The recent Super Bowl advertisement by telehealth company Hims & Hers has sparked significant controversy, drawing eye-catching attention for its promotion of compounded weight-loss medications, particularly GLP-1 agonists such as semaglutides. Critics are alleging the ad misled consumers by withholding key safety information, igniting debates over the regulation and approval of compounded medications.
Hims & Hers positioned itself as the anti-establishment choice against "Big Pharma," claiming to offer affordable solutions amid rising healthcare costs. The ad featured the slogan "Sick of the System" and suggested their services as alternatives to traditional pharmacies. Despite their compelling narrative, critics argue the commercial fails to adequately inform viewers about the nature of the medications it promotes.
At the heart of the backlash against the advertisement is the distinction between compounded medications and their FDA-approved counterparts. Unlike brand-name or generic drugs, compounded medications are made without the stringent regulations governing their production and safety. According to Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, "By mass marketing and mass producing compound medications, we are devolving the safety of our drug supply." This sentiment has raised alarms about the quality and control of the medications offered by companies like Hims & Hers.
Viewers of the ad noted the small disclaimers indicating the compounded drugs are not FDA-approved, which some failed to catch due to the print style and color used, which placed the information against the white and gray backgrounds of the advertisement. This drew ire from experts who noted the omission of required safety information typical for FDA-approved medications, such as possible side effects and contraindications.
The lack of clarity surrounding the medications is particularly concerning as the FDA has reported instances of patients being hospitalized owing to dosing errors with compounded drugs. These medications lack the distinct serial numbers tied to their manufacturers, heightening the risks associated with their use. Safdar explained, "A big problem, if a compounding facility makes you a drug prescribed by a doctor you've never met, is you're now holding a vial you're expected to inject, and there’s actually no way to know where it came from."
The Hims & Hers advertisement highlights these compounded medications and positions them as accessible and inexpensive alternatives to traditional therapies. While brand-name Ozempic and Wegovy can cost as much as $1,799 monthly, Hims & Hers offers compounded semaglutide for just $165. The company claims their products come only from FDA-regulated bulk outsourcing facilities, but experts like Safdar argue this system was never devised for the mass marketing and wide-scale usage portrayed by the Super Bowl ad.
Attention has also come from lawmakers following the outcry. Senators Richard Durbin (D-IL) and Roger Marshall (R-KS) expressed concerns over the regulatory loopholes allowing such advertising tactics. They released statements supporting the introduction of bipartisan legislation aimed at closing gaps within the FDA's authority, emphasizing the need for safety and transparency around compounded medication practices. "To the extent this falls within a regulatory loophole... we plan to soon introduce bipartisan legislation to close this gap," the senators stated.
Hims & Hers maintains they are acting within safety regulations and offer patients tools to verify their medication's integrity through testing displayed on their app. Dr. Craig Primack, the company’s senior vice president of weight loss, reassured the public, stating, "Patients can check the testing related to their batch of medication on the company's app," which details aspects like bacterial contamination and correct drug concentrations.
The Super Bowl ad has sparked discussions about the balance between accessibility of medications and ensuring patient safety. While compounding medications play important roles, such as for those with drug shortages or specific needs—"We need compounding," Safdar stated—the unregulated extent to which companies market compounded drugs raises pressing questions about consumer responsibility to navigate the complex healthcare options available. The effectiveness of efforts from Hims & Hers will likely be examined as the legislative proposals urged by lawmakers progress.
With the advertisement highlighting these compounded medications, we may see shifts within legislative discussions about how compounded drugs are marketed and regulated. The controversy surrounding Hims & Hers may prompt greater scrutiny of not only their practices but also the broader industry, reflecting growing public concern over safety and transparency in healthcare advertising.