I 
110TH CONGRESS 
1ST SESSION H. R. 1192 
To amend the Public Health Service Act to enhance public and health profes-
sional awareness and understanding of lupus and to strengthen the 
Nation’s research efforts to identify the causes and cure of lupus. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 27, 2007 
Mr. MEEK of Florida (for himself, Ms. ROS-LEHTINEN, Mr. LEWIS of Geor-
gia, Mr. BRADY of Pennsylvania, Ms. JACKSON-LEE of Texas, and Mr. 
ORTIZ) introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Lupus Research, Edu-
cation, Awareness, Communication, and Healthcare 
Amendments of 2007’’. 
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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 edu-
cation. 
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. es-
timates that approximately 1,500,000 to 2,000,000 
Americans live with some form of lupus; lupus af-
fects 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 Afri-
can-Americans, Hispanics, Asians, and Native Amer-
icans and is generally more prevalent in minority 
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populations, a health disparity that remains unex-
plained. According to the Centers for Disease Con-
trol 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 treat-
ments 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 dis-
abled by the disease, and consequently receives sup-
port from government programs, including medicare, 
medicaid, social security disability, and social secu-
rity supplemental income. 
(6) The estimated average annual cost of med-
ical 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. 
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(7) More than 1⁄2 of the people with lupus suf-
fer 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 im-
pact 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 re-
sponse by Federal and State governments with the 
involvement of the healthcare provider, patient, and 
public health communities. 
TITLE I—EXPANDING AND IM-
PROVING 
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: 
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‘‘EXPANSION OF LUPUS BIOMEDICAL RESEARCH 
‘‘SEC. 441A. (a) IN GENERAL.—The Secretary, act-
ing 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 sub-
section (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 under-
lying the disproportionate prevalence of lupus in Af-
rican-American, Hispanic, Native American, and 
Asian women. 
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‘‘(3) Epidemiological studies to address the fre-
quency 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 biologi-
cal 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 sec-
tion 318B the following: 
‘‘STRENGTHENING LUPUS EPIDEMIOLOGY 
‘‘SEC. 318C. (a) IN GENERAL.—The Secretary, act-
ing through the Director of the Centers for Disease Con-
trol and Prevention, shall work with a consortium of lead-
ing United States academic health institutions that have 
expertise in the epidemiology of lupus to undertake a na-
tional 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 coop-
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erative agreement with the consortium described in sub-
section (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 in-
volved 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 Re-
search, Education, Awareness, Communication, and 
Healthcare Amendments of 2007. 
‘‘(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 sub-
sections (a) and (b), the consortium described in sub-
section (a) shall capture data related to all affected popu-
lations on all forms of lupus, including lupus related dis-
orders. 
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‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$3,500,000 for each of the fiscal years 2008, 2009, 2010, 
and 2011. 
‘‘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 con-
duct 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 ex-
panded; 
‘‘(2) to identify the gaps in Federal research re-
lated 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, clin-
ical, social, and behavioral research— 
‘‘(A) to determine the pathophysiology and 
pathogenesis of the disease; and 
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‘‘(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 pro-
fessional education programs and public awareness 
efforts and make recommendations for ways in 
which the Federal Government can— 
‘‘(A) improve public and health profes-
sional awareness of lupus; and 
‘‘(B) partner and support nonprofit vol-
untary health agencies (such as the Lupus 
Foundation of America, Inc.) and academic in-
stitutions and other interested stakeholders 
whose primary purposes are to increase public 
awareness of lupus and to improve the diag-
nosis 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 man-
agement of major symptoms and make recommenda-
tions for disease management and measurement; and 
‘‘(7) to make recommendations for epidemiolog-
ical studies in the various population groups affected 
by lupus in the United States. 
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‘‘(b) REPORT.—Not later than 18 months after the 
date of enactment of the Lupus Research, Education, 
Awareness, Communication, and Healthcare Amendments 
of 2007, the Institute of Medicine shall submit to the Sec-
retary 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 IMPROV-
ING 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 fol-
lowing: 
‘‘INCREASING PUBLIC AWARENESS OF LUPUS AND 
IMPROVING HEALTH PROFESSIONAL EDUCATION 
‘‘SEC. 318E. (a) IN GENERAL.—The Secretary, act-
ing through the Director of the Office on Women’s Health 
and in collaboration with the Lupus Foundation of Amer-
ica, 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 pub-
lic awareness and health professional education campaign, 
with an emphasis on reaching populations at highest risk 
for the disease. 
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