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FDA Faces Criticism Over Leucovorin's Autism Labeling Push

10/14/2025

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Summary

Story summary

In September 2025, Food and Drug Administration (FDA) Commissioner Marty Makary announced leucovorin's label for autism, claiming it could benefit many children.
In August 2025, FDA's drug center director George Tidmarsh led an inquiry into leucovorin for autism, spurred by Health Secretary Robert F. Kennedy Jr.'s interest in autism.
Facing pushback, Tidmarsh proposed pursuing an application for cerebral folate deficiency instead.
Health researcher Reshma Ramachandran criticized the process as contrary to FDA protocols.

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Story summary

In September 2025, Food and Drug Administration (FDA) Commissioner Marty Makary announced leucovorin's label for autism, claiming it could benefit many children.
In August 2025, FDA's drug center director George Tidmarsh led an inquiry into leucovorin for autism, spurred by Health Secretary Robert F. Kennedy Jr.'s interest in autism.
Facing pushback, Tidmarsh proposed pursuing an application for cerebral folate deficiency instead.
Health researcher Reshma Ramachandran criticized the process as contrary to FDA protocols.