FDA announces information collection on “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion”

On January 28, 2020, the Food and Drug Administration (FDA) announced that the Office of Prescription Drug Promotion (OPDP) will conduct two studies to examine how payment disclosure statements and the types of endorsers in drug advertisements affect consumers’ understanding of the information provided in the advertisements. Below is a summary of the studies. FDA invites comments on (1) whether studies like these are necessary for FDA to perform its duties, (2) the accuracy of the regulatory burden that FDA estimated, (3) how FDA’s information collection can be enhanced or improved, and (4) how the regulatory burden can be minimized through information technology.

The first study, involving a fictitious acne product, will recruit a total of 654 subjects (for the pretest and the main study) and will involve three different endorser types (celebrity, physician, and patient) and the presence of disclosure statements (for example, “[Endorser] has been paid to appear in this ad for Drug X”). The second study, for a fictitious endometriosis product, will involve 698 subjects (for the pretest and the main study) and will test the subjects’ reactions to endorsements by a social media network influencer and by a patient. This study would examine also how the different levels of explicitness in payment disclosure statements (for example, “paid advertisement” versus “#sp” for “sponsored”) used in the advertisements affect the subjects’ understanding of the content. FDA did not disclose the identity of the celebrity or the influencer who will be used in the trials.

Through these studies, FDA seeks to study information such as the audience’s retention of the presented risk/benefit information, recognition of the advertisement as promotion, and recognition of the endorser’s paid status, as well as behavioral intentions (for instance, asking a physician about the drug). The agency believes that these study will provide specific scientific evidence to assist in determining the agency’s policies regarding drug promotion. FDA will accept comments until March 30, 2020, and the authors would be pleased to discuss potential comments with those interested in submitting.