[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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