Trump Tylenol Warning Kicks Off Label Change Drugmaker May Fight

Details of the FDA’s plan to modify Tylenol’s label to say it may be associated with a risk of autism in children will be crucial in determining when and how the painkiller’s manufacturer can dispute the change.

The Food and Drug Administration said it initiated the process for a label change to products containing acetaminophen, after President Donald Trump’s announcement Monday that warned about the unproven link between women’s use of Tylenol during pregnancy and autism in children.

Trump’s announcement on the medication, which has been long recommended during pregnancy to treat pain, fever, and aches, has spurred confusion for patients and pushback from medical organizations.

The FDA has yet to reveal how it plans to relabel products with acetaminophen. That process matters, because it can determine when Tylenol maker Kenvue Inc. can formally dispute and challenge the agency’s action—a move that’s likely given that the manufacturer has publicly disagreed with the government’s characterization of its product.

Kenvue didn’t respond to requests for comment on whether the FDA has engaged with the agency over label changes.

Prescription drugs and over-the-counter medicines go through different relabeling processes. While acetaminophen is found in hundreds of over-the-counter medicines like Tylenol, it’s also present in various prescription drugs used to treat moderate to severe pain. The FDA hasn’t clarified what its labeling change process will look like and if it will target both prescription and over-the-counter drugs.

“There’s a lot of different instances when a label change happens,” said Dominick DiSabatino, a partner on the life sciences team at Sheppard Mullin. However, “it’s kind of uncharted territory what they’re proposing to change here in terms of the label.”

“If you’re going to put a warning about an autism link, this isn’t like changing instructions,” DiSabatino said. “I would imagine there will be some measure of challenge if it ultimately happens.”

Relabel Process

Federal law allows the FDA to change a drug label if the agency determines that there is new safety information that should be included on the medication after it’s approved.

“Label changes are very often negotiated and not imposed,” said Peter Lurie, a former associate commissioner for public health strategy and analysis at the FDA, now president of the Center for Science in the Public Interest. “What’s different here, though, is that this seems to be pushed by the FDA without any real involvement of the company.”

The FDA engages in different processes when relabeling prescription or over-the-counter drugs, which each give manufacturers a chance to dispute the change at different times.

For over-the-counter acetaminophen, the FDA is expected to issue a proposed administrative order to change the label. The proposal is available for public comment for at least 45 days, which is then considered by the agency before it’s finalized.

In this process, Kenvue can dispute the order once it’s final and go through an administrative hearing and judicial review.

For prescription drugs with acetaminophen, however, the FDA is required to send a letter to the drugmaker notifying of new safety information and the need for a label change. The manufacturer can notify the FDA that it doesn’t believe a change is warranted and submit a rebuttal statement.

If the FDA doesn’t agree with the drugmaker’s rebuttal and the parties can’t reach a consensus, the agency can order the drugmaker to make the required labeling changes.

“We expect the agency will be reviewing evidence scientifically, but at the end of the day, they can take action even if the sponsor won’t do it voluntarily,” said Reshma Ramachandran, an assistant professor at Yale School of Medicine.

Industry watchers say the FDA is expected to go through the relabeling process that applies to over-the-counter drugs. If that’s the case, attorneys predict that Kenvue could act beyond the administrative dispute process and challenge the agency’s decision in court.

“My brain first goes to some sort of an Administrative Procedure Act claim—the agency has made some unilateral decision that’s adverse to someone’s interests, i.e. changing a label,” DiSabatino said.

“I can’t imagine there’s not going to be some kind of dispute although companies may view the FDA internal dispute resolution and hearing process as unlikely to involve the rigorous consideration of scientific evidence originally intended,” said Deborah Livornese, former senior regulatory counsel at the FDA’s Center for Drug Evaluation and Research.

“It will be interesting to see whether companies are going to think it is worthwhile pursuing something with the FDA internally or will wait until the order is final to challenge it in court,” said Livornese, now a director at Hyman, Phelps & McNamara P.C.

‘Backwards’ Move

Industry watchers are expecting Kenvue to dispute the relabeling, as the company has said there is “no proven link between taking acetaminophen and autism.”

Kenvue pointed to public health organizations including the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the Autism Science Foundation supporting its claim.

The FDA cited two large-scale cohort studies that suggest a link between acetaminophen use during pregnancy and autism—Nurses’ Health Study II and Boston Birth Cohort—but didn’t mention a much larger trial of 2.5 million people in Sweden that found acetaminophen was not associated with children’s risk of autism.

Medical experts are curious to know how Kenvue will respond to the FDA’s action that’s “based on evidence,” despite the agency stating that a causal relationship has not been established and there are contrary studies in the scientific literature.

“It’s interesting to see this because usually what happens is that FDA doesn’t announce they’re going to go through this process for a label change,” Ramachandran said. “What they usually do is accumulate the evidence they need to clear a case for it.”

“This is backwards,” Ramachandran said. “They’re announcing this process for making this change, and then they have the president and secretary go on national television and warn people to not take Tylenol.”