Last week, the International Foundation for Functional Gastrointestinal Disorders and its grassroots arm, the Digestive Health Alliance, announced that the U.S. Food and Drug Administration has chosen three functional gastrointestinal and motility disorders to be included in its “patient focused initiative.” (See IFFGD/DHA April 2013 FDA news here.) The FDA is responsible for the review, approval and regulation of medications in the U.S. The entire initiative is scheduled to take place over five years and include 20 serious medical conditions. The three digestive disorders, irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD) with regurgitation on proton pump inhibitors, and gastroparesis, are among the 16 diverse medical conditions in total that were selected for the first three years.
The program will involve public meetings and other means for the FDA to hear experiences from people affected by the selected conditions. According to recent information from DHA, the FDA has put up a new Patient Network website to invite comment from individuals with the disorders or concerned supporters, and there will also be opportunities for interested parties to apply to be Patient Representatives for FDA advisory committees. It is hoped that these meetings will positively influence FDA decision-making in regard to medical conditions that represented in this program. To quote information previously provided by IFFGD/DHA, the FDA’s criteria for inclusion in this initiative are:
- Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
- Disease areas that reflect a range of severity;
- Disease areas for which aspects of the disease are not formally captured in clinical trials;
- Disease areas that have a severe impact on identifiable subpopulations;
- Disease areas that represent a broad range in terms of size of the affected population; or disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives
As many people with IBS and our supporters are aware, many of these criteria fit IBS very well. This exciting news appears to be partly as a result of advocacy by IFFGD/DHA, with the the support of IBS Impact and other entities and individuals in the functional GI and motility community, during an FDA public comment period in the fall of 2012. (See the October 20, 2012 post.) At that time, IBS was the only functional GI and motility disorder identified among 39 diverse disorders as a possible candidate for the initiative. That it was chosen in the first round, along with two other functional GI and motility disorders not previously considered, appears to be a positive sign for increased awareness of digestive health needs in this federal government regulatory agency.
IBS Impact thanks IFFGD/DHA and all those who took the time to share their comments, lived experiences and the impact of IBS, GERD or gastroparesis with the FDA at the time of the original action alert. It is hoped that the representation of these three disorders in the patient focused initiative will create other opportunities for our community and pave the way for many long-term, positive and systemic changes for us all.