1.This Act may be cited as the
Functional Gastrointestinal and
Motility Disorders Research Enhancement Act of
2011
.
2.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 Diseases
.
3.Functional
gastrointestinal and motility disorders research enhancementPart 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
following:
409K.Functional
gastrointestinal and motility disordersThe 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 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;
(3)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 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.
.
4.Promoting public
awareness of functional gastrointestinal and motility disordersPart 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:
320B.Public
awareness of functional gastrointestinal and motility disordersThe 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 activites 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.
.
5.Sense of Congress
on the development and oversight of innovative treatment options for functional
gastrointestinal and motility disordersIt 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 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; and
(3)continuing collaboration with patient
organizations that treat FGIMDs so that the patient perspective is considered
when determining the need for innovative treatments.