Oley Helps Coordinate FDA Listening Session on Short Bowel Syndrome

FDA Patient Listening Session Focuses on SBS

On July 19, 2022, FDA held a PLS on short bowel syndrome (SBS). This came about because David Franco, the father of a child with SBS, wanted to utilize this platform to share SBS patient and caregiver lived experiences and hopes for the future. The Oley Foundation was invited to fill out a request for an FDA listening session and help develop the agenda, and then, when the request was accepted, to help identify other SBS patients and caregivers, coordinate the session, and later provide a written summary.

The U.S. Food and Drug Administration (FDA) hosts patient listening sessions (PLS) as an opportunity for the patient and advocacy community to “share their experiences and perspectives…directly with FDA staff.” They “help the FDA better understand what is most important to different communities and individuals who have specific health, medical, and treatment needs.” See fda.gov/patients/learn-about-fda-patientengagement/fda-patient-listening-sessions for more details.

What was the Short Bowel Syndrome PLS process?

The FDA laid out the process, worked with us to finalize the agenda, and even facilitated several meetings leading up to this PLS. They were keen on hearing experiences, perspectives, and needs related to SBS, and not about drug, biologic, or device products. Approximately sixty FDA staff from twenty-four different offices across five FDA centers attended this ninety-minute session, which included a twenty-plus-minute lively interactive question-and-answer period.

A gastroenterologist who specializes in pediatrics and transitioning to adult care was selected to share the medical overview of SBS, its causes and general complications. Seven patients and caregivers represented a timespan of as recent as two years to over thirty-five years of living with SBS. The final agreed-upon agenda included the topics of home parenteral nutrition; sleep disturbance; diarrhea; lifestyle accommodations; drug, device, and surgical options; and hope for future innovation in the field. A detailed summary of the topics can be found at oley. org/FDA_Listening.

What was happening behind the scenes?

The FDA attendees were engaged, many staying beyond the designated time to continue to get questions answered. Oley staff members Joan Bishop, Beth Gore, and Lisa Metzger participated in various behind-the-scenes roles, including coordination of agenda and participants, and notetaking. The FDA was helpful leading up to and during the process. The patients and caregivers were supportive of one another throughout the process, often prompting each other with encouragement and agreeing on common and shared experiences. To allow patients and caregivers to share openly, these sessions are not recorded; the only takeaway is the written summary.

What’s next?

In speaking with various nutrition support stakeholder community members, Oley is beginning to work on advocacy plans for 2023 and beyond. Included in the discussion of options are:

• Qualitative Patient Experience Research topics

• Submission for an FDA PLS on the topic of home parenteral nutrition

• National summit on the components of care for intestinal failure/nutrition support

• National/International Home Nutrition Support Patient Bill of Rights

Support Patient Bill of Rights

These big-picture efforts are meant to build on the momentum gained with this PLS and complement existing advocacy efforts, such as increasing general awareness of home tube feeding and parenteral nutrition; gaining passage of legislation that will help increase patient access to care, and coverage of tube feeding formula; and addressing drug shortages, particularly as related to home nutrition support.

How can you get involved?

Consumers and Caregivers: Oley wants to identify people who are willing to share their journey. One way we identify both the nature and needs of our community and the individuals within it who may help represent these, is through our database. The more complete this information is, the better we know whom to call on for future advocacy efforts, potential volunteer opportunities, speaking engagements, clinical or market research, etc. Please sign in at oley.org and update your profile.

Clinicians and Professionals: We are seeking people interested in supporting Oley through speaking engagements, task forces, committees, creating or editing quality education content, and other volunteer opportunities.

Industry and Corporations: Oley is seeking collaborative resources, trends in the community, expertise, innovation, dialogue, and funding. If you are a partner organization, you are already part of the Oley Industry Advisory Council. If you are not but would like to know the benefits of Oley Partnership, contact Beth Gore at beth.gore@oley.org. Please update your profile, too!

Anyone: Drop us a line at info@oley.org.

Disclaimer

Discussions in FDA Patient Listening Sessions are informal. All opinions, recommendations, and proposals are unofficial and nonbinding on FDA and all other participants. This report reflects the Oley Foundation’s account of the perspectives of patients and caregivers who participated in the Patient Listening Session with the FDA. To the extent possible, the terms used in this summary to describe specific manifestations of short bowel syndrome, health effects and impacts, and treatment experiences, reflect those of the participants. This report is not meant to be representative of the views and experiences of the entire short bowel syndrome patient population or any specific group of individuals or entities. There may be experiences that are not mentioned in this report.