Patients and caregivers have unique perspectives on the burdens and benefits of various treatment options. As such, their input is invaluable to the drug evaluation process. On April 3, 2018, Celiac Disease Foundation Legislative Analyst, Alana Broe, attended the FDA’s Public Workshop on Keys to Effective Engagement with the Center for Disease Evaluation and Research (CDER). Under legislative mandate, the FDA is seeking to increase the integration of patient experiences and perspective into its drug evaluation and approval processes. This ongoing effort by the FDA grants the Celiac Disease Foundation the opportunity to have a seat at the table in important discussions affecting celiac disease patients.
The Celiac Disease Foundation has already responded to this opportunity to engage with the FDA, and will continue to raise the voice of the celiac disease community in Washington, D.C. Earlier this year, the Foundation submitted comments on the FDA’s draft guidance to drug manufacturers regarding labeling of gluten in medication. Additionally, the Foundation has implemented programs to gather patient experiences and perspectives, including the Patient Advocacy Program and the celiac disease patient registry, iCureCeliac®. As the FDA reviews other issues relating to the celiac disease and non-celiac gluten sensitive community, the Celiac Disease Foundation is committed to engaging as an active participant in the process.
The Celiac Disease Foundation Attends FDA Engagement Workshop