IFFGD President and Co-Founder, Nancy J. Norton submitted the following written statement on July 16, 2014 to the U.S. Food and Drug Administration Center for Drug Evaluation and Research in response to docket number: FDA-2010-D-0503:

On behalf of the International Foundation for Functional Gastrointestinal Disorders (IFFGD), I would like to thank the U.S. Food and Drug Administration (FDA) for its work to evaluate the safety of treatments for conditions that affect the public. IFFGD is a 501(c)(3) nonprofit education and research organization dedicated to improving the understanding of functional gastrointestinal and motility disorders (FGIMDs). Our mission is to inform, assist, and support people affected by these chronic and often debilitating digestive conditions for which too few treatment options exist.

I am writing to you in regard to Docket No. FDA-2010-D-0503, section VI, subsection D ("Foods") of the FDA’s September 2013 "Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND." Although the open comment period is closed, we hope you will consider our comments on this Guidance.

We applaud the goals of the Guidance to "address a range of issues that, in FDA’s experience, have been the source of confusion or misperceptions about the application of the IND regulations." However, we are concerned that the Foods section of the Guidance is vague and unclear, and will inhibit clinical research that can benefit patients.

Food and nutrition related therapies represent a growing area of investigative interest. In addition to use in managing specific dietary needs or distinctive nutritional requirements, they have shown potential to reduce symptoms of FGIMDs. The new guidance has introduced confusion and uncertainty regarding the conditions under which a food is to be considered as a drug requiring an IND for research. We are concerned this places an unnecessary, and possibly unintended, burden on researchers that can inhibit development of new treatments.

We therefore offer the following suggestions regarding the Guidance:

Postpone the implementation of the Guidance so that concerns and recommendations regarding changes to IND procedure can be voiced through public comment.

Open a dialogue with interested parties, including patients, investigators, and industry representatives.

Refine the language of the Guidance to reduce confusion and unnecessary burden about the exact research conditions for which an IND will be required.

Thank you for your consideration of our comments.

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