PULSE POINTS
WHAT HAPPENED: The Food and Drug Administration (FDA) plans to approve a new use for leucovorin to treat children with cerebral folate deficiency and autistic symptoms.
WHO WAS INVOLVED: FDA Commissioner Marty Makary, Health Secretary Robert F. Kennedy Jr., and President Donald J. Trump.
WHEN & WHERE: Announced on September 22, 2025.
KEY QUOTE: “In the coming weeks, the FDA will approve leucovorin as a treatment for children with cerebral folate deficiency and autistic symptoms.” – FDA Commissioner Marty Makary, National Institutes for Health (NIH) Director Jay Bhattacharya, and Centers for Medicare and Medicaid Services (CMS) Administrator Mehmet Oz
IMPACT: States will be required to cover leucovorin through Medicaid and CHIP once the FDA label change occurs.
IN FULL
The Food and Drug Administration (FDA) will approve leucovorin for treating children with cerebral folate deficiency and symptoms of autism. This move, announced on Monday, highlights the potential benefits of leucovorin, also known as folinic acid, which is already used for cancer and anemia patients.
The announcement was initially made by FDA Commissioner Marty Makary, National Institutes for Health (NIH) Director Jay Bhattacharya, and Centers for Medicare and Medicaid Services (CMS) Administrator Mehmet Oz, and underscored by President Donald J. Trump, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., and other officials at a Monday press conference on autism. They pointed to research suggesting the drug could aid children with folate deficiencies in improving verbal communication.
President Trump and Secretary Kennedy also stressed that they are recommending that pregnant women, in particular, should not take Tylenol, or acetaminophen (paracetamol), unless absolutely necessary, or give it to babies, citing potential links with autism. Use of ibuprofen, naproxen, and other nonsteroidal anti-inflammatory drugs during pregnancy is already discouraged due to the risk of birth defects.
President Trump is likely to get the greatest amount of pushback for his comments on vaccinations, saying they should be much more spaced out and stressing that the combined measles, mumps, and rubella (MMR) vaccine, in particular, should be taken in separate shots.
.@POTUS: “Just a few decades ago, 1 in 10,000 children had autism… now, it is 1 in 31… Since 2000, autism rates have surged by much more than 400%. Instead of attacking those who ask questions, everyone should be grateful for those trying to get the answers…” pic.twitter.com/uacGdsAARC
— Rapid Response 47 (@RapidResponse47) September 22, 2025
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