2239 112th CONGRESS
H. R. 2239
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
Mr. SENSENBRENNER (for himself and Mr. MORAN) introduced
the following bill; which was referred to the Committee on Energy and Commerce
To expand the research activities
of the National Institutes of Health with respect to functional gastrointestinal
and motility disorders, and for other purposes.
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 2011'.
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 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 conditions such as dysphagia, gastroesophageal reflux disease,
dyspepsia, cyclic vomiting syndrome, gastroparesis, irritable bowel syndrome (IBS),
Hirschsprung's disease, chronic intestinal pseudo-obstruction, bowel incontinence,
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 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) 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.
(7) 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.
(8) FGIMDs frequently
take a toll on the workplace, as reflected in work absenteeism, lost productivity,
and lost opportunities for the individual and society.
(9) Gastrointestinal symptoms consistent with functional gastrointestinal disorders
such as IBS and functional dyspepsia have been recognized as a serious and disabling
issue for military veterans, particularly those who have been deployed.
(10) 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.
(11) 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
SEC. 3. FUNCTIONAL GASTROINTESTINAL AND MOTILITY
DISORDERS RESEARCH ENHANCEMENT.
Part B of title IV of the Public
Health Service Act (42 U.S.C. 284 et seq.) is amended by adding at the end the
`SEC. 409K. FUNCTIONAL GASTROINTESTINAL AND MOTILITY
`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')
`(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 five 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;
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 Disease Research, and other Institutes and Centers of the National
Institutes of Health;
`(4) 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;
`(5) 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
`(6) 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.
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.
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 activites should emphasize--
`(1) basic information on FGIMDs, their symptoms, prevalence, and frequently co-occurring
`(2) the importance of early diagnosis,
and prompt and accurate treatment of FGIMDs.'.
SEC. 5. SENSE
OF CONGRESS ON 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, study appropriate balances between risk and
patient benefit, and identify proper endpoints for conditions without clear, biological
(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; and
(3) continuing collaboration with patient organizations that treat FGIMDs so that
the patient perspective is considered when determining the need for innovative