Dr. Jeffrey A. Singer practices general surgery in Phoenix and is a senior fellow at the Cato Institute.

President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. announced Sept. 22 what they called “bold actions to tackle autism epidemic.”

It’s certainly bold to label the rise in autism diagnoses as an “epidemic,” considering that the definition and diagnostic criteria have broadened from autism only to include autism spectrum disorder, a broader category affecting more people. Also, increased awareness and screening among clinicians, educators and parents have resulted in more children being diagnosed.

However, the issue is real and requires investigation into its causes, prevention and treatment. But introducing government bureaucrats’ biases into the research process is not only unhelpful – it could distort the research agenda and hinder progress.

Let scientific research work. Keep federal government out of it.

For example, Kennedy wants to place a public label on bottles of acetaminophen (Tylenol and similar products), warning pregnant women that its use during pregnancy is associated with their children exhibiting autism.

While a systematic review published in August of 46 scientific studies found that most of them saw an association between prenatal acetaminophen and neurodevelopmental disorders (a broad category that includes autism), a study of nearly 2.5 million children born in Sweden between 1995 and 2019, using sibling controls, found “no evidence that acetaminophen use during pregnancy was associated with autism … or intellectual disability,” and concluded that acetaminophen during pregnancy was “not associated with children’s risk of autism, ADHD, or intellectual disability.”

The American College of Obstetricians and Gynecologists highlights more than 20 years of research on this issue. It states there is no link between acetaminophen use during pregnancy and autism or other neurodevelopmental disorders. It also emphasizes that untreated fever during pregnancy poses risks, and the benefits of treating it with acetaminophen outweigh these risks.

It's also important to consider other pregnancy-related factors. For example, advancing maternal age is linked to autism. More women have been having children later in life. According to a March 2025 Centers for Disease Control and Prevention report, more than 1 in 5 births in 2023 were from women over age 35.

Many substances, including alcohol and tobacco, can harm a developing fetus. It’s reasonable to ask whether acetaminophen belongs in that category.

So far, the question has been pursued by independent clinical researchers, not government agencies. Once Washington decides the answer – by slapping on a warning label or funding research designed to prove a theory – it stops being science and starts being politics.

We’ve seen this before: The government’s “food pyramid” locked nutrition science into a flawed framework for decades. Kennedy’s acetaminophen crusade, combined with the National Institutes of Health’s Autism Data Science Research Initiative mentioned in the Sept. 22 announcement, risks steering research toward predetermined conclusions instead of open inquiry.

The scientific community is already doing its job. The federal government should keep its thumb off the scale.

Easing regulations on prescription medication could help

Currently, many clinicians prescribe leucovorin, a relatively safe drug, to children with autism to treat the folate deficiency that many of them have, with encouraging improvements in their autism symptoms.

Because the Food and Drug Administration has never claimed leucovorin is effective for treating autism, these prescriptions are called “off-label.” That’s legal, but insurers sometimes refuse to cover the cost. As a second “bold” proposal, Kennedy proposed fast-tracking a label change to fix this.

Here's an even bolder option: Kennedy can ask Congress to remove the FDA’s efficacy requirement altogether. Before 1962, drugmakers only had to prove a drug was safe and properly labeled.

The Kefauver-Harris Amendments that Congress established in the 1960s added efficacy rules, which can delay approvals for years. Yet once the FDA determines a drug is efficacious for one condition, doctors can legally prescribe it for dozens more.

Such “off-label” uses account for about 20% of prescriptions. Why make doctors wait for years to treat condition A, only to trust them to use their judgment for conditions B through Z? Skipping the efficacy hurdle could get treatments to patients far faster.

Of the two “bold” actions Kennedy announced, one risks forcing a conclusion about acetaminophen on a still-debating scientific community, while the other only half-embraces clinicians’ judgment. True boldness would be letting doctors treat and researchers investigate without interference.

The federal government should step back and let evidence, not politics, drive progress, because children with autism benefit from answers, not edicts.

Jeffrey A. Singer, MD, practices general surgery in Phoenix and is a senior fellow at the Cato Institute. His latest book is "Your Body, Your Health Care."

This article originally appeared on USA TODAY: Trump, Kennedy overreach on Tylenol but don't go far enough on drug regulations | Opinion

Reporting by Dr. Jeffrey A. Singer / USA TODAY

USA TODAY Network via Reuters Connect