As an organization representing young adults with chronic and rare conditions, we are deeply committed to ensuring our community has affordable access to prescription medicines. We are dismayed by Hims & Hers' recent Super Bowl advertisement announcement, which co-opts the narrative about affordability without adhering to the integrity standards expected of prescription medicine advertising. Specifically, the advertisement fails to display the safety profile of GLP-1s alongside their efficacy, a core requirement for prescription drug advertisements. Other important information is brushed off, including fine print that these compounded versions of the GLP-1s are not FDA-approved, essentially omitting key information that patients deserve to have explicitly.
The regulations put out by the FDA, even as they become more up-to-date, have emphasized the importance of fair balance and prohibit false or misleading prescription medicine advertisements. A grey area emerges when compounded versions of prescription medicines, which are not FDA-approved, seemingly bypass these rules. We ask that the FDA clarify and ensure that compounded drug versions are not exempt under Section 502(n) of the Food, Drug, and Cosmetics Act.
This advertisement's approach makes it challenging for patients like us to get the full story, seriously downplaying the complexity of these medications. It is integral for advertisements to clearly display crucial safety and efficacy information so patients can feel empowered to make informed decisions about their health.
We acknowledge that prescription medicines are often unaffordable, with roughly 18 million Americans struggling to afford their medications. While the advertisement rightly addresses this concern, the price offered by Hims & Hers remains significant, especially considering this treatment is designed for lifetime use. In the case of obesity, GLP-1s have shown beneficial impacts and offer an option for those who choose it. However, Hims & Hers has focused solely on affordability for their compounded therapeutic, seemingly obscuring that these are serious chemical compounds that require full disclosure of efficacy and safety information.
The FDA must investigate Hims & Hers Health before this advertisement reaches over 120 million people during the Super Bowl. We urge Hims & Hers Health to modify their advertisement to comply with FDA’s regulations or remove their advertisement and stand ready to assist in ensuring fair and comprehensive information is shared with such a large audience.
Given the regulatory grey area, Congress should also focus efforts this season on the Protecting Patients From Deceptive Drug Ads Act (see our plain language description here), which would clarify that compounders must follow the same rules for FDA-approved prescription medicines. We also call on pharmaceutical companies to promote the affordability of their therapeutics, recognizing the critical need for more accessible prescription medicines.
For more information or to contact us about this work, please email admin@generationpatient.org.