President Donald J. Trump and HHS Secretary Robert F. Kennedy, Jr. announced bold new initiatives to address the increasing autism spectrum disorder (ASD) crisis in the United States in the Roosevelt Room. The prevalence of autism has increased nearly 400% since 2000, and currently, one in 31 children in the U.S. lives with autism. Secretary Kennedy remarked that families have long lacked answers and choices, and these announcements aim to provide hope, support, and guidance. The strategy involves introducing new treatments, enhancing public health education, and funding research to understand autism better.
Among the measures is the FDA’s interference with leucovorin, which is administered to treat cerebral folate deficiency related to autism. The FDA will also update the drug’s label. This will be the first treatment for children with ASD approved by the FDA, and it is expected to show improvements in speech, social skills, or adaptive behaviour. With the support from the Centres for Medicare and Medicaid Services (CMS), state Medicaid programs will cover leucovorin for children who meet eligibility criteria.
The NIH will conduct confirmatory trials and safety studies to assess the effects of the drug. It is important to note that leucovorin does not cure autism. This treatment can only benefit a small group of children and must be administered under medical supervision, alongside other interventions like behavioural therapy. CMS Administrator, Dr. Mehmet Oz, stated that these measures offer new hope for the families and increase the limited options currently available to the children with ASD.
HHS will also address acetaminophen use during pregnancy. The FDA will provide physician guidance and possibly revise safety labelling based on the research suggesting a potential link between prenatal acetaminophen exposure and adverse neurodevelopmental outcomes. Because studies are not conclusive and untreated fever carries its own risks, clinicians are advised to use the minimal effective dose for the shortest duration. Other alternatives, such as NSAIDs, are hazardous during pregnancy. This project will develop a social awareness program to enable families to make informed choices and promote the importance of studying to save mothers and children.
Besides treatment and safety guidance, the NIH also reported the winners of the Autism Data Science Initiative (ADSI), and 13 projects are funded by the program (a total of over 50 million dollars). These initiatives will change research in autism by integrating biological, clinical, behavioural, and environmental data. The project will be conducted using advanced approaches, including machine learning and organoid models, and will involve parents, including both children and adults. Community engagement will be an integral part of the initiative, a fundamental aspect of research that ensures the initiative meets the needs of autistic individuals, their families, and clinicians. NIH Director Dr. Jay Bhattacharya said that the program has been founded on the most recent science to uncover the underlying causes of autism and come up with knowledge that can transform life.
FDA Commissioner Dr. Marty Makary highlighted that some children with autism may have low folate levels in the brain, which leucovorin can address. The initiative also promotes informed decision-making regarding acetaminophen use, helping families and medical professionals make safer choices. The new federal strategy combines treatment access, safety guidance, and research funding, providing hope, support, and resources to millions of American families affected by autism.
References:Â U.S. Department of Health and Human services. President Trump, Secretary Kennedy Announce Bold Actions to Tackle Autism Epidemic. Published September 22, 2025. Accessed September 23. 2025. President Trump, Secretary Kennedy Announce Bold Actions to Tackle Autism EpidemicÂ
