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A weight-loss drug commercial that ran during Sunday’s Super Bowl is deliberately misleading and the products it advertises are potentially dangerous, according to the nonprofit coalition Partnership for Safe Medicines and Sens. Dick Durbin (D-IL) and Roger Marshall (R-KS).  
 
What’s going on: “The minute-long ad … pitches a ‘life-changing’ solution … [of] weight-loss drugs, as offered by the telehealth startup Hims & Hers,” The New York Times (subscription) reports. “Viewers see a fridge stocked with Hims & Hers–branded vials of medications. These are compounded drugs, meaning they haven’t gone through the traditional approval process designed to safeguard against risks to consumers—a point the ad largely glosses over.”  

• Last Friday, Sens. Durbin and Marshall—who said they plan to introduce bipartisan legislation aimed at combating misleading advertising of compounded pharmaceuticals—told the Food and Drug Administration the ad “risks misleading patients by omitting any safety or side effect information when promoting a specific type of weight loss medication.”   

Requirement double standard: The makers of FDA-approved drugs are required to disclose their medication’s indicated uses and most significant risks and side effects, and “they’re prohibited from overstating benefits beyond the evidence or advertising off-label uses,” according to STAT (subscription). 

• In contrast, “advertising of compounded drugs is not subject to any of the advertising regulations that are typically applicable to prescription drugs,” pharmaceutical drug marketing consultant Dale Cooke told that publication.  

Necessary disclosures: As a result, the makers of compounded medications, including Hims & Hers, underrepresent their products’ risks, “potentially endanger[ing]” people, Partnership for Safe Medicines Executive Director Shabbir Safdar said in a statement.  

• Compounding has its place, as it “can help in individual circumstances, like allergies to a drug ingredient or in emergency shortages. But nationwide ads encouraging millions of people to buy and consume compounded injectables that aren’t FDA-approved undermines public health and safety.”  

Marketing parity: “[T]here should be no disparity in pharmaceutical advertising requirements between regulated entities,” the senators said in their letter to the FDA. They added that the agency should “take enforcement action against marketing that may mislead patients about this company’s products.”