Send a message to the FDA
Hearing directly from people affected by EPP and XLP matters. Personal messages help the FDA understand the lived experience behind the data and the real-world impact of delay.
If you choose to write, focus on your experience as a patient, caregiver, or family member. The most effective messages are specific, respectful, and centered on what this disease means in daily life.
What to include in your message
Explain your lived experience with EPP or XLP, or how it affects someone you love.
Describe what treatment delays mean in real life, such as pain, missed activities, isolation, loss of independence, parenting challenges, school or work limitations, and reduced quality of life.
Share why timely evaluation of therapies matters to you and your family.
Be specific, respectful, and focused on the patient experience. That is often what helps decision-makers understand what is at stake.
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Dear FDA Leadership,
I am writing regarding the February 13, 2026 Complete Response Letter for bitopertin for the treatment of EPP and XLP.
For people living with these rare diseases, delay means more pain, more isolation, and more life on hold. Patients do not have time to wait unnecessarily for a treatment that could make a meaningful difference.
I urge the FDA to apply the urgency, flexibility, and rare disease focus needed to move bitopertin forward as quickly as possible. Please keep the lived experience of patients and the seriousness of unmet need at the center of this process.
Sincerely,
[Your Name]
FDA Contact Information
Direct your letter to the Public Engagement Staff:
Email: publicengagement@fda.hhs.gov
Write to:
Public Engagement Staff
Office of External Affairs
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Ave WO32-5367
Silver Spring, MD 20993
United States
Social Media: You can share your story and tag the FDA and the FDA Commissioner. Messaging, hashtags and details for posts are available here.