On June 29, 2015, William Norton presented the following Public Docket comments on behalf of IFFGD members in regard to the FDA Patient-Focused Drug Development public meeting on Functional GI Disorders:

On behalf of the International Foundation for Functional Gastrointestinal Disorders (IFFGD) I appreciate this opportunity to offer additional comments, including the attached reports, regarding the Functional GI Disorders Patient-Focused Drug Development Public Meeting held on May 11, 2015.

IFFGD works on behalf of patients affected by functional GI disorders. We have conducted research to learn about this population, sharing our findings with the public, the healthcare community, and with regulators such as FDA in order to advance understanding of the burden of illness and unmet needs of those affected.

In particular, we wish to share the following research reports with you:

In 2002 we published findings from our national telephone survey of 350 IBS patients, IBS in the Real World Survey, providing insight into the experience of living with IBS including the symptoms, treatments, side effects, and the overall impact of the condition.

In 2009 we published findings from our online survey, IBS Patients: Their Illness Experience and Unmet Needs, in which 1,966 patients provided a vivid profile of their illness experience, how it impacts their lives, and the risks many would accept to find relief from the debilitating effects of IBS. A more detailed report of these findings was published in the peer-reviewed Journal of Clinical Gastroenterology.

In 2015 we conducted an online survey of over 1,000 gastroparesis patients. The preliminary results present a similar picture of chronic, debilitating symptoms, that negatively impact daily living, and for which there are few effective treatments. We look forward to sharing the results of this survey with you when our report on the data is completed.

We believe that patients managing chronic functional GI disorders do best when they work in partnership with their doctors. Accordingly, patients should be allowed to make informed treatment decisions while their doctors exercise clinical judgments based on the unique circumstances of each individual. We ask that the FDA do what it can to help ensure patients have access to as many treatment options as possible, in conjunction with regulatory review that takes into account the tremendous burden which functional GI disorders can place on the individuals affected.

Thank you for your consideration of our comments.

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