UPDATE: 05/01/2013 : In April 2013, the FDA selected IBS as one of 3 functional gastrointestinal disorders and one of 16 varied disorders in total for the first 3 years of this program. See more information in the May 1, 2013 post.
The International Foundation for Functional Gastrointestinal Disorders and its grassroots arm, the Digestive Health Alliance, has issued a new advocacy alert yesterday. According to information provided by IFFGD/DHA, the U.S Food and Drug Administration, which is responsible for the review, approval and regulation of medications sold in the U.S, has identified irritable bowel syndrome (IBS) as one of 39 health conditions to be considered for a new “patient-focused initiative.” The FDA will ultimately choose 20 of these 39 for this program, which will involve public meetings over the next 5 years with people affected by the conditions to discuss their experiences. It is hoped that these meetings will positively influence FDA decision-making in regard to these disorders. To quote IFFGD/DHA’s alert, 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. The FDA is having a public comment period that ends on November 1, 2012. IFFGD/DHA is asking the IBS community to send our comments to the FDA in order to advocate for IBS to be selected for the final list of disorders in this initiative. While at this time, irritable bowel syndrome is the only functional gastrointestinal and motility disorder specifically identified as a candidate for the initiative, IFFGD/DHA indicates that the FDA welcomes and IFFGD/DHA encourages those affected by other FGIMDs to comment as well on the impact of their specific conditions for the FDA’s general awareness of such disorders. The FDA comment form also accommodates comments from international sources, so if any readers of this blog outside the U.S. would like to share their views and experiences, IBS Impact encourages you to do so. Anyone who chooses to submit a comment, please clearly state the disorder about which you are commenting, and use the FDA criteria quoted above to guide the details of your experiences that you discuss.
The Digestive Health Alliance page explaining this action alert includes a link to the correct FDA page here. DHA FDA Alert, October 2012
If you prefer to go directly to the FDA comment page for this specific issue, please click here. FDA Patient-Focused Drug Development Comment Form. Please note that although the heading states “Prescription Drug User Fee Act” and does not mention IBS specifically, as many conditions are under consideration, this is the correct link.
IFFGD/DHA and IBS Impact urge people with IBS and those who support us to take this opportunity to explain our lived experiences with IBS and the impact on our lives. Our advocacy to ensure that IBS is ultimately included in this initiative will create other opportunities for public comment that have the potential to influence the FDA regarding IBS in a manner that can pave the way for long-term, systemic changes to benefit our community.