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PLF Organizes First-Ever FDA Patient-led Listening Session: Clostridioides difficile Infection

New York, NY (July 7, 2022) - Peggy Lillis Foundation, a non-profit for Clostridioides difficile (C. diff) Education & Advocacy organized the first-ever patient-led listening session for C diff. held by the Food & Drug Administration (FDA). In attendance was 70 FDA staff from 26 offices/divisions across four FDA Centers. Speaking were seven C. diff survivors, three C. diff caregivers, and one clinician. A summary of the patient-led listening session has just been released as the initial session was closed to the public.

The objective of the C. diff patient listening session, held in March, was to provide the FDA staff with a comprehensive understanding of the challenges patients face in managing recurrent C. diff infections (rCDI), and to improve the safety and effectiveness of C. diff treatments. FDA hosts Patient Listening Sessions as a resource for the medical product Centers to engage with patients and their advocates. These informal, non-regulatory meetings allow participants to connect with FDA staff first-hand to share patient experiences, perspectives and needs relating to their health or disease. 

“The FDA has a crucial role to play in combating the C. diff epidemic,” said Christian John Lillis, executive director of the Peggy Lillis Foundation. “March’s Patient Listening Session is the first step in bringing the perspective of C. diff patients and caregivers into the FDA’s consideration of preventatives, diagnostics and treatments for this terrible infection. We look forward to growing our relationship with FDA to ensure C. diff patients get what is needed to make this infection rare, treatable and survivable.” 

The session included a discussion of the overview of rCDI, unmet prevention, diagnostic, and treatment needs of C. diff patients, and a discussion of patient and caregiver perspectives on impactful symptoms, treatment outcomes and concerns. This discussion was followed by a question-and-answer segment. Topics discussed in the Q&A with FDA staff included industry collaboration, key needs for improving patient experience, treatment efficacy and underlying conditions and patients’ perspectives on fecal microbiota transplants. 

A full summary of the FDA Patient Listening Session for C diff. can be found here

About Peggy Lillis Foundation 

Founded in response to the April 2010 death of a 56-year-old kindergarten teacher, Peggy Lillis Foundation for C. diff Education & Advocacy (PLF) is the leading national organization dedicated to combating C. difficile infections through educating the public, empowering advocates and shaping policy. PLF envisions a world where C. diff is rare, treatable and survivable. For more information visit