Tylenol Maker Goes On Offensive, Says Autism Warning Shouldn’t Be On Label
“For over a decade, and as recently as August, FDA has fully evaluated the emerging scientific evidence and repeatedly concluded that the data do not support a causal association” between acetaminophen and neurodevelopmental disorders, Kenvue told U.S. regulators.
Bloomberg:
Tylenol Autism Warning Should Be Rejected, Kenvue Tells US Regulators
Kenvue Inc. urged US regulators to deny a request warning against Tylenol’s use during pregnancy, laying out the most detailed defense of its biggest product after Trump administration officials tied its use to autism. A citizen petition filed last month asked for changes to the label “that are unsupported by the scientific evidence and legally and procedurally improper,” the company said in an Oct. 17 submission to the US Food and Drug Administration. The “overwhelming weight of the evidence” contradicts any claim that the nonprescription medicine used to treat pain and reduce fevers is a risk for neurodevelopmental disorders, the company said. (Brown, 10/20)
In other pharmaceutical news —
Stat:
CBO Says Revised Cost Of Orphan Drug Exemptions Will Add $3.9B To Medicare
The Congressional Budget Office has revised its forecast showing the recently enacted One Big Beautiful Bill Act will cost taxpayers as much as $8.8 billion — up from earlier estimates of $4.9 billion — over 10 years thanks to provisions that will exempt or delay certain drugs from Medicare pricing negotiations. (Silverman, 10/20)
Stat:
FDA Approved Fewer Drugs In Third Quarter, Analysis Finds
The upheaval at the Food and Drug Administration appears to be taking a toll on the pharmaceutical industry, according to a new analysis of key agency metrics. (Silverman, 10/20)
Fierce Healthcare:
WeightWatchers Teams With Amazon Pharmacy
WeightWatchers is joining forces with Amazon Pharmacy to make it easier for members to access weight management medications. The company announced Monday that through the partnership its members will be able to access information on real-time medication availability, automated coupon savings and home delivery for key medications they use to manage their weight. (Minemyer, 10/20)
Axios:
Walmart To Sell Abbott Lingo OTC Glucose Monitor In Retail First
Walmart will become the first U.S. retailer to sell an over-the-counter continuous glucose monitor in physical stores, as Abbott's Lingo rolls out to more than 3,500 locations and online, the health care company told Axios exclusively Tuesday. (Tyko, 10/21)
On marijuana and gun ownership —
AP:
Supreme Court Considers Gun Ownership For Marijuana Smokers
The Supreme Court said on Monday that it will consider whether people who regularly smoke marijuana can legally own guns, the latest firearm case to come before the court since its 2022 decision expanding gun rights. President Donald Trump’s administration asked the justices to revive a case against a Texas man charged with a felony because he allegedly had a gun in his home and acknowledged being a regular pot user. The Justice Department appealed after a lower court largely struck down a law that bars people who use any illegal drugs from having guns. (Whitehurst, 10/20)
