In the Law360 article “Key Takeaways From FDA’s Latest Social Media Warnings,” Sheppard Mullin FDA Regulatory attorneys Dominick DiSabatino, Cortney Inman and law clerk Julian Klein cover the FDA’s Office of Prescription Drug Promotion October 31 untitled letter to Merz Pharmaceuticals GmbH regarding the social media promotion of Xeomin, an injectable for improving glabellar lines. The FDA critiqued the video on Xeomin’s Instagram account, noting misleading risk and efficacy presentations.
The letter underscores the FDA’s continued emphasis on the “consistent with label” (CFL) guidance, emphasizing the importance of this enforcement agenda for the agency. The letter appears also to signal a policy shift in expectations for safety presentation in short-form social media content, suggesting the need for integrated and prominent risk information, which is based in part upon the research work that OPDP has done over the years in consumer perception of media more generally. And more curiously, the letter underscores that superiority claims may be broadly inferred.
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