National Institutes of Health (NIH)
Overall Investment in NIH: We support increasing funding for NIH to a level of at least $32 billion in FY16. The bulk of federally supported FGIMDs research is conducted through the National Institute of Diabetes, and Digestive, and Kidney Diseases (NIDDK). Increased support for NIH will enable NIDDK and other Institutes and Centers to continue to expand the FGIMD research portfolio and initiate critical new research activities focused on improving our understanding of these conditions and leading to the development of innovative treatment options.
Support The Functional GI and Motility Disorders Research Enhancement Act: This critical piece of legislation seeks to advance our scientific understanding of FGIMDs and improve treatment options for patients by encouraging and bolstering research. This bill calls on NIH to adopt and implement the FGIMD-related research recommendations outlined by the National Commission on Digestive Diseases. In addition, this bill calls on NIH to partner with the Department of Defense (DOD) and the Department of Veterans Affairs (VA) to increase research activities. We urge Members of Congress to champion FGIMD research by becoming a House of Representatives cosponsor or Senate sponsor of The Functional GI and Motility Disorders Research Enhancement Act.
The onset of a functional GI disorder can be triggered by severe stress and infections of the digestive tract. Deployed military personnel face an elevated chance of experiencing these risk factors and developing a functional GI disorder due to their service. As a result, the VA recognizes a "presumption of service" connection for Gulf War veterans applying for disability who suffer with functional GI disorders. The DOD conducts important research into medical conditions that impact veterans and active duty military personnel through its Congressionally Directed Medical Research Program (CDMRP).
The House and Senate Defense Appropriations Subcommittees fund the DOD CDMRP’s Gulf War Illness Research Program (GWIRP), which provides an excellent source of funding for functional GI disorders research. Legislators must work to see that funding for the GWIRP is included in any agreement on FY15 Defense Appropriations.
Support funding for the National Pediatric Research Network Act: Many children suffer with painful, disabling, and in some cases life-threatening FGIMDs. Increased pediatric research is badly needed so that a life-time of discomfort and costly medical treatment can be averted by individuals affected by FGIMDs. This law calls on NIH to establish pediatric research consortia. Please work to ensure that this law is implemented with funding for a pediatric FGIMD network.
Medical foods are physician-directed foods intended for the dietary management of a disease or condition that has distinctive nutritional needs that cannot be met by normal diet alone and are used under medical supervision. Many individuals with FGIMDs benefit from medical foods. However, advances in and access to medical foods are now in jeopardy as a result of FDA’s 2013 Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND, which recommends that medical foods be treated as drugs. The guidance represents a significant expansion of regulation, was published without prior notice or public discussion, is vague, and will inhibit clinical research. Please ask the FDA for clarification regarding the reasons and purpose for new guidance governing medical foods and request that an open and public process be implemented to consider the needs and impact of any new guidance from FDA in this regard.