I 

109TH CONGRESS 

1ST SESSION H. R. 3307

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. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 14, 2005

Ms. ROS-LEHTINEN (for herself, Mr. BISHOP of Georgia, Mr. BUTTERFIELD, 

Mrs. CHRISTENSEN, Mr. CLAY, Mr. CLEAVER, Mr. CONYERS, Mr. DAVIS

of Illinois, Mr. AL GREEN of Texas, Mr. HASTINGS of Florida, Ms. JACKSON-LEE of Texas, Mr. JEFFERSON, Mrs. JONES of Ohio, Ms. KILPATRICK of Michigan, Ms. LEE, Mr. MEEKS of New York, Ms. MOORE

of Wisconsin, Ms. NORTON, Mr. OWENS, Mr. RANGEL, Mr. RUSH, Mr. 

SCOTT of Virginia, Mr. THOMPSON of Mississippi, Ms. WATERS, Ms. 

WATSON, Mr. WYNN, Mr. WEXLER, Mr. ENGEL, Ms. WASSERMAN

SCHULTZ, Mr. LYNCH, Mr. MEEK of Florida, Mr. KILDEE, Ms. 

SCHAKOWSKY, Mr. HINCHEY, Mr. BRADY of Pennsylvania, Mr. TOWNS, 

Ms. CARSON, and Mr. FORD) 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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Lupus Research, Edu3 cation, Awareness, Communication, and Healthcare 

4 Amendments of 2005’’. 

5 SEC. 2. TABLE OF CONTENTS. 

6 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.

7 SEC. 3. FINDINGS. 

8 Congress makes the following findings: 

9 (1) Lupus is a serious, complex, debilitating 

10 autoimmune disease that can cause inflammation 

11 and tissue damage to virtually any organ system in 

12 the body, including the skin, joints, other connective 

13 tissue, blood and blood vessels, heart, lungs, kidney, 

14 and brain. 

15 (2) The Lupus Foundation of America, Inc. es16 timates that approximately 1,500,000 to 2,000,000 

17 Americans live with some form of lupus; lupus af18 fects women 9 times more often than men and 80 

19 percent of newly diagnosed cases of lupus develop 

20 among women of child-bearing age. 
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1 (3) Lupus disproportionately affects women of 

2 color; it is 2 to 3 times more common among Afri3 can-Americans, Hispanics, Asians, and Native Amer4 icans and is generally more prevalent in minority 

5 populations, a health disparity that remains unex6 plained. According to the Centers for Disease Con7 trol and Prevention, the rate of lupus mortality has 

8 increased since the late 1970s and is higher among 

9 older African-American women. 

10 (4) There have been no new drugs approved by 

11 the Food and Drug Administration specifically for 

12 lupus in nearly 40 years and while current treat13 ments for the disease can be effective, they can lead 

14 to damaging side effects. 

15 (5) The pain and fatigue associated with lupus 

16 can threaten people’s ability to live independently 

17 and make it difficult to maintain employment and 

18 lead normal lives. One in 5 people with lupus is dis19 abled by the disease, and consequently receives sup20 port from government programs, including medicare, 

21 medicaid, social security disability, and social secu22 rity supplemental income. 

23 (6) The estimated average annual cost of med24 ical treatment for an individual with lupus can range 

25 between $10,000 and $30,000; for people who have 
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1 the most serious form of lupus, medical costs can 

2 greatly exceed this amount, causing a significant 

3 economic, emotional, and social burden to the entire 

4 family and to society. 

(7) More than 1 5 ⁄2 of the people with lupus suf6 fer 4 or more years and visit 3 or more physicians 

7 before obtaining a diagnosis of lupus; early diagnosis 

8 of, and commencement of treatment for, lupus can 

9 prevent or reduce serious organ damage, disability, 

10 and death. 

11 (8) Despite the magnitude of lupus and its im12 pact on individuals and families, health professional 

13 and public understanding of lupus remains low; only 

14 1 of 5 Americans can provide even basic information 

15 about lupus, and awareness of lupus is lowest among 

16 adults ages 18 to 34, the age group most likely to 

17 develop symptoms of lupus. 

18 (9) Lupus is a significant national health issue 

19 that deserves a comprehensive and coordinated re20 sponse by Federal and State governments with the 

21 involvement of the healthcare provider, patient, and 

22 public health communities. 
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1 TITLE I—EXPANDING AND IM2 PROVING RESEARCH ON 

3 LUPUS 

4 SEC. 101. EXPANSION OF LUPUS BIOMEDICAL RESEARCH. 

5 Section 441A of the Public Health Service Act (42 

6 U.S.C. 285d–6a) is amended to read as follows: 

7 ‘‘EXPANSION OF LUPUS BIOMEDICAL RESEARCH

8 ‘‘SEC. 441A. (a) IN GENERAL.—The Secretary, act9 ing through the Director of the Institute, shall expand and 

10 intensify research and related activities of the Institute 

11 with respect to lupus. 

12 ‘‘(b) COORDINATION WITH OTHER INSTITUTES.—

13 The Director of the Institute shall coordinate the activities 

14 of the Director under subsection (a) with similar activities 

15 conducted by the other national research institutes and 

16 agencies of the National Institutes of Health to the extent 

17 that such institutes and agencies have responsibilities that 

18 are related to lupus. 

19 ‘‘(c) PROGRAMS FOR LUPUS.—In carrying out sub20 section (a), the Director of the Institute shall conduct or 

21 support research to expand the understanding of the 

22 causes of, and to find a cure for, lupus. Activities under 

23 such subsection shall include conducting and supporting 

24 the following: 
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1 ‘‘(1) Basic research to discover the pathogenesis 

2 and pathophysiology of the disease. 

3 ‘‘(2) Research to determine the reasons under4 lying the disproportionate prevalence of lupus in Af5 rican-American, Hispanic, Native American, and 

6 Asian women. 

7 ‘‘(3) Epidemiological studies to address the fre8 quency and natural history of the disease and the 

9 differences between the sexes and among racial and 

10 ethnic groups with respect to the disease. 

11 ‘‘(4) Clinical research for the development and 

12 evaluation of new treatments, including new biologi13 cal agents. 

14 ‘‘(5) Research to validate lupus biomarkers. 

15 ‘‘(6) Research to develop improved diagnostic 

16 tests.’’. 

17 SEC. 102. STRENGTHENING LUPUS EPIDEMIOLOGY; LUPUS 

18 STUDY. 

19 Part B of title III of the Public Health Service Act 

20 (42 U.S.C. 243 et seq.) is amended by inserting after sec21 tion 318B the following: 

22 ‘‘STRENGTHENING LUPUS EPIDEMIOLOGY

23 ‘‘SEC. 318C. (a) IN GENERAL.—The Secretary, act24 ing through the Director of the Centers for Disease Con25 trol and Prevention, shall work with a consortium of lead26 ing United States academic health institutions that have 
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1 expertise in the epidemiology of lupus to undertake a na2 tional scale lupus epidemiological study to determine the 

3 true prevalence and incidence of lupus in the United 

4 States. 

5 ‘‘(b) USE OF FUNDS.—The Director of the Centers 

6 for Disease Control and Prevention shall enter into a coop7 erative agreement with the consortium described in sub8 section (a) to develop, implement, and manage a system 

9 for lupus data collection and analysis, including—

10 ‘‘(1) the creation and use of a common data 

11 entry and management system across all study sites; 

12 and 

13 ‘‘(2) the enhancement of the 2 study sites in14 volved in the existing lupus patient registry of the 

15 Centers for Disease Control and Prevention on the 

16 day before the date of enactment of the Lupus Re17 search, Education, Awareness, Communication, and 

18 Healthcare Amendments of 2005. 

19 ‘‘(c) GEOGRAPHIC REPRESENTATION.—The Director 

20 of the Centers for Disease Control and Prevention shall 

21 ensure that the consortium described in subsection (a) 

22 represents different geographic regions of the United 

23 States that have a sufficient number of individuals of all 

24 racial and ethnic backgrounds disproportionately affected 
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1 by lupus, including Hispanics, Asians, Native Americans, 

2 and African-Americans. 

3 ‘‘(d) CERTAIN ACTIVITIES.—In carrying out sub4 sections (a) and (b), the consortium described in sub5 section (a) shall capture data related to all affected popu6 lations on all forms of lupus, including lupus related dis7 orders. 

8 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

9 are authorized to be appropriated to carry out this section 

10 $3,500,000 for each of the fiscal years 2006, 2007, 2008, 

11 and 2009. 

12 ‘‘LUPUS STUDY AND REPORT BY THE INSTITUTE OF

13 MEDICINE

14 ‘‘SEC. 318D. (a) CONTRACT.—The Secretary shall 

15 enter into a contract with the Institute of Medicine to con16 duct a study—

17 ‘‘(1) to evaluate the Federal and State activities 

18 related to lupus research, education, and awareness 

19 programs and activities and make recommendations 

20 for ways in which these initiatives could be ex21 panded; 

22 ‘‘(2) to identify the gaps in Federal research re23 lated to—

24 ‘‘(A) the causes of lupus; 

25 ‘‘(B) lupus detection and diagnosis; 

26 ‘‘(C) lupus treatment; and 
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1 ‘‘(D) lupus quality-of-life concerns; 

2 ‘‘(3) to make recommendations for building and 

3 supporting the lupus research enterprise, including 

4 recommendations for strategies for future basic, clin5 ical, social, and behavioral research—

6 ‘‘(A) to determine the pathophysiology and 

7 pathogenesis of the disease; and 

8 ‘‘(B) to secure the development of new and 

9 improved lupus therapies and ways to diagnose 

10 the disease; 

11 ‘‘(4) to determine the gaps in lupus health pro12 fessional education programs and public awareness 

13 efforts and make recommendations for ways in 

14 which the Federal Government can—

15 ‘‘(A) improve public and health profes16 sional awareness of lupus; and 

17 ‘‘(B) partner and support nonprofit vol18 untary health agencies (such as the Lupus 

19 Foundation of America, Inc.) and academic in20 stitutions and other interested stakeholders 

21 whose primary purposes are to increase public 

22 awareness of lupus and to improve the diag23 nosis and treatment of lupus; 

24 ‘‘(5) to make recommendations regarding ways 

25 to improve the quality of life for people with lupus; 
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1 ‘‘(6) to summarize the clinical and biological 

2 features of lupus and the characteristics and man3 agement of major symptoms and make recommenda4 tions for disease management and measurement; and 

5 ‘‘(7) to make recommendations for epidemiolog6 ical studies in the various population groups affected 

7 by lupus in the United States. 

8 ‘‘(b) REPORT.—Not later than 18 months after the 

9 date of enactment of the Lupus Research, Education, 

10 Awareness, Communication, and Healthcare Amendments 

11 of 2005, the Institute of Medicine shall submit to the Sec12 retary a report containing the information described in 

13 paragraphs (1) through (7) of subsection (a).’’. 

14 TITLE II—ENHANCING LUPUS 

15 AWARENESS AND EDUCATION 

16 SEC. 201. INCREASING PUBLIC AWARENESS AND IMPROV17 ING HEALTH PROFESSIONAL EDUCATION. 

18 Part B of title III of the Public Health Service Act 

19 (as amended by section 102) (42 U.S.C. 243 et seq.) is 

20 further amended by inserting after section 318D the fol21 lowing: 

22 ‘‘INCREASING PUBLIC AWARENESS OF LUPUS AND

23 IMPROVING HEALTH PROFESSIONAL EDUCATION

24 ‘‘SEC. 318E. (a) IN GENERAL.—The Secretary, act25 ing through the Director of the Office on Women’s Health 

26 and in collaboration with the Lupus Foundation of Amer-
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1 ica, Inc. and the National Center on Minority Health and 

2 Health Disparities of the National Institutes of Health, 

3 shall conduct and support a sustained national lupus pub4 lic awareness and health professional education campaign, 

5 with an emphasis on reaching populations at highest risk 

6 for the disease. 

7 ‘‘(b) USE OF FUNDS.—In conducting the sustained 

8 national lupus public awareness and health professional 

9 educational campaign, the Director of the Office on Wom10 en’s Health shall—

11 ‘‘(1) promote increased awareness of early 

12 intervention and treatment so as to significantly im13 prove the diagnosis, treatment, and quality of life for 

14 people with lupus; 

15 ‘‘(2) direct communication and education ef16 forts toward minority communities that may be un17 derserved or disproportionately affected by lupus; 

18 and 

19 ‘‘(3) target at-risk women and health profes20 sionals likely to see women with lupus, including pri21 mary care physicians and specialists such as 

22 rheumatologists, nephrologists, dermatologists, and 

23 immunologists, so as to help reduce the amount of 

24 time taken to achieve a correct diagnosis of lupus. 
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1 ‘‘(c) CERTAIN ACTIVITIES.—To the extent prac2 ticable and appropriate, the Secretary shall ensure that 

3 communications under subsections (a) and (b) provide the 

4 latest medically sound information related to the signs, 

5 symptoms, diagnosis, and disease management of lupus. 

6 ‘‘(d) INTEGRATION WITH OTHER PROGRAMS.—To 

7 the extent practicable and appropriate, the Secretary shall 

8 integrate efforts under this section with other programs 

9 carried out by the Secretary. 

10 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

11 are authorized to be appropriated to carry out this section 

12 $1,000,000 for each of the fiscal years 2006 through 

13 2010.’’.

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