The following written comments were submitted to the Dockets Management Staff (HFA-305) Food and Drug Administration by IFFGD President, Ceciel T. Rooker, in response to Docket No. FDA-2019-D-4247 on December 30, 2019.

 

 

Thank you for your leadership at the Center for Drug Evaluation and Research in the Food and Drug Administration (FDA). The International Foundation for Gastrointestinal Disorders (IFFGD) is grateful for the opportunity to comment on the FDA’s Draft Guidance for industry Food and Drug Administration staff, and other stakeholders entitled “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients” (Docket No. FDA-2019-D-4247).

IFFGD is a registered nonprofit education and research organization dedicated to informing, assisting, and supporting people affected by gastrointestinal (GI) disorders. IFFGD works with patients, families, physicians, nurses, practitioners, investigators, regulators, employers, and others to broaden understanding about GI disorders, support and encourage research, and improve digestive health in adults and children.

Functional GI and motility disorders are the most common GI disorders in the general population. These disorders are classified by symptoms related to any combination of the following: motility disturbance, visceral hypersensitivity, altered mucosal and immune function, altered gut microbiota, and altered central nervous system (CNS) processing. Some examples of functional GI disorders are: dyspepsia, gastroparesis, irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), bowel incontinence, and cyclic vomiting syndrome.

We would like to commend the Federal Drug Administration and Department of Health and Human Services on their dedication to ensure that drug development includes what is important for patients and for encouraging that the patient voice is heard. This draft guidance is a thorough guideline, providing industry and other stakeholders with varying, manageable options to include patient needs and opinions.

Comments on VI. Specific Populations (Rare Diseases) and Culturally Diverse Populations

Line 430.

We agree that remote assessment can be useful in geographically diverse patient populations, as this is a common burden locating patients affected by rare diseases. Although, remote assessment should also be considered for many rare diseases, including those affecting the GI tract. Many chronic GI and motility disorders accompanied by varying degrees of symptoms, causing some patients to be very limited or unable to travel. This should also include considerations for those with limited mobility and disabilities.

This aspect of the disease burden should be considered for all disease states. Line 234 “Do not assume you know what the participant is thinking or feeling,” is an important statement that should be considered at all points throughout the planning process. There is no way to know the degree of a disease burden or what an important outcome is, unless this is discussed with patients themselves.

IFFGD works on behalf of the gastrointestinal and motility disorder community and fosters strong relationships with patients and caregivers. Many of which share an active interest to share their experiences, insight, and time to benefit other patients and families. IFFGD appreciates the FDA’s work to revise the agency’s current thinking on ways to include what is important to patients through engagement in patient-focused drug development. Thank you for this opportunity to comment on this guidance for methods to identify what is important to patients.

We hope you will consider the Foundation a resource as you work to finalize this rulemaking.

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