FDA contradicts Trump admin, declines to approve generic drug for autism

Ars Technica
March 10, 2026
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1 min read

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The Bottom Line

FDA declined to approve a generic autism drug, contradicting earlier Trump administration claims.

How This Affects You

This decision clarifies that the generic drug leucovorin is not an FDA-approved treatment for autism, impacting treatment options.

AI Summary

The Food and Drug Administration (FDA) has declined to approve the generic drug leucovorin for autism, contradicting previous statements from the Trump administration. In September, FDA Commissioner Marty Makary had publicly suggested the drug could benefit a significant percentage of children with autism. Following these administration claims, a study in The Lancet reported a 71 percent increase in new outpatient leucovorin prescriptions for children aged 5-17 within three months. This FDA decision clarifies the drug's regulatory status despite prior governmental endorsements.

What's Being Done

The FDA declined to approve the generic drug leucovorin for autism, contradicting previous Trump administration statements.

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