| The long-running legal fight over Tylenol and autism claims is going back to court. A three-judge federal appeals panel on Monday revived hundreds of lawsuits alleging that taking acetaminophen, the active ingredient in Tylenol, during pregnancy may be linked to neurodevelopmental disorders. The 2nd U.S. Circuit Court of Appeals said a lower court went too far when it tossed out testimony from some of the plaintiffs’ expert witnesses who argued prenatal acetaminophen exposure could contribute to ADHD and autism in children. Ashley Keller, an attorney representing some of the families suing Tylenol-maker Kenvue and a collection of retailers and pharmacies, called the ruling a “vindication” of the scientific evidence they have presented. The appeals court said it was not weighing in on the ultimate scientific question or whether manufacturers must warn consumers about any alleged risk. But it found that a trio of the plaintiffs’ experts — Harvard School of Public Health Dean Andrea Baccarelli, Albert Einstein College of Medicine psychiatry professor Eric Hollander and Columbia University toxicologist Brandon Pearson — used methods consistent with accepted scientific approaches. “The Court of Appeals agreed that our experts’ analyses of the voluminous research linking prenatal acetaminophen exposure to neurodevelopmental disorders is reliable. We look forward to presenting that evidence to a jury,” Keller, a founding partner of Keller Postman, said in an emailed statement. A lower-court judge dismissed roughly 500 lawsuits in December 2023, while questioning the methodology used by plaintiffs’ experts, claiming they had “permitted cherrypicking, allowed a results-driven analysis, and obscured the complexities, inconsistencies, and weaknesses in the underlying data.” → The issue exploded into the political spotlight last September, when President Donald Trump, flanked by top health officials, warned pregnant women against using acetaminophen. Many medical experts have found no established link between the over-the-counter drug, which is often used as a fever reducer, and autism. Medical professionals including the American College of Obstetricians and Gynecologists have cautioned that untreated fevers during pregnancy can carry their own risks, while emphasizing Tylenol’s safety. A Kenvue spokesperson said the ruling “does not change the fact that credible, independent science shows no proven link between taking acetaminophen and autism or attention-deficit hyperactivity disorder.” “Science matters, and we stand with the many public health and medical professionals who have reviewed the science on this topic and agree,” the company spokesperson said in an emailed statement. “We now have another opportunity to show that the plaintiffs’ experts’ opinions are unreliable and should not be allowed in this case. We stand behind the safety of our product and will continue to defend these cases.” What to watch: The appeals court decision notes that there have been “numerous relevant studies on this issue [that] have been published” since the last court decision. “The district court may consider it prudent to invite the parties and their experts to address those new studies,” the three-judge appeals panel wrote. The House Energy and Commerce health subcommittee is set to have a hearing Wednesday about how the Food and Drug Administration can speed up early-stage drug development amid growing concerns that the United States is losing its edge in biomedical innovation. Lawmakers are focused on the agency’s role in maintaining U.S. leadership as more preclinical and early-stage clinical research shifts overseas, particularly to China and Australia, according to a hearing memo released by the panel. China is projected to account for roughly 35 percent of FDA drug approvals by 2040 — up from just 5 percent in 2025, according to an analysis by Morgan Stanley. → The discussion builds on the recently launched Operation TrialBlazer initiative, a multiagency effort by the Trump administration that aims to accelerate domestic clinical research and strengthen U.S. competitiveness in drug development. What to watch: It also comes as lawmakers begin laying groundwork to update the law that sets fees that drug manufacturers pay to the agency. Those user fees expire, unless Congress acts, in 2027. That legislation has historically served as a vehicle for FDA policy reforms. One of the experts testifying before the panel, Thomas J. Bollyky of the Council on Foreign Relations, talked about the issue at a Washington Post Intelligence briefing last Friday. “The reality is, the U.S. is not just losing clinical trial activity to China; it’s losing it to places like Australia and Norway as well,” Bollyky said. The Trump administration’s reforms, he said, “borrow some of the good innovations from those settings.” However, he pointed out, Operation TrialBlazer is made up of “proposals, nonbinding draft guidance, requests for information [and] voluntary pilots, as opposed to final and binding law.” “I want to temper expectations a bit because we’re still at the early days of this. It’s a really positive step, but there’s a lot the agency has to do to get its own house in order,” Bollyky said. | 
