After holding a GBS Patient Listening session with the FDA in the Summer of 2020, the Foundation has continued to work with key leadership at the FDA to continue bringing the patient voice to their current work.
The FDA holds a very special role in the US healthcare system. Their job is to review and monitor the safety of the most important things we use every day; food, medicines, etc. The FDA is also extremely considerate of listening to patients and advocates on issues that affect them most. As a result, the GBS|CIDP Foundation has started to meet regularly with FDA leadership to relay some of what we hear from the community.
Most importantly, the Foundation has been working with the FDA to instill trust in the current global vaccination effort, especially for GBS|CIDP and variants patients. The FDA has assured us that safety is still the number one priority for all vaccines that are considered to be authorized for use in the US, and the Foundation will continue to work with both the FDA and the Global Medical Advisory Board to apply the science to our community.
Additionally, the Foundation relayed a recent common issue that we have heard, which is patients being refused a vaccine dose because of their current or past health status, specifically people who had GBS in the past. The FDA was very concerned to hear about this practice and reiterated that there is neither evidence in the research so far nor any specifications on the safety labels of the current vaccines that should prevent GBS, CIDP, or variants patients from receiving a vaccine dose if they so choose.
The FDA shared a phone number with the Foundation that patients may use to ask questions about vaccines or share their experience in obtaining one- or being turned away! You may call 1-800-835-4709 or email – firstname.lastname@example.org to access this service, and please email the Foundation at Chelsey.Fix@gbs-cidp.org when you cal/emaill the hotline so that we may follow up with the FDA on your issue.
Finally, the Foundation presented a plan for future engagement with the FDA, which included a potential future meeting that would allow patients living with CIDP to share their experience – stay tuned to learn more!
We are extremely excited about our continued relationship with the FDA. Please feel free to reach out and let us know if there are any specific issues you feel we should address.Need more resources? Join our community!