The ‘3 Fs’ of social media compliance scrutiny

In an era where digital presence is increasingly vital, pharmaceutical companies face regulatory scrutiny from FDA and FTC, and legal liabilities around fair market value (FMV) concerns when engaging with social media platforms and partnering with influencers or digital opinion leaders (DOLs).

At a recent panel discussion at the Pharmaceutical Compliance Congress, Noah Goldstein, counsel at Porzio, Bromberg & Newman, and session moderator, said, “Social media coupled with influencer compliance is a complicated topic with a lot to discuss.”

Recent enforcement actions highlight the scrutiny these activities face. In 2024 alone, the FDA issued three untitled letters regarding celebrity or influencer drug advertisements, with particular focus on risk information presentation.

“The posts were misleading because they failed to present any of the side effect information with the same prominence that they talked about the benefits,” said Kaushal Rana, brand counsel at Takeda Pharmaceuticals, referencing an October 2024 FDA letter regarding an influencer post for Xeomin.

Another case involved Brittany Mahomes, wife of NFL quarterback Patrick Mahomes, who posted about an EpiPen-type product on Instagram. “There was absolutely no risk information presented whatsoever,” Rana said, adding that the FDA specifically emphasized this deficiency in their letter.PCC Panelists discuss influencer actions targeted by FDA.

Fair market value determination for influencers presents another challenge, particularly for healthcare professionals with significant social media following.

“It’s all about documentation,” said Jill Atstupenas, director of compliance for Syndax Pharmaceuticals. “It’s really when they’re the MD that it matters. It's doing the tiering, having additional tiering criteria for influencers on social media, and trying to pull out agency fees where you can contractually."

The panel also discussed the delicate balance of managing relationships with KOLs who post independently about company products. Rana advised: “If they’re not in a relationship with us, then you want to actually stay hands off. You don’t want to train them, and you let them post what they post.”

However, this hands-off approach comes with its own concerns. “It probably keeps me up a little bit at night — the idea that there could be an influencer out there that we don’t necessarily have a direct contractual relationship with but is talking to other doctors on social media about our drug,” Rana admitted. “I would almost rather have a relationship with that HCP. If I’m in enforcement or a regulator, my first thought would be, ‘Well, what are they getting then?’”

Read this article from the same panel.

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Header image: Depositphotos@AndrewLozovyi