(WDNews) — President Donald Trump and U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced new steps Monday aimed at addressing what they called the nation’s autism epidemic.
Officials said autism rates have increased nearly 400% since 2000, now affecting 1 in 31 American children, according to the Centers for Disease Control and Prevention.
The U.S. Food and Drug Administration is moving to approve leucovorin, a drug currently used for cerebral folate deficiency, as the first FDA-recognized treatment pathway for children with autism spectrum disorder who show certain speech-related deficits. State Medicaid programs will be able to cover the treatment once labeling changes take effect. National Institutes of Health will also begin safety studies and clinical trials to confirm the drug’s impact.
“This is the first time families will have access to an FDA-recognized therapeutic for autism-related symptoms,” Kennedy said. “We will follow the science, restore trust, and deliver hope to millions of American families.”
Officials stressed the drug is not a cure and would apply only to a subset of children. Doctors will be advised to continue non-drug therapies such as behavioral treatment.
CMS Administrator Dr. Mehmet Oz called the move “an unprecedented, comprehensive approach” that gives families an option where few existed before.
At the same time, the FDA announced a safety review of acetaminophen use during pregnancy. Federal officials cited conflicting studies on potential links between prenatal exposure to acetaminophen and neurodevelopmental outcomes. The agency said it will update safety labels, encourage lowest-dose prescribing, and launch a national public awareness campaign.
“A growing body of evidence suggests that some children suffering from autism are folate deficient within the brain — a problem that can be treated with leucovorin,” FDA Commissioner Dr. Marty Makary said. “We are also sharing new information about acetaminophen so families can make more informed decisions with their doctors.”
The NIH also announced $50 million in funding for 13 projects under its Autism Data Science Initiative, which will use advanced tools such as machine learning and organoid models to study environmental, genetic, and social factors linked to autism.
“Millions of families need answers,” NIH Director Dr. Jay Bhattacharya said. “This initiative harnesses cutting-edge science to uncover root causes and improve lives.”
CDC data shows boys are disproportionately affected, with about 1 in 20 diagnosed. California reported the highest prevalence, with about 1 in 12.5 children affected.
