Claiming Your Drug Product Is Unique: Does That Mean It's Superior?

Brands and marketers seek to highlight what makes their products singular and unique. But it can be very challenging to do so in a manner that does not imply superior efficacy — particularly when evidence of superiority is lacking. The National Advertising Division of the CBBB (NAD) wrestled with this issue in a recent decision involving Nemluvio, a prescription drug approved by the Food and Drug Administration (FDA) for treatment of eczema. In a series of video advertisements, Galderma Laboratories highlighted the effectiveness of Nemluvio in treating itchy skin and claiming: "Works Like Nothing Before, Treating Eczema at Its Core." This claim and others were challenged by Sanofi, a competing pharmaceutical company.

NAD frequently reviews health-related claims, including those for FDA-approved prescription drugs, often noting that these are a priority and that the self-regulatory organization reviews these claims through competitor challenges and its own monitoring inquiries. According to Sanofi, by claiming that Nemluvio "Works Like Nothing Before, Treating Eczema at its Core," the advertiser was not merely demonstrating a unique product with the use of a clever rhyming scheme. Because "works like nothing before" was juxtaposed with an efficacy claim — "treating eczema at its core" — Sanofi argued that what was communicated to consumers was a drug product whose efficacy was superiorto competing products. NAD agreed and recommended that the claim be discontinued, finding that the advertising conveys the message that Nemluvio not only treats the root cause of eczema, but that it is theonly product that does so.

NAD then went further. Even though scientific evidence, in the form of clinical trials, supported the efficacy of the product, which was approved by FDA for treatment of moderate-to-severe eczema, NAD concluded that the claim, "treating eczema at its core," may suggest that there is a single core, root or underlying cause of eczema. According to NAD, eczema is a complex disease and the advertiser failed to support the claim that Nemluvio is the one and only FDA-approved drug that treats eczema at its core.

What is the lesson for advertisers? Many drug and consumer products are unique, and advertisers are surely entitled to say so in their advertising. But context is key, and when uniqueness is tied to efficacy or performance, the advertiser runs the risk of communicating a message that the product is unique because it outperforms others. In the absence of survey evidence, NAD may draw this conclusion based on its own review of the advertising at issue. The decision also illustrates that the FDA review and approval of a drug product does not necessarily insulate the advertiser from a challenge before NAD. NAD typically reviews advertising for a different purpose than regulatory agencies and evaluates the likely messages conveyed to consumers in the context of different platforms, including social media. Advertisers must consider not only the approved claims, but also the implied messages that may be conveyed.

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