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Oral Comments to FDA May 11, 2015

On May 11, 2015, Tegan Gaetano took part in and presented the following comments on behalf of IFFGD members at the FDA Patient-Focused Drug Development public meeting on Functional GI Disorders:

Good afternoon. My name is Tegan Gaetano. I work for a patient advocacy organization, the International Foundation for Functional Gastrointestinal Disorders, or IFFGD. I appreciate the opportunity to provide our comments here today.

For almost 25 years, IFFGD has been working 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.

The functional GI disorders cause a tremendous individual and societal burden, both in terms of economic and personal costs. Disorders such as IBS, chronic constipation, refractory GERD, or gastroparesis can be debilitating, taking away a person’s ability to participate in daily life – in family, social, educational, or employment activities. In the case of gastroparesis, the condition may sometimes be life-threatening.

Although dozens of conditions have been characterized as functional GI disorders, affecting the different segments of the GI tract, these conditions share many common features. Among them they are chronic, effective treatments are few, and most are characterized by combinations of multiple symptoms that can greatly diminish quality of life.

Although research into functional GI disorders has long lagged behind the study of structural disorders, over the past two decades research has been increasingly focusing on these disorders. Among the many things we have learned is that there are too few effective treatments for these disorders and that among patients there is a high level of dissatisfaction with treatments that are available. Treatments that work for simple, acute, constipation, diarrhea, heartburn, stomach pain, or nausea, to name a few, are not adequate for the chronic symptoms that accompany the functional GI disorders.

Understanding and appreciating the burden of illness that these conditions impose are important steps forward in recognizing the need for more and improved treatments. Engaging patients to learn about their illness-related needs and concerns is essential to advancing progress in understanding and addressing these disorders. This meeting helps give voice to those needs.

Thank you.

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