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FDA Solicitation of Comments on Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion

What’s New/Significant

In a Jan. 28 Federal Register notice, the Food and Drug Administration (FDA) announced plans to study the impact of influencers and payment disclosures on the prescribing of drugs.


The FDA intends to build upon previous research by examining four types of endorsers (celebrity, physician, patient and influencer) in two separate studies, and evaluating whether the presence of a disclosure of their payment status influences participant reactions. The FDA also proposes to test two different types of disclosure language — one direct and more consumer friendly and one less direct.

Study A will include three types  of endorsers (celebrity, physician and patient) and two possibilities for payment disclosures (present or absent) within a print Direct-to-Consumer (DTC) ad for a fictitious acne product. Study participants will be randomly assigned to see one of the endorsers and view the ad either with or without a payment disclosure, such as “[Endorser] has been paid to appear in this ad for Drug X.”

Study B will include a patient and an internet influencer (defined as someone who provides online content to a number of followers) and will also manipulate the explicitness of the payment disclosure. The disclosure will be direct (e.g., “Paid ad …”), indirect (e.g., #sp for “sponsored”) or absent. The setting for this study will be an Instagram post for a fictitious endometriosis product. This study will partially replicate Study A and extend it by further tweaking the explicitness of payment as another manipulated variable, using a different set of endorser types and in a different promotional setting.

The purpose of the studies is to evaluate the role of endorsement and payment status on participants’ recall, benefit and risk perceptions, and behavioral intentions.

Next Steps

The FDA is soliciting comments on the proposed study, titled “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.”  Comments are due March 30.