FDA Patient Listening Session

FDA Patient Listening Session is an opportunity to discuss the symptoms, manifestations and the differences between patients, and the emotional toll of VHL.

On June 11th, 2020, the VHL Alliance participated in virtual FDA Patient Listening Session. Seven patients along with Eric Jonasch, MD shared their VHL stories to educate 45* representatives of the FDA and other federal agencies, including Deputy Commissioner for Medical and Scientific Affairs, Anand Shah, MD, about VHL and all 10 of its manifestations. Along with their VHL journeys, the speakers shared the long-term impact of VHL, which includes symptoms, manifestations, and the emotional toll on patients and their loved ones.


An FDA Patient Listening Session is a small, informal, non-regulatory, non-public discussions during which the disease experience is presented. The sessions are of interest to staff in multiple FDA Centers/programs and are focused on the disease experience. Discussion about a not a specific medical product (drug, biologic, or device) are prohibited.


A summary pdf from the VHL Patient Listening Session is available here.


A special thank you to the patient participants: Seth Horwitz, Brayden and Camron King, Maureen Neiteld, Michaela Thorne, Deanna Wickizer, Jaqueline Zarro, and Eric Jonasch, MD.


* Attendees

FDA Attendees

– Office of the Center Director
– Office of Tissues and Advanced Therapies
– Office of Tissues and Advanced Therapies, Division of Clinical Evaluation and Pharmacology/Toxicology

– Office of Product Evaluation and Quality

– Office of Oncologic Diseases, Divisions of Oncology 1 (DO1) and Oncology 2 (DO2)
– Office of Oncologic Diseases, Division of Hematology Oncology Toxicology
– Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Division of Rare Diseases and Medical Genetics
– Office of Neuroscience, Division of Anesthesiology, Addiction Medicine, and Pain Medicine
– Office of the Center Director, Professional Affairs and Stakeholder Engagement
– Office of Translational Sciences, Office of Biostatistics, Division of Biometrics V
– Office of Regulatory Operations

– Immediate Office of the Commissioner
– Patient Affairs Staff
– Office of Clinical Policy & Programs
– Office of Orphan Products Development
– Office of the Chief Scientist
– Oncology Center of Excellence

The Reagan-Udall Foundation for the FDA
NIH, National Center for Advancing Translational Sciences