I 

114TH CONGRESS 

1ST SESSION H. R. 2311 

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 

MAY 13, 2015 

Mr. SENSENBRENNER 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 2015’’. 

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 chronic or re6 curring symptoms in the GI tract including pain or 

7 discomfort, nausea, vomiting, diarrhea, constipation, 

8 incontinence, problems in the passage of food or 

9 feces, or a combination of these symptoms. 

10 (3) FGIMDs include conditions such as func11 tional dysphagia, gastroesophageal reflux disease, 

12 dyspepsia, cyclic vomiting syndrome, gallbladder and 

13 bile duct dysfunction, gastroparesis, irritable bowel 

14 syndrome (IBS), Hirschsprung’s disease, chronic in15 testinal pseudo-obstruction, bowel incontinence, and 

16 many others, which affect the esophagus, stomach, 

17 gallbladder, small and large intestine, and anorectal 

18 areas of the body. 

19 (4) The severity of FGIMDs ranges from mildly 

20 uncomfortable to debilitating and in some cases life21 threatening. 

22 (5) Effective treatments for the multiple symp23 toms of FGIMDs are lacking, and while sufferers 

24 frequently use a variety of medications and therapies 


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1 for symptoms, few patients report satisfaction with 

2 available treatments. 

3 (6) Physicians are not sufficiently educated on 

4 the proper diagnosis and up-to-date treatments for 

5 FGIMDs. This leads to excess health care costs due 

6 to unneeded diagnostic procedures and errors in 

7 treatments. 

8 (7) Patients with FGIMDs frequently suffer for 

9 years before receiving an accurate diagnosis, expos10 ing them to unnecessary and costly tests and proce11 dures including surgeries, as well as needless suf12 fering and expense. 

13 (8) The economic impact of FGIMDs is high. 

14 The annual cost in the United States for IBS alone 

15 is estimated to be between $1.7 billion and $10 bil16 lion in direct medical costs (excluding prescription 

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

18 indirect medical costs. 

19 (9) FGIMDs frequently take a toll on the work20 place, as reflected in work absenteeism, lost produc21 tivity, and lost opportunities for the individual and 

22 society. 

23 (10) Gastrointestinal symptoms consistent with 

24 functional gastrointestinal disorders, such as IBS 

25 and functional dyspepsia, are recognized as a serious 


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1 and disabling issue for military veterans, particularly 

2 those who have been deployed in war zones. 

3 (11) FGIMDs affect individuals of all ages in4 cluding children, and pediatric FGIMDs can be par5 ticularly serious, leading to a lifetime of painful 

6 symptoms and medical expenses associated with 

7 management of chronic illness or death. 

8 (12) There is inadequate public education and 

9 misunderstanding of FGIMDs leading to stigma 

10 placed upon individuals so afflicted. 

11 (13) The National Institutes of Health’s Na12 tional Commission on Digestive Diseases identified 

13 comprehensive research goals related to FGIMDs in 

14 its April 2009 report to Congress and the American 

15 public entitled ‘‘Opportunities and Challenges in Di16 gestive Diseases Research: Recommendations of the 

17 National Commission on Digestive Diseases’’. 

18 SEC. 3. FUNCTIONAL GASTROINTESTINAL AND MOTILITY 

19 DISORDERS RESEARCH ENHANCEMENT. 

20 Part B of the title IV of the Public Health Service 

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

22 end the following: 


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1 ‘‘SEC. 409K. FUNCTIONAL GASTROINTESTINAL AND MOTIL2 ITY DISORDERS. 

3 ‘‘The Director of NIH may expand, intensify, and co4 ordinate the activities of the National Institutes of Health 

5 with respect to functional gastrointestinal and motility dis6 orders (in this section referred to as ‘FGIMDs’) by— 

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

8 FGIMDs by implementing the research rec9 ommendations of the National Commission on Di10 gestive Diseases relating to FGIMDs; 

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

12 up to five centers of excellence on FGIMDs at lead13 ing academic medical centers throughout the country 

14 to carry out innovative basic, translational, and clin15 ical research focused on FGIMDs; 

16 ‘‘(3) supporting innovative approaches to edu17 cating health care providers and patients regarding 

18 strategies that improve patient-provider relationships 

19 and care and foster research to determine the effects 

20 of these approaches in improving patient satisfac21 tion, improved clinical outcomes, efficient utilization 

22 of health care services, and reduced health care 

23 costs; 

24 ‘‘(4) exploring collaborative research opportuni25 ties among the National Institute of Diabetes and 

26 Digestive and Kidney Diseases, the Office of ReVerDate Sep 11 2014 23:45 May 15, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2311.IH H2311

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1 search on Women’s Health, the Office of Rare Dis2 ease Research, and other Institutes and Centers of 

3 the National Institutes of Health; 

4 ‘‘(5) directing the National Institute of Diabe5 tes and Digestive and Kidney Diseases to provide 

6 the necessary funding for continued expansion and 

7 advancement of the FGIMDs research portfolio 

8 through intramural and extramural research; 

9 ‘‘(6) directing the National Institute of Diabe10 tes and Digestive and Kidney Diseases and the Eu11 nice Kennedy Shriver National Institute of Child 

12 Health and Human Development to expand research 

13 into FGIMDs that impact children, such as 

14 Hirschsprung’s disease and cyclic vomiting syn15 drome, and maternal health, such as fecal inconti16 nence; and 

17 ‘‘(7) exploring opportunities to partner with the 

18 Department of Defense and the Department of Vet19 erans Affairs to increase research and improve pa20 tient care regarding FGIMDs that commonly impact 

21 veterans and active duty military personnel, such as 

22 IBS and dyspepsia.’’. 


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1 SEC. 4. PROMOTING PUBLIC AWARENESS OF FUNCTIONAL 

2 GASTROINTESTINAL AND MOTILITY DIS3 ORDERS. 

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

5 (42 U.S.C. 243 et seq.) is amended by adding at the end 

6 the following: 

7 ‘‘SEC. 320B. PUBLIC AWARENESS OF FUNCTIONAL GASTRO8 INTESTINAL AND MOTILITY DISORDERS. 

9 ‘‘The Secretary may engage in public awareness and 

10 education activities to increase understanding and recogni11 tion of functional gastrointestinal and motility disorders 

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

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

14 materials targeting health care providers and the public 

15 and prepared and disseminated in conjunction with pa16 tient organizations that treat FGIMDs. The information 

17 expressed through such activities should emphasize— 

18 ‘‘(1) basic information on FGIMDs, their symp19 toms, prevalence, and frequently co-occurring condi20 tions; and 

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

22 prompt and accurate treatment of FGIMDs.’’. 


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1 SEC. 5. SENSE OF CONGRESS OF 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 and 

25 provider organizations that treat FGIMDs so that 


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1 the patient perspective is considered when deter2 mining the need for innovative treatments. 

Æ 


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