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This week, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) posted a warning letter (the “Letter”)[1], issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. (“Sprout”) and its CEO, Cindy Eckert (“Eckert”), regarding a social media post promoting ADDYI® (flibanserin) (“Addyi”). According to FDA, the now-flagged Instagram post, shared by Eckert, touted Addyi’s benefits but left out crucial safety information and important details on for the indicated population. There is a lot to unpack with this Letter and FDA’s manner of issuance, but as previewed in our prior blog posts this year, we believe this to be yet another example of FDA’s enhanced focus on drug advertising and promotion. Expect to see more warning letters—especially via social media advertising and promotion, actions directed at executives or personal social media accounts, and other creative ways the agency can push its mandate—in lieu of written regulation—to police the pharmaceutical industry.Continue Reading FDA Ratchets Enforcement on Social Media Promotion in New Warning Letter

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.Continue Reading Key Takeaways from FDA’s Latest Social Media Warnings