I 

116TH CONGRESS 

1ST SESSION H. R. 3396 

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 

JUNE 20, 2019 

Mr. SENSENBRENNER (for himself and Ms. MOORE) 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 2019’’. 

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 both common and rare 

11 conditions, such as functional dysphagia, 

12 gastroesophageal reflux disease, dyspepsia, cyclic 

13 vomiting syndrome, gallbladder and bile duct dys14 function, gastroparesis, irritable bowel syndrome 

15 (IBS), Hirschsprung’s disease, chronic intestinal 

16 pseudo-obstruction, bowel incontinence, opioid in17 duced GI hyperalgesia, abdomino-phrenic 

18 dyssynergia (APD), and many others, which affect 

19 the esophagus, stomach, gallbladder, small and large 

20 intestine, and anorectal areas of the body. 

21 (4) The severity of FGIMDs ranges from mildly 

22 uncomfortable to debilitating and in some cases can 

23 be life-threatening. 

24 (5) Effective treatments for the multiple symp25 toms of FGIMDs are lacking, and while sufferers 


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1 frequently use a variety of medications and therapies 

2 for symptoms, few patients report satisfaction with 

3 available treatments. 

4 (6) Physicians are not sufficiently educated on 

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

6 FGIMDs. This leads to excess health care costs due 

7 to unneeded diagnostic procedures and errors in 

8 treatments. 

9 (7) Frequently there is a need for a multidisci10 plinary care approach to patients with FGIMDs, in11 cluding access to nutritional and mental health sup12 port to improve pain management and facilitate pa13 tient and parent understanding of the brain-gut axis 

14 and overall patient functioning. 

15 (8) Patients with FGIMDs frequently suffer for 

16 years before receiving an accurate diagnosis, expos17 ing them to unnecessary and costly tests and proce18 dures including surgeries, as well as needless suf19 fering and expense. 

20 (9) The economic impact of FGIMDs is high. 

21 The annual cost in the United States for IBS alone 

22 is estimated to be between $1.7 billion and $10 bil23 lion in direct medical costs (excluding prescription 

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

25 indirect medical costs. 


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1 (10) FGIMDs frequently take a toll on the 

2 workplace, as reflected in work absenteeism, lost 

3 productivity, and lost opportunities for the individual 

4 and society. 

5 (11) Gastrointestinal symptoms consistent with 

6 functional gastrointestinal disorders, such as IBS 

7 and functional dyspepsia, are recognized as a serious 

8 and disabling issue for military veterans, particularly 

9 those who have been deployed in war zones and ex10 perience posttraumatic stress disorder. 

11 (12) FGIMDs affect individuals of all ages in12 cluding children, and pediatric FGIMDs can be par13 ticularly serious, leading to a lifetime of painful 

14 symptoms and medical expenses associated with 

15 management of chronic illness or death, as well as 

16 missed school days and homebound instruction. 

17 (13) There is inadequate public education and 

18 misunderstanding of FGIMDs leading to stigma 

19 placed upon individuals so afflicted. 

20 (14) The National Institutes of Health’s Na21 tional Commission on Digestive Diseases identified 

22 comprehensive research goals related to FGIMDs in 

23 its April 2009 report to Congress and the American 

24 public entitled ‘‘Opportunities and Challenges in DiVerDate Sep 11 2014 23:19 Jun 26, 2019 Jkt 034408 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3396.IH H3396

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1 gestive Diseases Research: Recommendations of the 

2 National Commission on Digestive Diseases’’. 

3 SEC. 3. FUNCTIONAL GASTROINTESTINAL AND MOTILITY 

4 DISORDERS RESEARCH ENHANCEMENT. 

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

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

7 end the following: 

8 ‘‘SEC. 409K. FUNCTIONAL GASTROINTESTINAL AND MOTIL9 ITY DISORDERS. 

10 ‘‘The Director of NIH may expand, intensify, and co11 ordinate the activities of the National Institutes of Health 

12 with respect to functional gastrointestinal and motility dis13 orders (in this section referred to as ‘FGIMDs’) by— 

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

15 FGIMDs by implementing the research rec16 ommendations of the National Commission on Di17 gestive Diseases relating to FGIMDs; 

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

19 up to 5 centers of excellence on FGIMDs at leading 

20 academic medical centers throughout the country to 

21 carry out innovative basic, translational, and clinical 

22 research focused on FGIMDs in both pediatric and 

23 adult patients; 

24 ‘‘(3) supporting innovative approaches to edu25 cating health care providers and patients regarding 


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1 strategies that improve patient-provider relationships 

2 and care and foster research to determine the effects 

3 of these approaches in improving patient satisfac4 tion, improved clinical outcomes, efficient utilization 

5 of health care services, and reduced health care 

6 costs; 

7 ‘‘(4) exploring collaborative research opportuni8 ties among the National Institute of Diabetes and 

9 Digestive and Kidney Diseases, the Office of Re10 search on Women’s Health, the Office of Rare Dis11 eases, the National Institute of Mental Health, and 

12 other institutes and centers of the National Insti13 tutes of Health; 

14 ‘‘(5) directing the National Institute of Diabe15 tes and Digestive and Kidney Diseases to provide 

16 the necessary funding for continued expansion and 

17 advancement of the FGIMDs research portfolio 

18 through intramural and extramural research; 

19 ‘‘(6) directing the National Institute of Diabe20 tes and Digestive and Kidney Diseases and the Eu21 nice Kennedy Shriver National Institute of Child 

22 Health and Human Development to expand research 

23 into FGIMDs that impact children, such as 

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1 drome, and maternal health, such as fecal inconti2 nence; and 

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

4 Department of Defense and the Department of Vet5 erans Affairs to increase research and improve pa6 tient care regarding FGIMDs that commonly impact 

7 veterans and active duty military personnel, such as 

8 IBS and dyspepsia.’’. 

9 SEC. 4. PROMOTING PUBLIC AWARENESS OF FUNCTIONAL 

10 GASTROINTESTINAL AND MOTILITY DIS11 ORDERS. 

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

13 (42 U.S.C. 243 et seq.) is amended by adding at the end 

14 the following: 

15 ‘‘SEC. 320B. PUBLIC AWARENESS OF FUNCTIONAL GASTRO16 INTESTINAL AND MOTILITY DISORDERS. 

17 ‘‘The Secretary may engage in public awareness and 

18 education activities to increase understanding and recogni19 tion of functional gastrointestinal and motility disorders 

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

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

22 materials targeting health care providers and the public 

23 and prepared and disseminated in conjunction with pa24 tient organizations that treat FGIMDs. The information 

25 expressed through such activities should emphasize— 


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1 ‘‘(1) basic information on FGIMDs, their symp2 toms, prevalence, and frequently co-occurring condi3 tions; and 

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

5 prompt and accurate treatment of FGIMDs, includ6 ing access to nutritional and mental health sup7 port.’’. 

8 SEC. 5. SENSE OF CONGRESS OF THE DEVELOPMENT AND 

9 OVERSIGHT OF INNOVATIVE TREATMENT OP10 TIONS FOR FUNCTIONAL GASTROINTESTINAL 

11 AND MOTILITY DISORDERS. 

12 It is the sense of Congress that, considering the cur13 rent lack of effective treatment options for the global 

14 symptoms of functional gastrointestinal and motility dis15 orders (in this section referred to as ‘‘FGIMDs’’) and the 

16 inherent challenges of developing and bringing such treat17 ments to market, the Commissioner of Food and Drugs 

18 should continue and accelerate important efforts to im19 prove the development and oversight of treatment options 

20 for FGIMDs by— 

21 (1) enhancing the commitment to emerging ef22 forts like the Patient Reported Outcomes Consor23 tium to expedite medical device and drug develop24 ment, the study of appropriate balances between risk 

25 and patient benefit, and identification of proper 


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1 endpoints for conditions without clear, biological in2 dicators; 

3 (2) enhancing the commitment to broad efforts 

4 like the Critical Path Initiative focused on ensuring 

5 that scientific breakthroughs are quickly translated 

6 into safe and beneficial treatment options for both 

7 pediatric and adult patients; and 

8 (3) continuing collaboration with patient and 

9 provider organizations that treat FGIMDs so that 

10 the patient perspective is considered when deter11 mining the need for innovative treatments. 

Æ 


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