A bill to amend the Public Health Service Act to enhance public and health professional awareness and understanding of lupus and to strengthen the Nation's research efforts to identify the causes and cure of lupus.

Summary: Lupus Research, Education, Awareness, Communication, and Healthcare Amendments of 2005 - Amends the Public Health Service Act to require the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases to expand research on lupus to include: (1) basic research to discover the pathogenesis and pathophysiology of the disease; and (2) research to validate lupus biomarkers.

Requires the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to work with a consortium of academic health institutions to undertake an epidemiological study to determine the prevalence and incidence of lupus in the United States. Requires the Director of CDC to: (1) enter into a cooperative agreement with such consortium to develop, implement, and manage a system for lupus data collection and analysis; and (2) ensure that such consortium represents different geographic areas and includes individuals of racial and ethnic backgrounds disproportionately affected by lupus.

Requires the Secretary to enter into a contract with the Institute of Medicine to study and make recommendations related to lupus, to include: (1) evaluating Federal and State activities related to lupus and recommending ways to expand such activities; (2) identifying gaps in Federal research; and (3) recommending ways to improve the quality of life for people with lupus.

Requires the Secretary, acting through the Director of the Office on Women's Health, to conduct and support a national lupus public awareness and health professional education campaign, with an emphasis on reaching populations at highest risk for the disease.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Lupus Research, Education, 
Awareness, Communication, and Healthcare Amendments of 2005''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Findings.
           TITLE I--EXPANDING AND IMPROVING RESEARCH ON LUPUS

Sec. 101. Expansion of lupus biomedical research.
Sec. 102. Strengthening lupus epidemiology; lupus study.
           TITLE II--ENHANCING LUPUS AWARENESS AND EDUCATION

Sec. 201. Increasing public awareness and improving health professional 
                            education.

SEC. 3. FINDINGS.

    Congress makes the following findings:
            (1) Lupus is a serious, complex, debilitating autoimmune 
        disease that can cause inflammation and tissue damage to 
        virtually any organ system in the body, including the skin, 
        joints, other connective tissue, blood and blood vessels, 
        heart, lungs, kidney, and brain.
            (2) The Lupus Foundation of America, Inc. estimates that 
        approximately 1,500,000 to 2,000,000 Americans live with some 
        form of lupus; lupus affects women 9 times more often than men 
        and 80 percent of newly diagnosed cases of lupus develop among 
        women of child-bearing age.
            (3) Lupus disproportionately affects women of color; it is 
        2 to 3 times more common among African-Americans, Hispanics, 
        Asians, and Native Americans and is generally more prevalent in 
        minority populations, a health disparity that remains 
        unexplained. According to the Centers for Disease Control and 
        Prevention, the rate of lupus mortality has increased since the 
        late 1970s and is higher among older African-American women.
            (4) There have been no new drugs approved by the Food and 
        Drug Administration specifically for lupus in nearly 40 years 
        and while current treatments for the disease can be effective, 
        they can lead to damaging side effects.
            (5) The pain and fatigue associated with lupus can threaten 
        people's ability to live independently and make it difficult to 
        maintain employment and lead normal lives. One in 5 people with 
        lupus is disabled by the disease, and consequently receives 
        support from government programs, including medicare, medicaid, 
        social security disability, and social security supplemental 
        income.
            (6) The estimated average annual cost of medical treatment 
        for an individual with lupus can range between $10,000 and 
        $30,000; for people who have the most serious form of lupus, 
        medical costs can greatly exceed this amount, causing a 
        significant economic, emotional, and social burden to the 
        entire family and to society.
            (7) More than \1/2\ of the people with lupus suffer 4 or 
        more years and visit 3 or more physicians before obtaining a 
        diagnosis of lupus; early diagnosis of, and commencement of 
        treatment for, lupus can prevent or reduce serious organ 
        damage, disability, and death.
            (8) Despite the magnitude of lupus and its impact on 
        individuals and families, health professional and public 
        understanding of lupus remains low; only 1 of 5 Americans can 
        provide even basic information about lupus, and awareness of 
        lupus is lowest among adults ages 18 to 34, the age group most 
        likely to develop symptoms of lupus.
            (9) Lupus is a significant national health issue that 
        deserves a comprehensive and coordinated response by Federal 
        and State governments with the involvement of the healthcare 
        provider, patient, and public health communities.

           TITLE I--EXPANDING AND IMPROVING RESEARCH ON LUPUS

SEC. 101. EXPANSION OF LUPUS BIOMEDICAL RESEARCH.

    Section 441A of the Public Health Service Act (42 U.S.C. 285d-6a) 
is amended to read as follows:

                ``expansion of lupus biomedical research

    ``Sec. 441A. (a) In General.--The Secretary, acting through the 
Director of the Institute, shall expand and intensify research and 
related activities of the Institute with respect to lupus.
    ``(b) Coordination With Other Institutes.--The Director of the 
Institute shall coordinate the activities of the Director under 
subsection (a) with similar activities conducted by the other national 
research institutes and agencies of the National Institutes of Health 
to the extent that such institutes and agencies have responsibilities 
that are related to lupus.
    ``(c) Programs for Lupus.--In carrying out subsection (a), the 
Director of the Institute shall conduct or support research to expand 
the understanding of the causes of, and to find a cure for, lupus. 
Activities under such subsection shall include conducting and 
supporting the following:
            ``(1) Basic research to discover the pathogenesis and 
        pathophysiology of the disease.
            ``(2) Research to determine the reasons underlying the 
        disproportionate prevalence of lupus in African-American, 
        Hispanic, Native American, and Asian women.
            ``(3) Epidemiological studies to address the frequency and 
        natural history of the disease and the differences between the 
        sexes and among racial and ethnic groups with respect to the 
        disease.
            ``(4) Clinical research for the development and evaluation 
        of new treatments, including new biological agents.
            ``(5) Research to validate lupus biomarkers.
            ``(6) Research to develop improved diagnostic tests.''.

SEC. 102. STRENGTHENING LUPUS EPIDEMIOLOGY; LUPUS STUDY.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 318B the following:

                   ``strengthening lupus epidemiology

    ``Sec. 318C. (a) In General.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, shall work 
with a consortium of leading United States academic health institutions 
that have expertise in the epidemiology of lupus to undertake a 
national scale lupus epidemiological study to determine the true 
prevalence and incidence of lupus in the United States.
    ``(b) Use of Funds.--The Director of the Centers for Disease 
Control and Prevention shall enter into a cooperative agreement with 
the consortium described in subsection (a) to develop, implement, and 
manage a system for lupus data collection and analysis, including--
            ``(1) the creation and use of a common data entry and 
        management system across all study sites; and
            ``(2) the enhancement of the 2 study sites involved in the 
        existing lupus patient registry of the Centers for Disease 
        Control and Prevention on the day before the date of enactment 
        of the Lupus Research, Education, Awareness, Communication, and 
        Healthcare Amendments of 2005.
    ``(c) Geographic Representation.--The Director of the Centers for 
Disease Control and Prevention shall ensure that the consortium 
described in subsection (a) represents different geographic regions of 
the United States that have a sufficient number of individuals of all 
racial and ethnic backgrounds disproportionately affected by lupus, 
including Hispanics, Asians, Native Americans, and African-Americans.
    ``(d) Certain Activities.--In carrying out subsections (a) and (b), 
the consortium described in subsection (a) shall capture data related 
to all affected populations on all forms of lupus, including lupus 
related disorders.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $3,500,000 for each of the 
fiscal years 2006, 2007, 2008, and 2009.

         ``lupus study and report by the institute of medicine

    ``Sec. 318D. (a) Contract.--The Secretary shall enter into a 
contract with the Institute of Medicine to conduct a study--
            ``(1) to evaluate the Federal and State activities related 
        to lupus research, education, and awareness programs and 
        activities and make recommendations for ways in which these 
        initiatives could be expanded;
            ``(2) to identify the gaps in Federal research related to--
                    ``(A) the causes of lupus;
                    ``(B) lupus detection and diagnosis;
                    ``(C) lupus treatment; and
                    ``(D) lupus quality-of-life concerns;
            ``(3) to make recommendations for building and supporting 
        the lupus research enterprise, including recommendations for 
        strategies for future basic, clinical, social, and behavioral 
        research--
                    ``(A) to determine the pathophysiology and 
                pathogenesis of the disease; and
                    ``(B) to secure the development of new and improved 
                lupus therapies and ways to diagnose the disease;
            ``(4) to determine the gaps in lupus health professional 
        education programs and public awareness efforts and make 
        recommendations for ways in which the Federal Government can--
                    ``(A) improve public and health professional 
                awareness of lupus; and
                    ``(B) partner and support nonprofit voluntary 
                health agencies (such as the Lupus Foundation of 
                America, Inc.) and academic institutions and other 
                interested stakeholders whose primary purposes are to 
                increase public awareness of lupus and to improve the 
                diagnosis and treatment of lupus;
            ``(5) to make recommendations regarding ways to improve the 
        quality of life for people with lupus;
            ``(6) to summarize the clinical and biological features of 
        lupus and the characteristics and management of major symptoms 
        and make recommendations for disease management and 
        measurement; and
            ``(7) to make recommendations for epidemiological studies 
        in the various population groups affected by lupus in the 
        United States.
    ``(b) Report.--Not later than 18 months after the date of enactment 
of the Lupus Research, Education, Awareness, Communication, and 
Healthcare Amendments of 2005, the Institute of Medicine shall submit 
to the Secretary a report containing the information described in 
paragraphs (1) through (7) of subsection (a).''.

           TITLE II--ENHANCING LUPUS AWARENESS AND EDUCATION

SEC. 201. INCREASING PUBLIC AWARENESS AND IMPROVING HEALTH PROFESSIONAL 
              EDUCATION.

    Part B of title III of the Public Health Service Act (as amended by 
section 102) (42 U.S.C. 243 et seq.) is further amended by inserting 
after section 318D the following:

      ``increasing public awareness of lupus and improving health 
                         professional education

    ``Sec. 318E. (a) In General.--The Secretary, acting through the 
Director of the Office on Women's Health and in collaboration with the 
Lupus Foundation of America, Inc. and the National Center on Minority 
Health and Health Disparities of the National Institutes of Health, 
shall conduct and support a sustained national lupus public awareness 
and health professional education campaign, with an emphasis on 
reaching populations at highest risk for the disease.
    ``(b) Use of Funds.--In conducting the sustained national lupus 
public awareness and health professional educational campaign, the 
Director of the Office on Women's Health shall--
            ``(1) promote increased awareness of early intervention and 
        treatment so as to significantly improve the diagnosis, 
        treatment, and quality of life for people with lupus;
            ``(2) direct communication and education efforts toward 
        minority communities that may be underserved or 
        disproportionately affected by lupus; and
            ``(3) target at-risk women and health professionals likely 
        to see women with lupus, including primary care physicians and 
        specialists such as rheumatologists, nephrologists, 
        dermatologists, and immunologists, so as to help reduce the 
        amount of time taken to achieve a correct diagnosis of lupus.
    ``(c) Certain Activities.--To the extent practicable and 
appropriate, the Secretary shall ensure that communications under 
subsections (a) and (b) provide the latest medically sound information 
related to the signs, symptoms, diagnosis, and disease management of 
lupus.
    ``(d) Integration With Other Programs.--To the extent practicable 
and appropriate, the Secretary shall integrate efforts under this 
section with other programs carried out by the Secretary.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $1,000,000 for each of the 
fiscal years 2006 through 2010.''.