FDA Will Study Impact of Influencers on Drug Market

Advertising Law

The Food and Drug Administration (FDA) has announced plans to consider the impact of influencers and payment disclosures on the prescription drug market with a pair of new studies.

In a Federal Register notice, the agency proposed to examine four types of endorsers (celebrity, physician, patient and influencer) in two separate studies, researching whether the presence of a disclosure of their payment status influences participant reactions. The FDA also plans to test two different types of disclosure language: one “direct and more consumer-friendly” and a second “less direct” form.

For purposes of the studies, the FDA defined an “influencer” as “a ‘regular’ person who has gained a following on a blog, a Twitter feed or other social media medium.”

The first study will manipulate three endorser types (celebrity, physician and patient) and payment disclosure—either present or absent—within a print ad for a fictitious acne product. The FDA intends to recruit 654 general population individuals who report familiarity with the celebrity (one who has spoken publicly about acne, although the agency declined to divulge his or her identity).

Participants will be randomly assigned to see one of the endorsers and to see the ad either with or without the payment disclosure, which will be similar to “[Endorser] has been paid to appear in this ad for Drug X.”

In the second study, the FDA will examine two endorser types, patient and Internet influencer, as well as “the explicitness of the payment disclosure” using a disclosure that is direct (such as “Paid ad”), indirect (including “#sp” for “sponsored”) or absent. The setting will be an Instagram post for a fictitious endometriosis product. A subset of 698 followers of an Internet influencer with an Instagram page featuring more than 500,000 followers and has posted about endometriosis will be recruited.

“In both studies, we are interested in the role of endorsement and payment status on participants’ recall, benefit and risk perceptions and behavioral intentions,” the agency explained, including “attention to disclosure statement and risk/benefit information; retention of risk/benefit information; recognition of piece as promotion and endorser as paid; perceived benefits and risks, attitudes toward the product, endorser and ad; and behavioral intentions such as asking a doctor about the drug.”

Comments on the proposed studies will be accepted until March 30.

To read the FDA’s study plans, click here.

Why it matters: The power of influencers to sell products to consumers is clear, and the FDA intends to get a handle on just how effective such endorsements are in the world of pharmaceuticals and the importance of payment disclosures. The agency has dealt with an influencer endorsement issue in recent years, sending a warning letter to the makers of Diclegis for influencer posts that included false and misleading content in violation of the Federal Food, Drug, and Cosmetic Act.