SUPER BOWL AD DRAWS INDUSTRY IRE — Advocacy groups representing the drug industry and pharmacists are calling on the FDA to rein in one telehealth platform’s Super Bowl commercial that they say crosses the line of what’s legally permissible to tout in pharma ads. At issue is a 60-second spot for the twin telehealth platforms Hims and Hers called “Sick of the System.” The ad criticizes drug companies for setting high prices for weight-loss medications — without naming the two manufacturers behind the biggest GLP-1s. “This system wasn’t built to help us. It was built to keep us sick and stuck,” the narrator says, echoing a common argument made by influencers in the Make America Healthy Again movement led by Robert F. Kennedy Jr., the president’s HHS secretary nominee. The commercial promotes “life-changing weight-loss medications” available through Hims that are “affordable, doctor-trusted and formulated in the USA” — a nod to the compounded GLP-1s that customers can access through the platform’s providers. For about three seconds, the ad displays — at the bottom of the screen, in tiny font — that compounded drugs “are not FDA approved” or evaluated for “safety, effectiveness, or quality.” Pharma’s take: The brand-drug industry lobby PhRMA slammed regulators for allowing the advertisement — calling it a “clear violation” of the Federal Food, Drug and Cosmetic Act’s requirement that advertising for prescription drugs not be false or misleading. “Compounders are subverting the FDA’s rigorous approval process and misleading the public with their advertising while regulators turn a blind eye,” PhRMA spokesperson Sarah Ryan said in a statement. “We urge federal and state regulators to conduct real oversight over compounders, including by ensuring that their advertising and promotion does not mislead patients or put them at increased risk.” The Partnership for Safe Medicines — a group that counts PhRMA and various state pharmacy associations as members — asked the FDA’s Office of Prescription Drug Promotion on Wednesday to “take action and stop Hims & Hers from misleading the 200 million people who will see this commercial if it runs during Super Bowl LIX.” As we’ve previously reported, the FDA’s authority to police telehealth platforms’ ads depends on how they’re structured. Hims’ response: “This is a clear attempt by industry groups to cancel an advertisement that directly calls out how they are part of a system that fails to prioritize the health of Americans. The system is broken, and this is just another example of how they don’t want Americans to know they have options.” FDA’s response: An FDA spokesperson said the agency monitors “promotional materials” for all drugs, including compounded medications, “and takes this responsibility seriously.” “If the FDA has concerns that promotional materials are false or misleading, the FDA may take action to seek compliance from the manufacturer, packer or distributor responsible for the promotional material,” the spokesperson said in an email. “Determinations about whether such action is appropriate are dependent on the facts and circumstances relevant to each matter.” KENNEDY PROCEDURAL VOTE — Robert F. Kennedy Jr. is one step closer to becoming the head of all federal health agencies after a key procedural vote Thursday night. The Senate voted 52-47 to move to executive session on Kennedy’s nomination, setting up a confirmation vote next week. Kennedy still has to clear two more votes in the coming days to become Health and Human Services secretary as Democrats used delaying tactics permitted under Senate rules, indicating their particular displeasure with the Kennedy nomination. Still, it’s been all but certain Kennedy will be confirmed as HHS secretary since Tuesday when Republican senators on the Finance Committee united to move his bid forward in a party-line vote. That included Senate Health, Education, Labor and Pensions Committee Chair Bill Cassidy (R-La.), a doctor who initially said he was “struggling” with Kennedy’s reluctance to disavow false claims about vaccine safety but then agreed to support Kennedy after receiving several assurances from him. During his confirmation hearings, Kennedy said he’d prioritize combating chronic diseases that he believes are the result of additives in the food Americans eat and pollution in the environment. He said health agencies have spent too much time and money on infectious diseases, allowing chronic diseases to grow.
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