The US Food and Drug Administration unexpectedly approved a medicine to treat autism, upending the usual process and raising concerns of political interference in drug approval.
Leucovorin is already used on chemotherapy patients, but some advocates believe it can reduce autism symptoms; small trials suggested it can improve verbal communication.
Normally, drug manufacturers apply for approval, but this time the FDA commissioner declared the approval unexpectedly during US President Donald Trump’s comments linking the painkiller acetaminophen to autism.
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The condition has become a main focus for the administration, especially Health Secretary Robert F. Kennedy Jr, who believes increases in the prevalence of autism are linked to environmental causes. Most researchers say the growth comes from increased awareness and changing diagnostic criteria.
