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Drug industry groups target Hims & Hers Super Bowl ad touting weight loss drug
Drug industry allies are calling out a Super Bowl ad touting its weight loss medications from telehealth company Hims & Hers, claiming the spot doesn't adequately disclose safety risks of these drugs.
The ad criticizes the $160 billion weight loss industry and shows a person selecting the company's weight-loss offerings via smart phone. Although the ad does not identify the medication, Hims & Hers offers compounded versions of the weight-loss drug semaglutide, which was developed by Novo Nordisk and is typically sold under the names Wegovy and Ozempic.
The Partnership for Safe Medicines, a group consisting of more than 40 community and pharmacy groups, asked the Food and Drug Administration to "take action" and "protect Americans from misleading marketing in health products." The group also requested Fox, which will broadcast Sunday's game, to withdraw the "deeply troubling advertisement" before it airs Sunday.
Pharmaceutical Research and Manufacturers of America, a trade group representing drug manufacturers, said the ad violates a federal rule that requires drug ads not to be false or misleading. The ad has been posted on YouTube in advance of Sunday's title game between the Philadelphia Eagles and the Kansas City Chiefs.
Friday, Sens. Dick Durbin, D- Ill., and Roger Marshall, R-Kan., said in a letter to the FDA the ad risks misleading patients because it omits information about the drugs safety and side effects.
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Hims & Hers, which markets weight loss and other medications, said the company isn't a drug manufacturer and doesn't need to adhere to the same advertising standards. The San Francisco-based company connects customers to licensed health providers who perform an online evaluation and prescribe medications if appropriate. The company said it follows advertising requirements for telehealth platforms.
In a statement, Hims & Hers said the drug industry is attempting to cancel an ad 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."
Why are groups concerned about the ad?
In a letter sent Wednesday to the FDA, the Partnership for Safe Medicines said the 1-minute ad is "misleading in its entirety" because it doesn't disclose compounded drugs are not FDA approved and can be riskier for patients. The organization also challenged language that the drug was "formulated in the USA." Hims & Hers markets "knockoff versions of semaglutide – a drug that was formulated by Novo Nordisk following decades of research and billions in investment," the letter said.
Neither the FDA nor Fox responded to the group's letters as of Thursday afternoon, according to Shabbir Imber Safdar, the group's executive director.
In a statement Thursday, PhRMA said the ad doesn't cite potential risks and side effects from compounded GLP-1 drugs. The ad shows images of drug while describing the products as "life changing weight-loss medications" and "doctor-trusted," PhRMA said.
A worldwide audience is expected to tune into Sunday's matchup, a rematch of the tightly contested 2023 Super Bowl. Last year's game between the Chiefs and the San Francisco 49ers drew more than 123 million viewers with more than 202 million watching at least a portion of the game.
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Drug companies at odds with compounding pharmacies
Amid the Super Bowl ad dispute is a larger battle playing out between drug companies that market lucrative weight-loss drugs and firms that sell less expensive versions made by compounding pharmacies.
The FDA allows compounding pharmacies to sell copies of drugs when the medications are in short supply. But compounding pharmacies face stiffer restrictions when a drug shortage is resolved.
Hims & Hers markets compounded versions of Novo Nordisk's semaglutide, a medication that remains in shortage, the FDA said. Novo Nordisk sells the drug under the brand names Wegovy to treat obesity and heart disease and Ozempic to treat Type 2 diabetes.
In December, the FDA declared that Eli Lilly's weight loss and diabetes medication tirzepatide, sold under the brand names Mounjaro and Zepbound, was no longer in short supply. That means pharmacies have until Feb. 18 to discontinue "compounding, distributing or dispensing" tirzepatide. Suppliers that produce batches of the drug and sell to others have until March 19 to cease distribution.
Compounding pharmacies are regulated by state boards of pharmacy and source ingredients are usually obtained from factories registered with the FDA. However, the federal agency doesn't verify the safety or effectiveness of compounding pharmacies.