One of the largest compounders in the U.S., Hims & Hers, is spending millions of dollars to run a misleading Super Bowl ad that misrepresents their unapproved GLP-1 medicines.
The ad runs afoul of the Federal Food, Drug, and Cosmetic Act (FDCA), which requires that advertising for prescription drugs—including compounded drugs–not be false or misleading.
It also resurfaces serious concerns about the lack of oversight of the compounding industry, specifically that these products don’t undergo the same extensive FDA review for safety and effectiveness. At the same time, the way these products are advertised and marketed violates the stringent requirements imposed on advertising for all products.
Here are a few examples of how the Hims & Hers ad is misleading, deceptive and misbrands their unapproved products.
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The ad entirely omits risk information, failing to provide fair balance. The ad doesn’t include any information about the risks and side effects associated with the compounded GLP-1 drugs displayed in the commercial and marketed across the Hims & Hers platforms. The ad shows vials and pills, which appear to be the compounded GLP-1 products offered on Hims & Hers website, and includes benefit claims, describing the products as “life changing weight-loss medications” and “doctor-trusted.” However, the ad does not include any safety or risk information to balance the benefit claims, which presents a misleading impression that unapproved compounded GLP-1 drug products are safe and effective. This is especially problematic because the FDA has warned that compounded products pose a higher risk to patient safety than FDA-approved medicines.
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The ad claims Hims & Hers compounded GLP-1 drugs are safe and effective without any evidence. Compounded drugs don’t go through the rigorous FDA review process to evaluate their safety, effectiveness and quality. For Hims & Hers compounded GLP-1s, no major clinical studies have been reported to substantiate their safety or efficacy. Yet, the ad includes claims that falsely imply that their unapproved compounded drug products have been demonstrated to be safe and effective. Absent data, these claims are unsubstantiated, misleading and deceptive.
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The ad fails to clearly and prominently disclose that the FDA has not approved or evaluated these products for safety, effectiveness, or quality. The ad does contain a brief disclosure that compounded drugs are not FDA-approved or evaluated for safety, effectiveness, or quality, but the text is too small and can be easily missed by the viewer. As a result, patients may be misled into believing that the products promoted in the ad are FDA-approved or reviewed by FDA for safety, effectiveness or quality. FDA requires text in pharmaceutical ads to be easy to read for consumers. For example, in recent guidance interpreting its regulations around presentation of risk information in television advertising, the agency outlined detailed recommendations to help ensure that textual information is “easily readable.”
The compounding industry’s trade association, which Hims & Hers is a member, recently released guidelines for how the compounding industry should and shouldn’t market their products. These guidelines clearly acknowledge that unless drugs are FDA approved for a particular use, they “cannot be promoted as safe and effective for treating that condition. This holds true for compounded medications…”
It’s worth noting that the Hims & Hers ad does virtually everything the trade association says compounders shouldn’t do to avoid “risk of action being taken against them” by regulators.
Compounders are subverting the FDA’s rigorous approval process while increasing the risk for patient safety and misleading the public, without accountability for running false and misleading ads like these.
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.
Nick McGee
Nick McGee is deputy vice president, public affairs, at PhRMA focusing on communications strategies and activities for the organization’s advocacy priorities.
Nick McGee
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Major drug compounder is spending millions on misleading Super Bowl ad
HimsHers ad