I 

113TH CONGRESS 

1ST SESSION H. R. 842 

To expand the research activities of the National Institutes of Health with 

respect to functional gastrointestinal and motility disorders, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 26, 2013 

Mr. SENSENBRENNER (for himself and Mr. MORAN) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To expand the research activities of the National Institutes 

of Health with respect to functional gastrointestinal and 

motility disorders, and for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Functional Gastro5 intestinal and Motility Disorders Research Enhancement 

6 Act of 2013’’. 

7 SEC. 2. FINDINGS. 

8 Congress finds the following: 


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1 (1) Functional gastrointestinal and motility dis2 orders (FGIMDs) are chronic conditions associated 

3 with increased sensitivity of the GI tract, abnormal 

4 motor functioning, and brain-gut dysfunction. 

5 (2) FGIMDs are characterized by symptoms in 

6 the GI tract including pain or discomfort, nausea, 

7 vomiting, diarrhea, constipation, incontinence, prob8 lems in the passage of food or feces, or a combina9 tion of these symptoms. 

10 (3) FGIMDs include conditions such as dys11 phagia, gastroesophageal reflux disease, dyspepsia, 

12 cyclic vomiting syndrome, gastroparesis, irritable 

13 bowel syndrome (IBS), Hirschsprung’s disease, 

14 chronic intestinal pseudo-obstruction, bowel inconti15 nence, and many others, which affect the esophagus, 

16 stomach, gallbladder, small and large intestine, and 

17 anorectal areas of the body. 

18 (4) The severity of FGIMDs ranges from mildly 

19 uncomfortable to debilitating and in some cases life20 threatening. 

21 (5) Effective treatments for the multiple symp22 toms of FGIMDs are lacking, and while sufferers 

23 frequently use a variety of medications and therapies 

24 for symptoms, few patients report satisfaction with 

25 available treatments. 


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1 (6) Patients with FGIMDs frequently suffer for 

2 years before receiving an accurate diagnosis, expos3 ing them to unnecessary and costly tests and proce4 dures including surgeries, as well as needless suf5 fering and expense. 

6 (7) The economic impact of FGIMDs is high. 

7 The annual cost in the United States for IBS alone 

8 is estimated to be between $1.7 billion and $10 bil9 lion in direct medical costs (excluding prescription 

10 and over-the-counter medications) and $20 billion in 

11 indirect medical costs. 

12 (8) FGIMDs frequently take a toll on the work13 place, as reflected in work absenteeism, lost produc14 tivity, and lost opportunities for the individual and 

15 society. 

16 (9) Gastrointestinal symptoms consistent with 

17 functional gastrointestinal disorders such as IBS 

18 and functional dyspepsia have been recognized as a 

19 serious and disabling issue for military veterans, 

20 particularly those who have been deployed. 

21 (10) FGIMDs affect individuals of all ages in22 cluding children, and pediatric FGIMDs can be par23 ticularly serious, leading to a lifetime of painful 

24 symptoms and medical expenses associated with 

25 management of chronic illness or death. 


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1 (11) The National Institutes of Health’s Na2 tional Commission on Digestive Diseases identified 

3 comprehensive research goals related to FGIMDs in 

4 its April 2009 report to Congress and the American 

5 public entitled ‘‘Opportunities and Challenges in Di6 gestive Diseases Research: Recommendations of the 

7 National Commission on Digestive Diseases’’. 

8 SEC. 3. FUNCTIONAL GASTROINTESTINAL AND MOTILITY 

9 DISORDERS RESEARCH ENHANCEMENT. 

10 Part B of title IV of the Public Health Service Act 

11 (42 U.S.C. 284 et seq.) is amended by adding at the end 

12 the following: 

13 ‘‘SEC. 409K. FUNCTIONAL GASTROINTESTINAL AND MOTIL14 ITY DISORDERS. 

15 ‘‘The Director of NIH may expand, intensify, and co16 ordinate the activities of the National Institutes of Health 

17 with respect to functional gastrointestinal and motility dis18 orders (in this section referred to as ‘FGIMDs’) by— 

19 ‘‘(1) expanding basic and clinical research into 

20 FGIMDs by implementing the research rec21 ommendations of the National Commission on Di22 gestive Diseases relating to FGIMDs; 

23 ‘‘(2) providing support for the establishment of 

24 up to five centers of excellence on FGIMDs at lead25 ing academic medical centers throughout the country 


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1 to carry out innovative basic, translational, and clin2 ical research focused on FGIMDs; 

3 ‘‘(3) exploring collaborative research opportuni4 ties among the National Institute of Diabetes and 

5 Digestive and Kidney Diseases, the Office of Re6 search on Women’s Health, the Office of Rare Dis7 ease Research, and other Institutes and Centers of 

8 the National Institutes of Health; 

9 ‘‘(4) directing the National Institute of Diabe10 tes and Digestive and Kidney Diseases to provide 

11 the necessary funding for continued expansion and 

12 advancement of the FGIMDs research portfolio 

13 through intramural and extramural research; 

14 ‘‘(5) directing the National Institute of Diabe15 tes and Digestive and Kidney Diseases and the Eu16 nice Kennedy Shriver National Institute of Child 

17 Health and Human Development to expand research 

18 into FGIMDs that impact children, such as 

19 Hirschsprung’s disease and cyclic vomiting syn20 drome, and maternal health, such as fecal inconti21 nence; and 

22 ‘‘(6) exploring opportunities to partner with the 

23 Department of Defense and the Department of Vet24 erans Affairs to increase research and improve pa25 tient care regarding FGIMDs that commonly impact 


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1 veterans and active duty military personnel, such as 

2 IBS and dyspepsia.’’. 

3 SEC. 4. PROMOTING PUBLIC AWARENESS OF FUNCTIONAL 

4 GASTROINTESTINAL AND MOTILITY DIS5 ORDERS. 

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

7 (42 U.S.C. 243 et seq.) is amended by adding at the end 

8 the following: 

9 ‘‘SEC. 320B. PUBLIC AWARENESS OF FUNCTIONAL GASTRO10 INTESTINAL AND MOTILITY DISORDERS. 

11 ‘‘The Secretary may engage in public awareness and 

12 education activities to increase understanding and recogni13 tion of functional gastrointestinal and motility disorders 

14 (in this section referred to as ‘FGIMDs’). Such activities 

15 may include the distribution of print, film, and web-based 

16 materials targeting health care providers and the public 

17 and prepared and disseminated in conjunction with pa18 tient organizations that treat FGIMDs. The information 

19 expressed through such activites should emphasize— 

20 ‘‘(1) basic information on FGIMDs, their symp21 toms, prevalence, and frequently co-occurring condi22 tions; and 

23 ‘‘(2) the importance of early diagnosis, and 

24 prompt and accurate treatment of FGIMDs.’’. 


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1 SEC. 5. SENSE OF CONGRESS ON THE DEVELOPMENT AND 

2 OVERSIGHT OF INNOVATIVE TREATMENT OP3 TIONS FOR FUNCTIONAL GASTROINTESTINAL 

4 AND MOTILITY DISORDERS. 

5 It is the sense of Congress that, considering the cur6 rent lack of effective treatment options for the global 

7 symptoms of functional gastrointestinal and motility dis8 orders (in this section referred to as ‘‘FGIMDs’’) and the 

9 inherent challenges of developing and bringing such treat10 ments to market, the Commissioner of Food and Drugs 

11 should continue and accelerate important efforts to im12 prove the development and oversight of treatment options 

13 for FGIMDs by— 

14 (1) enhancing the commitment to emerging ef15 forts like the Patient Reported Outcomes Consor16 tium to expedite medical device and drug develop17 ment, study appropriate balances between risk and 

18 patient benefit, and identify proper endpoints for 

19 conditions without clear, biological indicators; 

20 (2) enhancing the commitment to broad efforts 

21 like the Critical Path Initiative focused on ensuring 

22 that scientific breakthroughs are quickly translated 

23 into safe and beneficial treatment options; and 

24 (3) continuing collaboration with patient orga25 nizations that treat FGIMDs so that the patient 


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1 perspective is considered when determining the need 

2 for innovative treatments. 

Æ 


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