Feb. 3, 2020 – How much effect the status of drug product endorsers – be they celebrities, physicians, patients or social media influencers – has on consumers is the subject of a new study proposed by the FDA’s Office of Prescription Drug Promotion (OPDP) in the Jan. 28 Federal Register.

“We are interested in the role of endorsement and payment status on [study] participants’ recall, benefit and risk perceptions, and behavioral intentions,” OPDP stated in the notice. The agency proposes to extend previous research on the subject by examining the four types of endorsers and “whether the presence of a disclosure of their payment status influences participant reactions.”

“OPDP is studying an important issue here,” noted Jon Bigelow, executive director of the Coalition for Healthcare Communication. “Celebrity endorsers have been used in drug ads for years, but their increased use in social media has intensified questions about how endorsements, and the clarity of acknowledging payment, affects consumer perceptions.”

OPDP is proposing two concurrent studies:

• Study A will look at three types of endorsers – celebrity, physician and patient – and two levels of payment disclosure – present and absent – within a print direct-to-consumer (DTC) ad for a fictitious acne medication. OPDP notes that all 654 recruited subjects must report familiarity with the celebrity, and that the celebrity must have spoken out publicly about acne.
• Study B also will look at endorsers, but will focus on a patient and an Internet influencer. In this study, OPDP also will “manipulate the explicitness of the payment disclosure in addition to its presence, resulting in a two (endorser: influencer, patient) by three (payment disclosure: present-direct, present-indirect, absent) between-subjects design.” Study B will center on an Instagram post for a fictitious endometriosis product and will recruit 698 followers of an Instagram influencer with more than 500,000 followers who has posted about endometriosis.

In both studies, participants will view one promotional piece and answer questions online. Dependent variables in the studies will include:

• Attention to risk 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 (e.g., asking a doctor about the drug).