Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2019

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Functional Gastro- 4 intestinal and Motility Disorders Research Enhancement 5 Act of 2019’’. 6 SEC. 2. FINDINGS. 7 Congress finds the following: 8 VerDate Sep 11 2014 23:19 Jun 26, 2019 Jkt 034408 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3396.IH H3396 pbinns on DSK79D2C42PROD with BILLS 2 •HR 3396 IH (1) Functional gastrointestinal and motility dis- 1 orders (FGIMDs) are chronic conditions associated 2 with increased sensitivity of the GI tract, abnormal 3 motor functioning, and brain-gut dysfunction. 4 (2) FGIMDs are characterized by chronic or re- 5 curring symptoms in the GI tract including pain or 6 discomfort, nausea, vomiting, diarrhea, constipation, 7 incontinence, problems in the passage of food or 8 feces, or a combination of these symptoms. 9 (3) FGIMDs include both common and rare 10 conditions, such as functional dysphagia, 11 gastroesophageal reflux disease, dyspepsia, cyclic 12 vomiting syndrome, gallbladder and bile duct dys- 13 function, gastroparesis, irritable bowel syndrome 14 (IBS), Hirschsprung’s disease, chronic intestinal 15 pseudo-obstruction, bowel incontinence, opioid in- 16 duced GI hyperalgesia, abdomino-phrenic 17 dyssynergia (APD), and many others, which affect 18 the esophagus, stomach, gallbladder, small and large 19 intestine, and anorectal areas of the body. 20 (4) The severity of FGIMDs ranges from mildly 21 uncomfortable to debilitating and in some cases can 22 be life-threatening. 23 (5) Effective treatments for the multiple symp- 24 toms of FGIMDs are lacking, and while sufferers 25 VerDate Sep 11 2014 23:19 Jun 26, 2019 Jkt 034408 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3396.IH H3396 pbinns on DSK79D2C42PROD with BILLS 3 •HR 3396 IH frequently use a variety of medications and therapies 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) Frequently there is a need for a multidisci- 9 plinary care approach to patients with FGIMDs, in- 10 cluding access to nutritional and mental health sup- 11 port to improve pain management and facilitate pa- 12 tient and parent understanding of the brain-gut axis 13 and overall patient functioning. 14 (8) Patients with FGIMDs frequently suffer for 15 years before receiving an accurate diagnosis, expos- 16 ing them to unnecessary and costly tests and proce- 17 dures including surgeries, as well as needless suf- 18 fering and expense. 19 (9) The economic impact of FGIMDs is high. 20 The annual cost in the United States for IBS alone 21 is estimated to be between $1.7 billion and $10 bil- 22 lion in direct medical costs (excluding prescription 23 and over-the-counter medications) and $20 billion in 24 indirect medical costs. 25 VerDate Sep 11 2014 23:19 Jun 26, 2019 Jkt 034408 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3396.IH H3396 pbinns on DSK79D2C42PROD with BILLS 4 •HR 3396 IH (10) FGIMDs frequently take a toll on the 1 workplace, as reflected in work absenteeism, lost 2 productivity, and lost opportunities for the individual 3 and society. 4 (11) Gastrointestinal symptoms consistent with 5 functional gastrointestinal disorders, such as IBS 6 and functional dyspepsia, are recognized as a serious 7 and disabling issue for military veterans, particularly 8 those who have been deployed in war zones and ex- 9 perience posttraumatic stress disorder. 10 (12) FGIMDs affect individuals of all ages in- 11 cluding children, and pediatric FGIMDs can be par- 12 ticularly serious, leading to a lifetime of painful 13 symptoms and medical expenses associated with 14 management of chronic illness or death, as well as 15 missed school days and homebound instruction. 16 (13) There is inadequate public education and 17 misunderstanding of FGIMDs leading to stigma 18 placed upon individuals so afflicted. 19 (14) The National Institutes of Health’s Na- 20 tional Commission on Digestive Diseases identified 21 comprehensive research goals related to FGIMDs in 22 its April 2009 report to Congress and the American 23 public entitled ‘‘Opportunities and Challenges in Di- 24 VerDate Sep 11 2014 23:19 Jun 26, 2019 Jkt 034408 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3396.IH H3396 pbinns on DSK79D2C42PROD with BILLS 5 •HR 3396 IH gestive Diseases Research: Recommendations of the 1 National Commission on Digestive Diseases’’. 2 SEC. 3. FUNCTIONAL GASTROINTESTINAL AND MOTILITY 3 DISORDERS RESEARCH ENHANCEMENT. 4 Part B of the title IV of the Public Health Service 5 Act (42 U.S.C. 284 et seq.) is amended by adding at the 6 end the following: 7 ‘‘SEC. 409K. FUNCTIONAL GASTROINTESTINAL AND MOTIL- 8 ITY DISORDERS. 9 ‘‘The Director of NIH may expand, intensify, and co- 10 ordinate the activities of the National Institutes of Health 11 with respect to functional gastrointestinal and motility dis- 12 orders (in this section referred to as ‘FGIMDs’) by— 13 ‘‘(1) expanding basic and clinical research into 14 FGIMDs by implementing the research rec- 15 ommendations of the National Commission on Di- 16 gestive Diseases relating to FGIMDs; 17 ‘‘(2) providing support for the establishment of 18 up to 5 centers of excellence on FGIMDs at leading 19 academic medical centers throughout the country to 20 carry out innovative basic, translational, and clinical 21 research focused on FGIMDs in both pediatric and 22 adult patients; 23 ‘‘(3) supporting innovative approaches to edu- 24 cating health care providers and patients regarding 25 VerDate Sep 11 2014 23:19 Jun 26, 2019 Jkt 034408 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3396.IH H3396 pbinns on DSK79D2C42PROD with BILLS 6 •HR 3396 IH strategies that improve patient-provider relationships 1 and care and foster research to determine the effects 2 of these approaches in improving patient satisfac- 3 tion, improved clinical outcomes, efficient utilization 4 of health care services, and reduced health care 5 costs; 6 ‘‘(4) exploring collaborative research opportuni- 7 ties among the National Institute of Diabetes and 8 Digestive and Kidney Diseases, the Office of Re- 9 search on Women’s Health, the Office of Rare Dis- 10 eases, the National Institute of Mental Health, and 11 other institutes and centers of the National Insti- 12 tutes of Health; 13 ‘‘(5) directing the National Institute of Diabe- 14 tes and Digestive and Kidney Diseases to provide 15 the necessary funding for continued expansion and 16 advancement of the FGIMDs research portfolio 17 through intramural and extramural research; 18 ‘‘(6) directing the National Institute of Diabe- 19 tes and Digestive and Kidney Diseases and the Eu- 20 nice Kennedy Shriver National Institute of Child 21 Health and Human Development to expand research 22 into FGIMDs that impact children, such as 23 Hirschsprung’s disease and cyclic vomiting syn- 24 VerDate Sep 11 2014 23:19 Jun 26, 2019 Jkt 034408 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3396.IH H3396 pbinns on DSK79D2C42PROD with BILLS 7 •HR 3396 IH drome, and maternal health, such as fecal inconti- 1 nence; and 2 ‘‘(7) exploring opportunities to partner with the 3 Department of Defense and the Department of Vet- 4 erans Affairs to increase research and improve pa- 5 tient care regarding FGIMDs that commonly impact 6 veterans and active duty military personnel, such as 7 IBS and dyspepsia.’’. 8 SEC. 4. PROMOTING PUBLIC AWARENESS OF FUNCTIONAL 9 GASTROINTESTINAL AND MOTILITY DIS- 10 ORDERS. 11 Part B of title III of the Public Health Service Act 12 (42 U.S.C. 243 et seq.) is amended by adding at the end 13 the following: 14 ‘‘SEC. 320B. PUBLIC AWARENESS OF FUNCTIONAL GASTRO- 15 INTESTINAL AND MOTILITY DISORDERS. 16 ‘‘The Secretary may engage in public awareness and 17 education activities to increase understanding and recogni- 18 tion of functional gastrointestinal and motility disorders 19 (in this section referred to as ‘FGIMDs’). Such activities 20 may include the distribution of print, film, and web-based 21 materials targeting health care providers and the public 22 and prepared and disseminated in conjunction with pa- 23 tient organizations that treat FGIMDs. The information 24 expressed through such activities should emphasize— 25 VerDate Sep 11 2014 23:19 Jun 26, 2019 Jkt 034408 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3396.IH H3396 pbinns on DSK79D2C42PROD with BILLS 8 •HR 3396 IH ‘‘(1) basic information on FGIMDs, their symp- 1 toms, prevalence, and frequently co-occurring condi- 2 tions; and 3 ‘‘(2) the importance of early diagnosis, and 4 prompt and accurate treatment of FGIMDs, includ- 5 ing access to nutritional and mental health sup- 6 port.’’. 7 SEC. 5. SENSE OF CONGRESS OF THE DEVELOPMENT AND 8 OVERSIGHT OF INNOVATIVE TREATMENT OP- 9 TIONS FOR FUNCTIONAL GASTROINTESTINAL 10 AND MOTILITY DISORDERS. 11 It is the sense of Congress that, considering the cur- 12 rent lack of effective treatment options for the global 13 symptoms of functional gastrointestinal and motility dis- 14 orders (in this section referred to as ‘‘FGIMDs’’) and the 15 inherent challenges of developing and bringing such treat- 16 ments to market, the Commissioner of Food and Drugs 17 should continue and accelerate important efforts to im- 18 prove the development and oversight of treatment options 19 for FGIMDs by— 20 (1) enhancing the commitment to emerging ef- 21 forts like the Patient Reported Outcomes Consor- 22 tium to expedite medical device and drug develop- 23 ment, the study of appropriate balances between risk 24 and patient benefit, and identification of proper 25 VerDate Sep 11 2014 23:19 Jun 26, 2019 Jkt 034408 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3396.IH H3396 pbinns on DSK79D2C42PROD with BILLS 9 •HR 3396 IH endpoints for conditions without clear, biological in- 1 dicators; 2 (2) enhancing the commitment to broad efforts 3 like the Critical Path Initiative focused on ensuring 4 that scientific breakthroughs are quickly translated 5 into safe and beneficial treatment options for both 6 pediatric and adult patients; and 7 (3) continuing collaboration with patient and 8 provider organizations that treat FGIMDs so that 9 the patient perspective is considered when deter- 10 mining the need for innovative treatments. 11 Æ VerDate Sep 11 2014 23:19 Jun 26, 2019 Jkt 034408 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\H3396.IH H3396 pbinns on DSK79D2C42PROD with BILLS