[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3396 Introduced in House (IH)]

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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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Functional Gastrointestinal and 
Motility Disorders Research Enhancement Act of 2019''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Functional gastrointestinal and motility disorders 
        (FGIMDs) are chronic conditions associated with increased 
        sensitivity of the GI tract, abnormal motor functioning, and 
        brain-gut dysfunction.
            (2) FGIMDs are characterized by chronic or recurring 
        symptoms in the GI tract including pain or discomfort, nausea, 
        vomiting, diarrhea, constipation, incontinence, problems in the 
        passage of food or feces, or a combination of these symptoms.
            (3) FGIMDs include both common and rare conditions, such as 
        functional dysphagia, gastroesophageal reflux disease, 
        dyspepsia, cyclic vomiting syndrome, gallbladder and bile duct 
        dysfunction, gastroparesis, irritable bowel syndrome (IBS), 
        Hirschsprung's disease, chronic intestinal pseudo-obstruction, 
        bowel incontinence, opioid induced GI hyperalgesia, abdomino-
        phrenic dyssynergia (APD), and many others, which affect the 
        esophagus, stomach, gallbladder, small and large intestine, and 
        anorectal areas of the body.
            (4) The severity of FGIMDs ranges from mildly uncomfortable 
        to debilitating and in some cases can be life-threatening.
            (5) Effective treatments for the multiple symptoms of 
        FGIMDs are lacking, and while sufferers frequently use a 
        variety of medications and therapies for symptoms, few patients 
        report satisfaction with available treatments.
            (6) Physicians are not sufficiently educated on the proper 
        diagnosis and up-to-date treatments for FGIMDs. This leads to 
        excess health care costs due to unneeded diagnostic procedures 
        and errors in treatments.
            (7) Frequently there is a need for a multidisciplinary care 
        approach to patients with FGIMDs, including access to 
        nutritional and mental health support to improve pain 
        management and facilitate patient and parent understanding of 
        the brain-gut axis and overall patient functioning.
            (8) Patients with FGIMDs frequently suffer for years before 
        receiving an accurate diagnosis, exposing them to unnecessary 
        and costly tests and procedures including surgeries, as well as 
        needless suffering and expense.
            (9) The economic impact of FGIMDs is high. The annual cost 
        in the United States for IBS alone is estimated to be between 
        $1.7 billion and $10 billion in direct medical costs (excluding 
        prescription and over-the-counter medications) and $20 billion 
        in indirect medical costs.
            (10) FGIMDs frequently take a toll on the workplace, as 
        reflected in work absenteeism, lost productivity, and lost 
        opportunities for the individual and society.
            (11) Gastrointestinal symptoms consistent with functional 
        gastrointestinal disorders, such as IBS and functional 
        dyspepsia, are recognized as a serious and disabling issue for 
        military veterans, particularly those who have been deployed in 
        war zones and experience posttraumatic stress disorder.
            (12) FGIMDs affect individuals of all ages including 
        children, and pediatric FGIMDs can be particularly serious, 
        leading to a lifetime of painful symptoms and medical expenses 
        associated with management of chronic illness or death, as well 
        as missed school days and homebound instruction.
            (13) There is inadequate public education and 
        misunderstanding of FGIMDs leading to stigma placed upon 
        individuals so afflicted.
            (14) The National Institutes of Health's National 
        Commission on Digestive Diseases identified comprehensive 
        research goals related to FGIMDs 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''.

SEC. 3. FUNCTIONAL GASTROINTESTINAL AND MOTILITY DISORDERS RESEARCH 
              ENHANCEMENT.

    Part B of the title IV of the Public Health Service Act (42 U.S.C. 
284 et seq.) is amended by adding at the end the following:

``SEC. 409K. FUNCTIONAL GASTROINTESTINAL AND MOTILITY DISORDERS.

    ``The Director of NIH may expand, intensify, and coordinate the 
activities of the National Institutes of Health with respect to 
functional gastrointestinal and motility disorders (in this section 
referred to as `FGIMDs') by--
            ``(1) expanding basic and clinical research into FGIMDs by 
        implementing the research recommendations of the National 
        Commission on Digestive Diseases relating to FGIMDs;
            ``(2) providing support for the establishment of up to 5 
        centers of excellence on FGIMDs at leading academic medical 
        centers throughout the country to carry out innovative basic, 
        translational, and clinical research focused on FGIMDs in both 
        pediatric and adult patients;
            ``(3) supporting innovative approaches to educating health 
        care providers and patients regarding strategies that improve 
        patient-provider relationships and care and foster research to 
        determine the effects of these approaches in improving patient 
        satisfaction, improved clinical outcomes, efficient utilization 
        of health care services, and reduced health care costs;
            ``(4) exploring collaborative research opportunities among 
        the National Institute of Diabetes and Digestive and Kidney 
        Diseases, the Office of Research on Women's Health, the Office 
        of Rare Diseases, the National Institute of Mental Health, and 
        other institutes and centers of the National Institutes of 
        Health;
            ``(5) directing the National Institute of Diabetes and 
        Digestive and Kidney Diseases to provide the necessary funding 
        for continued expansion and advancement of the FGIMDs research 
        portfolio through intramural and extramural research;
            ``(6) directing the National Institute of Diabetes and 
        Digestive and Kidney Diseases and the Eunice Kennedy Shriver 
        National Institute of Child Health and Human Development to 
        expand research into FGIMDs that impact children, such as 
        Hirschsprung's disease and cyclic vomiting syndrome, and 
        maternal health, such as fecal incontinence; and
            ``(7) exploring opportunities to partner with the 
        Department of Defense and the Department of Veterans Affairs to 
        increase research and improve patient care regarding FGIMDs 
        that commonly impact veterans and active duty military 
        personnel, such as IBS and dyspepsia.''.

SEC. 4. PROMOTING PUBLIC AWARENESS OF FUNCTIONAL GASTROINTESTINAL AND 
              MOTILITY DISORDERS.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by adding at the end the following:

``SEC. 320B. PUBLIC AWARENESS OF FUNCTIONAL GASTROINTESTINAL AND 
              MOTILITY DISORDERS.

    ``The Secretary may engage in public awareness and education 
activities to increase understanding and recognition of functional 
gastrointestinal and motility disorders (in this section referred to as 
`FGIMDs'). Such activities may include the distribution of print, film, 
and web-based materials targeting health care providers and the public 
and prepared and disseminated in conjunction with patient organizations 
that treat FGIMDs. The information expressed through such activities 
should emphasize--
            ``(1) basic information on FGIMDs, their symptoms, 
        prevalence, and frequently co-occurring conditions; and
            ``(2) the importance of early diagnosis, and prompt and 
        accurate treatment of FGIMDs, including access to nutritional 
        and mental health support.''.

SEC. 5. SENSE OF CONGRESS OF THE DEVELOPMENT AND OVERSIGHT OF 
              INNOVATIVE TREATMENT OPTIONS FOR FUNCTIONAL 
              GASTROINTESTINAL AND MOTILITY DISORDERS.

    It is the sense of Congress that, considering the current lack of 
effective treatment options for the global symptoms of functional 
gastrointestinal and motility disorders (in this section referred to as 
``FGIMDs'') and the inherent challenges of developing and bringing such 
treatments to market, the Commissioner of Food and Drugs should 
continue and accelerate important efforts to improve the development 
and oversight of treatment options for FGIMDs by--
            (1) enhancing the commitment to emerging efforts like the 
        Patient Reported Outcomes Consortium to expedite medical device 
        and drug development, the study of appropriate balances between 
        risk and patient benefit, and identification of proper 
        endpoints for conditions without clear, biological indicators;
            (2) enhancing the commitment to broad efforts like the 
        Critical Path Initiative focused on ensuring that scientific 
        breakthroughs are quickly translated into safe and beneficial 
        treatment options for both pediatric and adult patients; and
            (3) continuing collaboration with patient and provider 
        organizations that treat FGIMDs so that the patient perspective 
        is considered when determining the need for innovative 
        treatments.
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