Food and Drug Administration (FDA) commissioner Marty Makary on Friday said the agency has not finalized a forthcoming report about autism after the Wall Street Journal reported Health Secretary Robert F. Kennedy Jr. is expected to make an announcement linking Tylenol to the condition in children, urging mothers carrying children to forego the pain medication.
“The report is not written, so there’s nothing really to report, because we’re still in our discussions. I think the interest in Tylenol by The Wall Street Journal probably stems from the Harvard study on Tylenol and autism that came out recently,” Makary said during a Friday appearance on NewsNation’s “The Hill.”
“But our report is not yet written,” he added.
Makary said the president and Kennedy have made research about autism causes a “national priority.”
“We got to get to the bottom of it. There’s a lot of amazing research that we’re going through, and I think we’re going to have a pretty amazing report later this month,” he told host Blake Burman.
Kenvue, the parent company for the producer of Tylenol, did not immediately respond to The Hill’s request for comment on the matter.
However, a company spokesperson told the Journal, “Nothing is more important to us than the health and safety of the people who use our products.”
“We have continuously evaluated the science and continue to believe there is no causal link between acetaminophen use during pregnancy and autism,” the spokesperson added.
A 2024 report from the Journal of the American Medical Association found that Acetaminophen, the medication in Tylenol used to mitigate pain, was not associated with children’s risk of autism, ADHD, or intellectual disability in sibling control analyses when used during pregnancy.
Researchers noted that associations observed in other models may have been attributable to confounding.
Despite their findings, hundreds of lawsuits alleging the drug created disorders in children have been filed in court, the Journal reported. Still, Makary said the FDA would wait to receive more data addressing concerns before publishing updated guidelines for medicine usage.
“You know, we are incredibly data driven, so we’re looking at the Harvard study and the other study out of Duke, and we’re trying to analyze the magnitude and the weight of that data. But that is not the primary focus of this report,” Makary told Burman on Friday.
Kennedy has pledged to release a report about the causes of autism in September.
In recent weeks, Kennedy has faced intense scrutiny over his leadership and vaccine skepticism.
Eleven of the 12 Democrats on the Senate Committee on Finance have urged Kennedy to resign, while two of his family members made similar requests on Friday.
Republican lawmakers, including Senate Republican Whip John Barrasso (R-Wyo.), an orthopedic surgeon, also criticized Kennedy for his rhetoric surrounding vaccines, deeming some of his comments a threat to public health.
“I support vaccines. I’m a doctor. Vaccines work,” said Barrasso, the Senate’s No. 2-ranking Republican leader, said at a hearing this week.
“Secretary Kennedy, in your confirmation hearings, you promised to uphold the highest standards for vaccines,” he said. “Since then, I’ve grown deeply concerned.”
After Centers for Disease Control and Prevention (CDC) Director Susan Monarez was unexpectedly removed from leadership last week and four senior officials at the top public health agency resigned, lawmakers have raised questions about internal policies and practices under Kennedy.
“Americans don’t know who to rely on,” he said. “If we’re going to make America healthy again, we can’t allow public health to be undermined.”
