, 2006

 Ms. Stabenow (for herself and Ms. Murkowski) 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 the 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, 
and Research, and Treatment for Women Act'' or the ``HEART for Women 
Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Heart disease, stroke, and other cardiovascular 
        diseases are the leading cause of death among women.
            (2) Despite being the number 1 killer, only 13 percent of 
        women are aware that cardiovascular diseases, including heart 
        disease and stroke, are their greatest health risk.
            (3) Many minority women, including African American, 
        Hispanic, and Native American women, are at a higher risk of 
        death from heart disease, stroke, and other cardiovascular 
        diseases, but they are less likely to know of this risk.
            (4) There is a pervasive lack of awareness among health 
        care providers that cardiovascular disease is the leading 
        killer of women.
            (5) Women are less likely than men to receive certain 
        treatments for cardiovascular diseases, perhaps due to lack of 
        awareness and the presence of different symptoms in women than 
        in men.
            (6) Women tend to experience later onset of heart disease 
        than men, and therefore more often suffer from multiple 
        conditions that mask symptoms of heart disease and complicate 
        treatment.
            (7) Certain diagnostic tests for cardiovascular disease may 
        be less accurate in women than men.
            (8) Drug effectiveness and metabolism differ in women and 
        men, impacting successful treatment of cardiovascular disease.
            (9) In addition, stroke kills 2.3 times as many females as 
        does breast cancer. Nearly 61 percent of stroke-related deaths 
        occur in females. Studies have found gender differences in the 
        effects, diagnosis, and treatment of stroke. For instance--
                    (A) stroke severity is greater in women than in 
                men;
                    (B) women often receive fewer diagnostic tests and 
                intervention procedures than men; and
                    (C) strokes present treatment issues unique to 
                women.

SEC. 3. REPORTING OF GENDER DATA IN APPLICATIONS FOR DRUGS, BIOLOGICS, 
              AND DEVICES.

    (a) New Drug Applications.--Section 505(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at the 
end the following:
    ``(5)(A) Notwithstanding any other provision of this Act, the 
applicant shall include in any submission to the Secretary pursuant to 
this subsection, to the extent appropriate, information stratified by 
gender, race and ethnicity, including any differences in safety and 
effectiveness.
    ``(B) The Secretary shall withhold approval of an application if 
the applicant fails to submit the required information described in 
subparagraph (A).
    ``(C) The Secretary shall develop standards to ensure that 
submissions to the Secretary pursuant to this subsection are adequately 
reviewed to determine whether such submissions include the information 
required under subparagraph (A).
    ``(D) Upon the approval under this subsection of an application for 
a drug, the Secretary shall report to the scientific community and make 
available to the public, in a timely manner, data regarding such drug 
stratified by gender, race, and ethnicity.''.
    (b) Investigational New Drug Applications.--Section 505(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is amended--
            (1) in paragraph (2), by inserting ``and paragraph (5)'' 
        after ``Subject to paragraph (3)''; and
            (2) by adding at the end the following:
    ``(5)(A) Notwithstanding any other provision of this Act, the 
manufacturer or sponsor of an investigation of a new drug shall include 
in any submission to the Secretary pursuant to this subsection on the 
clinical investigation of the new drug and to the extent appropriate, 
information stratified by gender, race, and ethnicity, including any 
differences in safety and effectiveness.
    ``(B) The Secretary shall place a clinical hold (as described in 
paragraph (3)) on an investigation if the manufacturer or sponsor of 
the investigation fails to submit the required information described in 
subparagraph (A).
    ``(C) The Secretary shall develop standards that ensure that 
submissions to the Secretary pursuant to this subsection on clinical 
investigations of new drugs are adequately reviewed to determine 
whether such submissions include the information required under this 
paragraph.''.
    (c) Abbreviated New Drug Applications.--Section 505(j) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended--
            (1) in paragraph (2)(A), by inserting before the period at 
        the end the following: ``, subject to paragraph (10)'';
            (2) in paragraph (3)(A), by adding at the end the 
        following: ``The Secretary shall require such individuals who 
        review such applications to ensure that such applications 
        include the information on gender data required under paragraph 
        (10).'';
            (3) in paragraph (4)--
                    (A) in subparagraph (J), by striking ``or'' after 
                the semicolon;
                    (B) in subparagraph (K), by striking the period at 
                the end and inserting ``; or''; and
                    (C) by adding at the end the following:
                    ``(L) the application does not include appropriate 
                information stratified by gender, race, and ethnicity, 
                as required under paragraph (10).''; and
            (4) by adding at the end the following:
    ``(10)(A) Notwithstanding any other provision of this Act, a person 
shall include in any submission to the Secretary pursuant to this 
subsection appropriate drug information stratified by gender, race, and 
ethnicity, including any differences in safety and effectiveness.
    ``(B) The Secretary shall develop standards that ensure that 
submissions to the Secretary pursuant to this subsection are adequately 
reviewed to determine whether such submissions include the information 
required under this paragraph.
    ``(11) Upon the approval under this subsection of an application 
for a drug, the Secretary shall report to the scientific community and 
make available to the public, in a timely manner, data regarding such 
drug stratified by gender, race, and ethnicity.''.
    (d) Premarket Approvals.--Section 515 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (F), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (G), by striking the 
                        period and inserting ``; and''; and
                            (iii) by adding at the end the following:
            ``(H) information regarding the device, to the extent 
        appropriate, stratified by gender, race and ethnicity, 
        including differences in safety and effectiveness.''; and
                    (B) by adding at the end the following:
    ``(5) The Secretary shall develop standards that ensure that 
submissions to the Secretary pursuant to this subsection are adequately 
reviewed to determine whether such submissions include the information 
required under paragraph (1)(H).''; and
            (2) in subsection (d)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (D), by striking ``or'' 
                        at the end;
                            (ii) in subparagraph (E), by striking the 
                        period and inserting ``; or''; and
                            (iii) by inserting after subparagraph (E), 
                        the following:
            ``(F) the application does not contain, as appropriate, the 
        information required in subsection (c)(1)(H).''; and
                    (B) by adding at the end the following:
    ``(7) Upon the approval of an application under this section, the 
Secretary shall report to the scientific community and make available 
to the public, in a timely manner, data regarding such device 
stratified by gender, race, and ethnicity.''.
    (e) Investigational Device Exemptions.--Section 520(g)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)) is amended--
            (1) in subparagraph (B), by adding at the end the 
        following:
            ``(iv) A requirement that any application include 
        information regarding the device, to the extent appropriate, 
        stratified by gender, race, and ethnicity, including 
        differences in safety and effectiveness.''; and
            (2) by adding at the end the following:
    ``(d) The Secretary shall develop standards that ensure that 
submissions to the Secretary pursuant to this subsection are adequately 
reviewed to determine whether such submissions include the information 
required under paragraph (B)(iv).''.
    (f) Biological Product Licenses.--Section 351(a)(2) of the Public 
Health Service Act (42 U.S.C. 262) is amended by adding at the end the 
following:
    ``(D)(i) Notwithstanding any other provision of this Act, the 
applicant shall include in any application to the Secretary pursuant to 
this section appropriate information regarding the subject biological 
product stratified by gender, race, and ethnicity, including 
differences in safety and effectiveness.
    ``(ii) The Secretary shall develop standards that ensure that 
submissions to the Secretary pursuant to this section are adequately 
reviewed to determine whether such submissions include the information 
required under paragraph (D)(i).
    ``(iii) Upon the approval of an application under this subsection, 
the Secretary shall report to the scientific community and make 
available to the public, in a timely manner, data regarding such 
biological product stratified by gender, race, and ethnicity.''.
    (g) GAO Study.--Not later than 2 years after the date of enactment 
of this section, the Comptroller General of the United States shall 
study the drug approval processes of the Food and Drug Administration 
to ensure that the Food and Drug Administration is complying with the 
amendments made by this section.

SEC. 4. GENDER-BASED REPORTING AND ANALYSIS OF PATIENT SAFETY DATA.

    (a) Data Standards.--Section 923(b) of the Public Health Service 
Act (as amended by the Patient Safety and Quality Improvement Act of 
2005 (Public law 109-41)) is amended by adding at the end the 
following: ``The Secretary shall provide that all nonidentifiable 
patient safety work product reported to and among the network of 
patient safety databases be stratified by gender.''.
    (b) Use of Information.--Section 923(c) of the Public Health 
Service Act (as amended by the Patient Safety and Quality Improvement 
Act of 2005 (Public law 109-41)) is amended by adding at the end the 
following: ``Such analyses take into account data that specifically 
relates to women and any disparities between treatment and the quality 
of care between males and females.''.

SEC. 5. REPORTING OF HOSPITAL QUALITY DATA BY GENDER.

    Section 1886(b)(3)(B)(iv)(II) of the Social Security Act (42 U.S.C. 
1395ww(b)(3)(B)(vii)(II)), as amended by section 501 of the Medicare 
Prescription Drug, Improvement, and modernization Act of 2003 (Public 
law 108-173), is amended by adding at the end the following: ``The 
Secretary shall make such data available to the public, in a form and 
manner that stratifies the data by gender.''.

SEC. 6. QUALITY OF CARE REPORTS BY THE AGENCY FOR HEALTHCARE RESEARCH 
              AND QUALITY.

    Section 903 of the Public Health Service Act (42 U.S.C. 299a-1) is 
amended--
            (1) in subsection (b)(1)(B), by inserting before the 
        semicolon the following: ``, including quality of and access to 
        care for women with heart disease, stroke, and other 
        cardiovascular disease''; and
            (2) in subsection (c), by adding at the end the following:
            ``(4) Annual report on women and heart disease.--Not later 
        than September 30, 2006, and annually thereafter, the 
        Secretary, acting through the Director, shall prepare and 
        submit to Congress a report concerning the findings related to 
        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. 7. ANALYSIS OF DATA BY QUALITY IMPROVEMENT ORGANIZATIONS.

    Section 1154(a) of the Social Security Act (42 U.S.C. 1320c-3(a)) 
is amended by adding at the end the following:
            ``(18) The organization shall execute its responsibilities 
        under subparagraphs (A) and (B) of paragraph (1) by offering to 
        providers, practitioners, Medicare Advantage organizations 
        under part C, and prescription drug sponsors offering 
        prescription drug plans under part D quality improvement 
        assistance aimed at eliminating gender disparities in the 
        quality of care for women, particularly minority women, who 
        suffer from heart disease, stroke, and other cardiovascular 
        diseases. For purposes of this part and title XVIII, the 
        functions described in this paragraph shall be treated as a 
        review function.''.

SEC. 8. REPORTS BY ACCREDITING ORGANIZATIONS.

    The Social Security Act is amended by inserting after section 1808 
(42 U.S.C. 1395b-9) the following:

``SEC. 1809. STRATIFICATION OF DATA BY GENDER IN APPLYING CONDITIONS OF 
              PARTICIPATION AND CONDITIONS OF COVERAGE.

    ``The Secretary shall ensure that data are stratified by gender 
when collected and used in surveys evaluating whether providers meet 
the applicable conditions of participation or conditions of coverage 
under parts A, B, C, and D of this title. When determined feasible by 
the Secretary, such data shall be stratified by gender when reported to 
the public or otherwise made available to the public.''.

SEC. 9. EDUCATIONAL CAMPAIGNS.

    (a) Distribution of Educational Material Through the Center for 
Beneficiary Choices.--The Secretary of Health and Human Services, 
acting through the Center for Beneficiary Choices of the Centers for 
Medicare & Medicaid Services, shall develop and distribute to female 
medicare beneficiaries, physicians, and other appropriate healthcare 
professionals educational materials relating to the prevention, 
diagnosis, and treatment of heart disease, stroke, and cardiovascular 
diseases in women. The Center for Beneficiary Choices may carry out 
this subsection through contracts with public and private nonprofit 
entities.
    (b) Healthcare Professional Educational Campaign.--The Secretary of 
Health and Human Services, acting through the Bureau of Health 
Professions of the Health Resources and Services Administration, shall 
conduct an education and awareness campaign for physicians and other 
healthcare professionals relating to the prevention, diagnosis, and 
treatment of heart disease, stroke, and other cardiovascular diseases 
in women. The Bureau of Health Professions may carry out this 
subsection through contracts with public and private nonprofit 
entities.

SEC. 10. EXTENSION OF WISEWOMAN.

    There are authorized to be appropriated such sums as may be 
necessary for each fiscal year to enable the Director of the Centers 
for Disease Control and Prevention to implement Well-Integrated 
Screening and Evaluation for Women Across the Nation (WISEWOMAN) 
program projects in all State and territories, which may include 
projects among Indian tribes.
                                 <all>