Mitze Klingenberg expressed her devastation during an FDA town hall meeting after an FDA advisory committee voted against an experimental treatment for amyotrophic lateral sclerosis (ALS). She shared that her son, who benefitted from the treatment, was ignored and dismissed as anecdotal by the panel. Klingenberg emphasized the impact of false hope and the need for acknowledgment of patient experiences in such decisions. The meeting aimed to review advisory committee protocols and improve the agency’s use of committees. Klingenberg described the day of the vote as the second most difficult in their ALS journey, highlighting the importance of patient perspectives in regulatory decisions.
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FDA seeks public input on advisory committees
