Regulatory NewsBREAK: President Trump Makes Announcement on Autism

• On September 22, 2025, President Trump claimed that acetaminophen, the active ingredient in Tylenol, taken during pregnancy increases the risk of autism. Acetaminophen has long been considered one of the few safe options for treating pain or fever during pregnancy.  
• The President advised pregnant women to only use acetaminophen if medically necessary for extremely high fevers. Secretary Robert F. Kennedy, Jr. of the Department of Health and Human Services (HHS) announced that the Food and Drug Administration (FDA) will advise against acetaminophen use during pregnancy and said it should only be taken if medically necessary at the lowest effective dose for the most limited duration.  
• The President advised against giving children Tylenol for pain from a vaccination.  
• The President also made several statements about vaccines, including advising against hepatitis B vaccines for children under 12 years of age and suggesting that the measles, mumps, and rubella (MMR) should be administered as three separate shots. The administration did not announce specific government actions related to these statements.
• The administration suggested that leucovorin, a cancer and anemia drug, may be a potential therapy for some patients with autism. FDA scheduled a notice for the Federal Register to announce that FDA is approving a previously withdrawn New Drug Application (NDA) for Wellcovorin (leucovorin calcium) tablets.
• Dr. Jay Bhattacharya, Director of the National Institutes of Health (NIH), discussed autism research that NIH is planning through the Autism Data Science Initiative (ADSI).  
• Dr. Marty Makaray, Commissioner of the FDA, announced that FDA will issue a physician notice and begin the process to initiate a safety label change for acetaminophen.  
• Dr. Mehmet Oz, Administrator of the Centers for Medicare and Medicaid Services (CMS), stated that state Medicaid and the Children’s Health Insurance Program (CHIP) will cover leucovorin with a prescription.

More on This Topic:

• White House Statement
• Press Release
• Fact Sheet
• Approval of Previously Withdrawn NDA for Wellcovorin (leucororin calcium) Tablets

For questions, please reach out to Vicky Jucelin.