II 111th CONGRESS 1st Session S. 981 IN THE SENATE OF THE UNITED STATES May 5, 2009 Mr. Reid introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To support research and public awareness activities with respect to inflammatory bowel disease, and for other purposes.

1.

Short title

This Act may be cited as the Inflammatory Bowel Disease Research and Awareness Act.

2.

Findings

Congress finds the following: (1)Crohn's disease and ulcerative colitis are serious inflammatory diseases of the gastrointestinal tract. (2)Crohn's disease may occur in any section of the gastrointestinal tract but is predominately found in the lower part of the small intestine and the large intestine. Ulcerative colitis is characterized by inflammation and ulceration of the innermost lining of the colon. Complete removal of the colon in patients with ulcerative colitis can potentially alleviate and cure symptoms. (3)Because Crohn's disease and ulcerative colitis behave similarly, they are collectively known as inflammatory bowel disease. Both diseases present a variety of symptoms, including severe diarrhea, abdominal pain with cramps, fever, arthritic joint pain, inflammation of the eye, and rectal bleeding. There is no known cause of inflammatory bowel disease, or medical cure. (4)It is estimated that up to 1,400,000 people in the United States suffer from inflammatory bowel disease, 30 percent of whom are diagnosed during their childhood years. (5)Children with inflammatory bowel disease miss school activities because of bloody diarrhea and abdominal pain, and many adults who had onset of inflammatory bowel disease as children had delayed puberty and impaired growth and have never reached their full genetic growth potential. (6)Inflammatory bowel disease patients are at high risk for developing colorectal cancer. (7)The total annual medical costs for inflammatory bowel disease patients are estimated at more than $2,000,000,000. (8)The average time from presentation of symptoms to diagnosis in children is 3 years. (9)Delayed diagnosis of inflammatory bowel disease frequently results in more-active disease associated with increased morbidity and complications. (10)Congress has appropriated $3,480,000 from fiscal year 2005 to fiscal year 2009 for epidemiology research on inflammatory bowel disease through the Centers for Disease Control and Prevention. (11)The National Institutes of Health National Commission on Digestive Diseases issued comprehensive research goals related to inflammatory bowel disease in its April 2009 report to Congress and the American public entitled; Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases.

3.

Enhancing public health activities on inflammatory bowel disease at the centers for disease control and prevention

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 320A the following:

320B.

Inflammatory bowel disease epidemiology program

(a)

In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall conduct, support and expand existing epidemiology research on inflammatory bowel disease in both pediatric and adult populations. (b)

Grants

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants to, and enter into contracts and cooperative agreements with, a patient or medical organization with expertise in conducting inflammatory bowel disease research to develop and administer the epidemiology program. (c)

Rule of construction

Nothing in this section shall be construed to limit the authority of the Centers for Disease Control and Prevention to support a pediatric inflammatory bowel disease patient registry. (d)

Authorization of appropriations

There are authorized to be appropriated to carry out this section, $1,500,000 for each of the fiscal years 2010 through 2014.

320C.

Increasing public awareness of inflammatory bowel disease and improving health professional education

(a)

In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to eligible entities for the purpose of increasing awareness of inflammatory bowel disease among the general public and health care providers. (b)

Use of funds

An eligible entity shall use grant funds under this section to develop educational materials and conduct awareness programs focused on the following subjects: (1)Crohn’s disease and ulcerative colitis, and their symptoms. (2)Testing required for appropriate diagnosis, and the importance of accurate and early diagnosis. (3)Key differences between pediatric and adult disease. (4)Specific physical and psychosocial issues impacting pediatric patients, including stunted growth, malnutrition, delayed puberty, and depression. (5)Treatment options for both adult and pediatric patients. (6)The importance of identifying aggressive disease in children at an early stage in order to implement the most effective treatment protocol. (7)Complications of inflammatory bowel disease and related secondary conditions, including colorectal cancer. (8)Federal and private information resources for patients and physicians. (9)Incidence and prevalence data on pediatric and adult inflammatory bowel disease. (c)

Eligible entity

For purposes of this section, the term eligible entity means a patient or medical organization with experience in serving adults and children with inflammatory bowel disease. (d)

Report to Congress

Not later than September 30, 2010, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Appropriations of the House of Representatives and the Senate, a report regarding the status of activities carried out under this section. (e)

Authorization of appropriations

For the purpose of carrying out this section, there is authorized to be appropriated such sums as may be necessary for each of fiscal years 2010 through 2014.

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4.

Expansion of biomedical research on inflammatory bowel disease

(a)

Sense of Congress

It is the sense of Congress that— (1)the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health and the Director of the National Institute of Diabetes and Digestive and Kidney Diseases (in this section referred to as the Institute), should aggressively support basic, translational, and clinical research designed to meet the research goals for inflammatory bowel disease included in the National Institutes of Health National Commission on Digestive Diseases report entitled Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases, which shall include— (A)establishing an objective basis for determining clinical diagnosis, detailed phenotype, and disease activity in inflammatory bowel disease; (B)developing an individualized approach to inflammatory bowel disease risk evaluation and management based on genetic susceptibility; (C)modulating the intestinal microflora to prevent or control inflammatory bowel disease; (D)effectively modulating the mucosal immune system to prevent or ameliorate inflammatory bowel disease; (E)sustaining the health of the mucosal surface; (F)promoting regeneration and repair of injury in inflammatory bowel disease; (G)providing effective tools for clinical evaluation and intervention in inflammatory bowel disease; and (H)ameliorating or preventing adverse effects of inflammatory bowel disease on growth and development in children and adolescents; (2)the Institute should support the training of qualified health professionals in biomedical research focused on inflammatory bowel disease, including pediatric investigators; and (3)the Institute should continue its strong collaboration with medical and patient organizations concerned with inflammatory bowel disease and seek opportunities to promote research identified in the scientific agendas Challenges in Inflammatory Bowel Disease Research (Crohn's and Colitis Foundation of America) and Chronic Inflammatory Bowel Disease (North American Society for Pediatric Gastroenterology, Hepatology and Nutrition). (b)

Biennial reports

As part of the biennial report submitted under section 403 of the Public Health Service Act (42 U.S.C. 283), the Secretary of Health and Human Services shall include information on the status of inflammatory bowel disease research at the National Institutes of Health.