Operating at full capacity thus far this year, the U.S. Food and Drug Administration (“FDA” or “agency”) Office of Prescription Drug Promotion (“OPDP”) has so far released seven untitled letters, reminding the industry that the agency continues to watch direct-to-consumer television ads closely. While there are no new central, unifying themes from the most recent batch issued to Sobi, Inbc., Novo Nordisk Inc., and argenx US, Inc.—there are two “buckets” of issues FDA flagged that are worth noting: (1) perceived oversimplification of administration instructions, and (2) taglines/creative allegedly incongruent to the clinical outcomes. While some of these interpretations may be challengeable from a legal standpoint, they offer insight into the agency’s current mindset regarding broadcast media.
The Pitfalls of “Simplifying” Administration
The second bucket concerns communications about the patient experience, specifically. administration and the physical reality of treatment. In the argenx letters for VYVGART HYTRULO®, the FDA flagged the “oversimplification” of the drug’s administration process. For anyone that has built advertising campaigns for complex administration drugs, in the quest to make a therapy appear patient-friendly and accessible, there is a recurring risk of glossing over the nuances of the injection process or the associated risks reactions.
Like all things, we search for the line that FDA would deem sufficient without literally repeating the entirety of the Instructions for Use. In short, these letters suggest that when a claim reduces administration to a single time-to-inject soundbite—or pairs administration messaging with “on-the-go” visuals—OPDP may view that combination as crossing into misleading simplification.
Creative Taglines vs. Clinical Reality
It comes as no surprise that the agency continues to scrutinize aspirational messaging and audio/visual “vibes” created by clever branding. In the letter to Sobi regarding its VONJO® product, the FDA took aim at the tagline “turn the page.” On the nose, the metaphor evokes the start of a new chapter. However, while the point here is not venture into the weeds on the therapeutic space, the product occupies a specialize niche of therapy, considered after trying other therapies. Unfortunately, the FDA viewed this through a rigid lens and, with lean evidentiary discussion, found the ad suggested a holistic impact on health-related quality of life that was not supported by one of the pivotal trial’s two primary efficacy endpoints—but to be sure, there was data clearly supporting the tagline.
A similar, and arguably more aggressive, stance appears in FDA’s letter to Novo Nordisk for WEGOVY®. The agency zeroed in on the tagline “Live Lighter,” arguing that the totality of the claims and presentations misleadingly suggested that the dosage form somehow offered a clinical advancement or improvement over other approved GLP-1s. This one is a head-scratcher because these products—regardless of their approved formulation—lead to weight loss, and therefore, “living lighter” (and healthier across a variety of proven metrics). Alas, the FDA seems hyperfocused on the use of the turn of phrase “now you can” to draw its conclusion, which is thin logic that could be easily attacked.
These letters highlight a persistent challenge for the industry—at what point does a creative metaphor become an actionable misrepresentation in the eyes of the FDA? While one might argue the FDA is flying too close to the sun on all this enforcement, the practical reality is that the agency is increasingly allergic to any exciting narrative because it appears to believe advertising is a de facto vehicle to outpace the specific metrics found in the labeling.