The United States Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently announced that it is working on two studies: one that will focus on Instagram influencers and how people perceive what they say and another one that will help understand how television viewers comprehend treatment indications and endpoints.
Instagram Influencers
The OPDP recognizes that many celebrities and models on Instagram post photographs with medicines, which is sometimes tagged as an ad. This “newer wave” of advertising has already had impacts on a variety of industries, including the prescription drug industry.
For those who don’t remember, back in 2015, Kim Kardashian received a warning letter from the FDA for promoting Diclegis (a morning sickness drug) without disclosing that it was a paid advertisement and without including proper risk information.
In this study, the FDA plans to manipulate the explicitness of the paid advertisement disclosure (i.e., direct – “paid ad,” indirect – #sp for “sponsored,” or absent altogether) and recruit 698 followers of an internet influencer with more than 500,000 followers and who has posted about endometriosis. While the influencer’s identity is not being revealed at this time to protect the integrity of the study, there are a few celebrities who may be the target: Alexa Chung, Padma Lakshmi, and Halsey. All three have more than 500,000 followers and have been open about their endometriosis on Instagram.
The study will look at an Instagram post made for a fictitious endometriosis product and gauge perceived benefits and risks of the product; attitudes toward the product; attitudes toward the endorser and the ad; and behavioral intentions, such as asking a doctor about the product. Another study in this vein (albeit a little less “techy”) will look at a print direct-to-consumer ad for a fictitious acne product and investigate the effects of the endorser (whether it is a celebrity, physician, or patient) and the payment disclosure (direct, indirect, or absent). For that study, the FDA will recruit 654 individuals who report familiarity with the celebrity (who will have publicly spoken out about acne). Stock photos will be used to depict a physician and patient, and participants will randomly be assigned to see one of the endorsers and the ad either with or without a payment disclosure.
Television Viewers
The OPDP is also planning to research how television viewers comprehend treatment indications and endpoints for cancer drugs.
One study will help OPDP determine whether disclosing information about the endpoints supporting a cancer drug’s indication(s) can actually help consumers better understand the efficacy of the drug. In this study, OPDP will create two different television ads for fictitious cancer drugs – one for non-small cell lung cancer and another for multiple myeloma. The ads will include audio claims about overall survival, overall response rate with and without disclosure, or progression-free survival with and without disclosure.
According to the Federal Register Notice filed by OPDP, participants will be randomly assigned to view one of the two ads and then complete a questionnaire that finds whether the participant noticed the disclosure, their retention of the endpoint, and what their perceptions are as to the drug’s benefits and risks.
The second study will test whether consumers can adequately understand and comprehend indication statements when portions of the indication are presented only in the superimposed text of the ads, in the audio of the ad only, in both the superimposed text and audio, or in neither the superimposed text or audio.
According to OPDP, “Following previous research on dual-modality presentations, we hypothesize that participants who view an ad with the material information in the audio and text will have greater retention of that information than participants in any other condition. We also hypothesize that participants who view an ad with the material information in the audio only will have greater retention of that information than participants in the superimposed text condition and the control condition.”