United States:
FDA Announces Information Collection On “Endorser Status And Explicitness Of Payment In Direct-To-Consumer Promotion”
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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.
This article is presented for informational purposes only
and is not intended to constitute legal advice.
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