I AM ALS calls on the FDA to allow video testimony of participants for the upcoming NurOwn AdComm hearing

I AM ALS
1200 Pennsylvania Ave NW #14135
Washington, DC 20044

U.S. Food and Drug Administration
Dr. Robert Califf
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Dear Commissioner Califf,

I am the CEO of I AM ALS, an organization created and driven by individuals affected by ALS. Our entire community is grateful and appreciative for the upcoming Advisory Committee meeting on NurOwn on September 27. Thank you for listening, hearing, and appreciating the passionate voices of the ALS community.

I am writing today, however, to share significant concerns about the FDA’s decision not to allow Zoom video testimony from the public during the meeting.

We believe shutting out the faces of those impacted by ALS will not allow for the transparent discussion you intended. Denying the visibility of the daily challenges of ALS patients strips away the chance for any authentic engagement, diminishing and devaluing any moment to be accurately seen and heard before this committee. We are incredibly concerned about how this limitation will significantly reduce the critical patient perspective and voice.

Not allowing video testimony from the ALS community significantly dehumanizes any patient contributor, but for a person living with ALS who may have already lost their voice due to the progression of the disease, this decision is cruel. Commissioner Califf, knowing your history of being a strong advocate for patients’ voice and input, we urge you to reverse this decision and allow those living with ALS to not only be heard, but seen and valued as significant contributors to this important proceeding.

We strongly encourage you to reverse this decision and allow the ALS community to turn their camera on for their video testimony at this hearing, giving the same respect and representation provided to the public speakers at the Cardiovascular and Renal Drug Advisory Committee that went before the FDA just yesterday. To not allow our community the same opportunity would be discriminatory and a failure of including an important component of the discussion to occur for so many living with or caring for a person living with ALS. We firmly believe that this policy should be standard across the agency.

I AM ALS thanks you for this consideration and hopes you will permit the use of video with their audio testimonies allowing public presenters to be heard and seen as their true and authentic selves. Please reach out with any questions.

With sincere appreciation,