Social media, influencers and digital opinion leaders

Regulatory and legal guidance around social media is in place, but compliance around direct-to-consumer interactions can still be an issue.

Last year, the FDA’s Office of Prescription Drug Promotion (OPDP) cited two pharmaceutical companies in warning letters regarding social media posts. The posts from kaleo and Merz Pharmaceuticals both included the mention of an influencer and made false misleading information about the benefits. They also failed to include any risks or misleading risk statements about the drugs.

In the kaleo case, AUVI-Q, a prescription for epinephrine injection used to treat life-threatening allergic reactions, a paid influencer—Brittany Mahomes, wife of Kansas City Chiefs quarterback Patrick Mahomes—posted on her personal Instagram account in paid partnership with AUVI-Q. The OPDP found that the short video post violated the Food, Drug and Cosmetics Act under Section 352, which addresses misbranded drugs and devices, because it mentioned no risks associated with the drug, only benefits.

Kaleo responded with its corrective action, and a close-out letter was issued by OPDP after the it verified the action.

In the Merz case, influencer Nate Berkus—an interior designer, author, and television personality—posted on his personal Instagram account in paid partnership with Xeomin Aesthetic. Xeomin (incobotulinumtoxinA) is a prescription injection used to improve the look of moderate to severe upper facial lines, and it also has a black box warning. The ODPD specifically called out the video featuring Berkus promoting the benefits and none of the risks. However, it did call out that the post at the very end discloses risks but basically says it’s unreadable and buries the lede.

The Merz letter was issued October 31, 2024, but does not yet have a close-out letter.

According to an article published on the Porzio, Bromberg & Newman website, both “FDA and FTC have been focusing on the use of endorsements and influencers on behalf of industry and other business areas.” The panel is expected to update attendees on how to implement guardrails around social media, discerning corporate, medical and commercial social media initiatives, monitoring social media, and more.

Direct-to-consumer interactions

In a recent webinar, Pharmaceutical Compliance: Emerging Trends & Best Practices for 2025, produced by the Pharmaceutical Compliance Congress, direct-to-consumer interaction was discussed, illustrating the need for continual evolution within the compliance function.

Katherine Norris, AnkuraKatherine Norris, senior managing director for consultancy Ankura, grouped these activities into sanctioned versus. unsanctioned interactions. Sanctioned interactions are those officially managed by companies through static postings on internet domains, as well as more dynamic engagements involving influencers and other representatives creating messages on behalf of the company. In contrast, unsanctioned interactions involve individuals sharing their personal experiences with drugs on internet platforms, potentially creating their own markets while simultaneously disseminating information about pharmaceutical products.

“We’re seeing a lot of activity in terms of internet monitoring that can keep a pace of that which is already out in the domain,” Norris said. However, she continued, “One of the biggest challenges is how to contain messaging once it’s already out in the public atmosphere. It can be very difficult to pull that back.”

Kelly Tope, head of ethics and business integrity governance, operations and risk management, North America and global specialty care for Sanofi, allowed that once something is managed appropriately, it can still go awry.Kelly Tope, Sanofi

“Even when you have a regulated message by the company that's been approved through all the channels, and they post on LinkedIn or Facebook or those types of social media sites, they’ll turn the comments off so people don’t complain or report adverse events in the comments, but they generally allow people to share those approved advertisements that are out there,” she said.

“When you share that, people can either put their own comments in, if it’s a patient who sees it on LinkedIn and shares it and they make their own comment … and if you don’t turn the comments off, people can report adverse events there, which trigger reporting responsibility. I think people need to carefully manage any of the social media posts, even the approved posts, and how you handle those."

At our upcoming Pharmaceutical Compliance Congress, the topic of social media, influencers, and digital opinion leaders will be discussed.

Header image: Depositphotos@AndrewLozovyi