In today’s Federal Register, the agency has announced that the Office of Prescription Drug Promotion (OPDP) is adding a new study effort to its research portfolio. The category of that body of research that is currently underway includes a range of topics, including an assessment of terms and phrases commonly used in prescription drug promotion, studying the comprehension and understanding of multiple indications used in consumer television advertisements, and endorser status and explicitness of payment in Direct-to-Consumer promotion, among others.
In relation to the the last, today’s study announcement is also focused on the role of endorsements – “Endorser Status and Actual Use in Direct-to-Consumer Television Ads”. The notice published by FDA states that the aim of this effort is to complement the endorser status noted above, which apparently has been completed. That study had looked at endorser types in print or internet use to see how disclosure of payment status might impact audience reactions. The new research effort will look at actual-use disclosures in the medium of television advertising. The agency notes that prior research had indicated that the most influential endorsements to lead to purchase intentions were by physicians or pharmacists, followed by consumer endorsements and in last place, celebrity endorsements.
The agency notes that when healthcare providers are used in an endorsement, there should be a disclosure of compensation and that industry principles also recommend that there be disclosure when an actor is being used to portray a healthcare provider, though industry standards do not mentions such disclosure when a consumer/patient is represented by an actor. With the new research, FDA intends to examine the influence of patient/physician endorsements as well as ads where there is a utilizer of the product or an actor to assess attitudes and perceptions of the audience with respect to risk/benefit and behavioral intentions.
Why is this noteworthy?
Two things come to mind. First, direction of OPDP research may sometimes shed light on a developing area of interest in relation to enforcement. In other words, the data that they reap in these studies might inform a principle or perspective with respect to the use of endorsers that could have an influence on what they are looking at with respect to taking enforcement action. That seems a bit of a stretch in this regard, particularly in light of the fact that visible enforcement by OPDP has been close to non-existent. No enforcement letters have been issued during this calendar year, and in fact, the last action letter sent by OPDP was 10 months ago in June, 2022. This seems mostly like an academic exercise rather than anything with substantive impact – still, those who are utilizing endorsements in promotional communications should pay attention to both of these related studies for insights.
Second, it also tells us that even though the tide in communications on both the part of patients and promoters has shifted dramatically to the digital realm – often viewed on mobile devices – FDA’s attention remains focused on yesteryear and DTC advertising on broadcast television.
Presumably the first endorsement related study will be published soon. Keep an eye peeled for insights.