Autism Research and Policy Updates

Overview

A high-profile press conference led by President Trump and HHS Secretary Robert F. Kennedy Jr. announced new federal actions and updated medical guidance to address the rise in autism, focusing on research, medication use in pregnancy, and vaccination practices.

Autism Prevalence and Public Concerns

• Significant increase in autism rates over recent decades, with current estimates as high as 1 in 31 children.
• Concerns expressed about the economic, societal, and emotional impact on families and the nation.
• Calls for gratitude to those seeking answers and transparency around causes of autism.

Policy and Research Initiatives

• Launch of a cross-agency autism research initiative (NIH, FDA, CDC, CMS) to explore all potential causes, including environmental, pharmaceutical, and genetic.
• NIH announced the Autism Data Science Initiative with $50 million and 13 major new grants.
• Emphasis on rigorous, unbiased scientific methods, including exposomics and causal inference studies.
• Commitment to regular public updates and enhanced transparency.

Medication Guidance and Label Updates

• FDA to update warning labels for acetaminophen (Tylenol), citing potential links to increased autism and ADHD risk when used during pregnancy.
• Strong public health recommendation for pregnant women to avoid Tylenol unless medically necessary, using the lowest doses and shortest duration if needed.
• Nationwide public service campaign to inform physicians and the public of these risks.

Treatments and Coverage Changes

• FDA to update the label of prescription leucovorin for use in children with autism, specifically those with folate deficiency.
• Medicaid, CHIP, and likely private insurers to cover prescription leucovorin; CMS to monitor use and maintain data privacy.
• Assurance of increased production and distribution to meet potential demand.

Vaccine Recommendations

• Advisement to space out childhood vaccines across multiple visits rather than combining them in a single appointment.
• Recommendation to separate the MMR (measles, mumps, rubella) and chickenpox vaccines.
• Suggestion to delay the hepatitis B vaccine until age 12 unless medically necessary.

Community and Parental Voices

• Parents described the challenges of raising children at different points on the autism spectrum.
• Expressions of relief and gratitude for government attention and willingness to investigate potential causes.

Key Agency Statements

• HHS pledged to end siloed agency work and prioritize evidence-based over politically driven research.
• NIH and FDA affirmed commitment to accelerated, transparent, and parent-informed research pathways.

Questions and Clarifications

• Addressed differences between federal guidance and established groups (e.g., ACOG).
• Clarified leucovorin is not a chemotherapy, but a vitamin adjunct sometimes used in treatment.
• Confirmed ongoing communication with drug manufacturers to scale up leucovorin production.
• Statements emphasizing the importance of research into medication and vaccine safety.

Decisions

• FDA to update acetaminophen label warning for pregnancy.
• FDA to update leucovorin label for autism-related use.
• Medicaid/CHIP to cover prescription leucovorin for eligible children.
• NIH to fund and oversee major new autism research projects.

Action Items

• Immediate – FDA: Notify physicians of acetaminophen risks in pregnancy.
• Immediate – FDA: File label change for prescription leucovorin.
• Immediate – NIH: Initiate approved autism research grants.
• TBD – HHS: Launch public service campaign on medication risks in pregnancy.
• TBD – CMS: Convene states and research networks to support expanded study.

Recommendations / Advice

• Pregnant women should avoid Tylenol unless medically necessary and only under doctor supervision.
• Vaccines should be spaced out over multiple visits; avoid combining multiple shots when possible.
• MMR (measles, mumps, rubella) vaccine should be administered as separate shots, not combined.
• Hepatitis B vaccine should be delayed until age 12 unless at-risk.

Questions / Follow-Ups

• Ongoing studies required for conclusive data linking acetaminophen and autism.
• Additional research and guidance expected regarding vaccine administration schedules.

Key Dates / Deadlines

• NIH grants and funding to be allocated this calendar year.
• CMS grants for rural health and Medicaid research to be distributed by year-end.