In 2015, Kim Kardashian ran afoul of FDA's drug marketing rules and put a spotlight on the role so-called social media influencers play in consumers' prescription drug buying habits—and nearly five years later, FDA is launching new studies to examine influencers' impact.

The rise of social media influencers

Social media influencers—people who are paid to endorse products to their hundreds of thousands of followers—have been around for several years.

But Kim Kardashian stirred up controversy in the health care industry in 2015 when FDA sent her a warning letter over her paid promotion of a morning-sickness treatment on her social media accounts. According to STAT+'s "Pharmalot," Kardashian's promotion boosted sales of the drug by 21% in a few months' time, and FDA was concerned that Kardashian's social media post, which was sponsored by the drugmaker, hadn't disclosed any of the risks associated with the medication.

Since then, drugmakers and other companies increasingly have teamed up with celebrities, doctors, and other prominent industry professionals who boast large social networks to tout the companies' products on Instagram, Twitter, and other social media platforms. Some companies even are turning to "micro-influencers," who usually are patients with a smaller online following, to promote their products.

Both methods have resulted in big returns for drug companies, and FDA has taken notice. The agency now is launching a new initiative to study the influencers' impact.

FDA to launch studies focused on measuring influencers' impact

While previous research examined how different types of social media influencers impacted purchase intentions, FDA's Office of Prescription Drug Promotion (OPDP) will explore how direct-to-consumer (DTC) advertisements featuring product endorsers affect consumer's perceptions of prescription drugs, and whether disclosing the payment impacts consumer reactions. FDA's studies will focus on four different types of product endorsers: celebrities, social media influencers, patients, and physicians.

FDA said it is particularly interested in the role celebrity endorsements can play in consumers' "benefit and risk perceptions, and behavioral intentions," including whether or not a consumer is prompted to speak with a doctor about the product featured in the advertisements.

The agency plans to launch two studies for the research. For one study, FDA will recruit 654 participants who will be randomly assigned to look at print direct-to-consumer ads for a fake acne medication that includes endorsements from a celebrity who has spoken publicly about acne, a physician, and a patient. Some of the ads will include either direct or indirect disclosure language, and some won't include any disclosure language. FDA will gauge participants' reactions to the ads.

For the second study, FDA plans to recruit about 700 people who follow an internet influencer who has disclosed having endometriosis and has more than 500,000 followers on Instagram. FDA will then show participants Instagram posts for a fake endometriosis product touted by the influencer and a patient. FDA will look to determine how endorser type affected participants' perceptions and behavior toward the product.

Expert says FDA's research will bring a 'refreshing focus' to studies on pharma ads

Mark Senak, a senior VP at the FleishmanHillard public relations firm, said FDA's new research is necessary. "The bulk of research efforts in my observation are still predominated by" typical DTC ads, Senak said. "So the fact that [FDA is] looking at Instagram is a refreshing focus." 

Former Eli Lilly executive Richard Meyer said the studies' results could prompt FDA to change regulations on pharmaceutical advertisements. "If the result is that one type of endorsement is more pertinent than others, it signals an area that the FDA … will look at more closely in future enforcement actions," he said. "So if experts are the most influential, it will be those social media assets that the agency looks to for enforcement moving forward" (Wang, Inside Health Policy, 1/28 [subscription required]; Brennan, Regulatory Focus, 1/27; Silverman, "Pharmalot," STAT+, 1/28 [subscription required]).