A bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.

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, Native American, and some Asian 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 healthcare 
        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 in 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 differences in the 
        effects, diagnosis, and treatment of stroke depending on the 
        sex of the patient. 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 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:
    ``(6)(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 
sex, 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 sex, 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 sex, 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 sex, race, and ethnicity 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 sex, 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 sex, 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.
    ``(C) 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 sex, 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 sex, 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 (2)--
                            (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 sex, 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 sex, 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 subparagraph (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 sex, 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 clause (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 sex, 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. REPORTING AND ANALYSIS OF PATIENT SAFETY DATA.

    (a) Data Standards.--Section 923(b) of the Public Health Service 
Act (42 U.S.C. 299b-23(b)) 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 sex.''.
    (b) Use of Information.--Section 923(c) of the Public Health 
Service Act (42 U.S.C. 299b-23(c)) 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. 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 diseases''; 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, 2007, 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. 6. EDUCATIONAL CAMPAIGNS.

    (a) Distribution of Educational Material.--The Secretary of Health 
and Human Services (referred to in this section as the ``Secretary'') 
shall develop and distribute to females who are age 65 or older, 
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 Secretary 
may carry out this subsection through contracts with public and private 
nonprofit entities.
    (b) Healthcare Professional Educational Campaign.--The Secretary, 
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. 7. 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 States and territories, which may include 
projects among Indian tribes.

Summary: Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require an application for approval or for investigation of a drug, device, or biological product to include information stratified by sex, race, and ethnicity, including any differences in safety and effectiveness. Requires the Secretary of Health and Human Services to: (1) withhold approval of such an application or place a clinical hold on an investigation if such information is not included. And (2) report to the scientific community and make information available to the public on such stratified data upon approval of an application. Requires the Comptroller General to study the drug approval process to ensure compliance with this Act. Requires the Secretary to require that all nonidentifiable patient safety work product reported to a patient safety database be stratified by sex. Requires the Secretary, acting through the Director of the Agency for Healthcare Research and Quality (AHRQ), to report to Congress concerning the quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases. Provides for an educational campaign relating to heart disease, stroke, and cardiovascular diseases in women. Authorizes appropriations 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 states and territories.