FSR holds a Virtual FDA Patient Listening Session with over 50 FDA attendees

On April 21, 2022, The Foundation for Sarcoidosis Research (FSR) hosted a virtual Patient Listening Session on Pulmonary Sarcoidosis with the US Food and Drug Administration (FDA).   

FDA Patient Listening Sessions are small, informal, non-regulatory, non-public discussions from the patient perspective that seek to deepen the FDA’s understanding of a disease or health condition, the burden of the disease on those it impacts, and the challenges and barriers to effective diagnosis, treatment, and medical product development.  

Prior to this listening session, FSR surveyed its stakeholders, patient community, clinicians, researchers, and pharmaceutical companies and biotech to identify topics and challenges of pulmonary sarcoidosis with the highest priority.  Building on this feedback, FSR’s CEO, Mary McGowan, and Dr. Lisa Maier from National Jewish Health and an active member on FSR’s esteemed Scientific Advisory Board provided background on the greatest barriers to diagnosis, treatment, and the advancement of clinical trials. 

Six patients and one caregiver impacted by sarcoidosis shared their stories to highlight the challenges of misdiagnosis and of long diagnosis journeys. They recounted their daily struggles associated with living with sarcoidosis. They strongly urged the FDA to consider the critical need for drug development, and the necessity for more flexible clinical trials and approval pathways. 

“We are so thankful to our incredible patient speakers who provided the FDA with intimate and raw accounts of the difficulties associated with living with sarcoidosis,” said Mary McGowan.  “Through this listening session and our continued engagement with the FDA, we hope to be able to carve the path to increased clinical trials, the approval of more therapies, and improved patient outcomes.”  

The FDA attended with 50 representatives from 16 offices and 5 divisions. Participants in the listening session included: The Office of the Commissioner (OC), Office of Regulatory Affairs (ORA), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), and Center for Drug Evaluation and Research (CDER). 

Learn more about FSR’s FDA Patient Listening Session on Pulmonary Sarcoidosis by reading our summary white paper here.

Visit www.fda.gov/PatientListeningSessionSummaries to learn more.

FSR will host a webinar on August 3 at 5pm CT where you can learn more about this event and next steps.  This session was made possible by The Gies Foundation.