Registration for Food and Drug Administration May 2015 Public Meeting for IBS, GERD, Gastroparesis, Chronic Idiopathic Constipation Patients Now Open
In April 2013, the International Foundation for Functional Gastrointestinal Disorders and its grassroots arm, the Digestive Health Alliance, announced that the U.S. Food and Drug Administration had chosen three functional gastrointestinal and motility disorders to be included in its “patient focused initiative.” (See the May 1, 2013 blog post.) The FDA is responsible for the review, approval and regulation of medications in the U.S. The entire initiative was scheduled to take place over five years and include 20 chronic medical conditions that, based on several factors the FDA considered sufficiently serious to warrant increased attention and drug development. The three digestive disorders, irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD) with regurgitation on proton pump inhibitors, and gastroparesis, were among the 16 diverse medical conditions in total that were selected during the first round. Another functional GI disorder, chronic idiopathic constipation (CIC) has since been added. The program involves public meetings and other means for the FDA to hear experiences from people affected by the selected conditions.
IFFGD/DHA has now announced that the FDA will hold one of these meetings on Monday May 11, 2015 from 1:00 pm to 5:00 pm Eastern time at the FDA campus in Silver Spring, MD. People with IBS, GERD that does not respond to standard treatments, gastroparesis and/or chronic idiopathic constipation (CIC) may now register to attend in person, attend through online webinar, or to submit comments online through the FDA comment docket. Registration will close on May 1. Further information can be found at the link below.
Along with IFFGD/DHA, IBS Impact encourages people affected by the above conditions to consider participating in the public meeting or submitting comments, which is a unique opportunity to influence future FDA directions and policies regarding these disorders. It is hoped that the representation of four functional GI and motility 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.