Is It News? Is It Promotion? OPDP’s Latest Letter Shines a Light on Native Advertising

A few weeks back, OPDP issued its second Untitled Letter of 2022 (third letter in 2022 overall) to Bausch Healthcare alleging violative DTC and HCP promotional communications for Duobrii (halobetasol priopionate and tazarotene) lotion.  Of interest (to me) is the DTC communication cited where OPDP, again, focuses on a video and alleges false or misleading representations regarding risks and efficacy.  This, however, is not just any video.  This was a segment from Lifetime Television’s “The Balancing Act” and signals FDA’s continuing interest in native advertising.

Although overall enforcement against prescription drug ads has been relatively low, the OPDP Warning and Untitled Letters issued over the past year reflect OPDP’s interest in not only the substance of the communications, but in the audience processing of information based on the platform used.  We discussed this with regard to OPDP’s recent Untitled Letter to Eli Lilly that raised issues with adequate communication of information (despite the fact that the relevant information was included within the ad).  And we’ve previously seen FDA take issue with content appearing as news (see Warning Letters to CytoDyn, and Cooper Surgical).

In a recent CDER Conversation with Kit Aikin, senior social science analyst and research team lead in OPDP, Dr. Aikin discusses OPDP’s social science research program and a November 2021 workshop with Duke Margolis that identified growing trends in advertising including social media influencers (“people with credibility in a specific industry, access to a large audience, and the power of persuasion”) and native advertising (“advertising embedded in a media source, so that consumers don’t necessarily know it’s advertising”).   The slide deck posted on Duke’s page includes a presentation entitled “DTC Rx Promotion in the Digital Space:  Native Advertising, TikTok & Gen Z as a Vulnerable Audience”  and highlights a prescription drug case study of advertising done in conjunction with the Dr. Phil show.  While OPDP’s research agenda does not specifically call out native advertising, there has long been an interest in consumer perceptions of DTC TV advertising, and OPDP in-progress research is evaluating endorsers and whether disclosure of payment influences participant reactions.

Although not a topic taken on directly by FDA,  native advertising has been overtly addressed by FTC, and sponsorship identification has been an ongoing FCC issue.  Outside of regulators (and, if I do say so, in a much more entertaining way), John Oliver has taken on the spon-con topic several times, including a 2021 episode highlighting issues with local news spon-con and “dicey medical claims.” (During the episode, Oliver provides examples of medical devices featured as part of spon-con on local news stations, and demonstrates how his team was able to buy local news time to promote “the world’s first sexual health blanket.”)

With regard to OPDP’s most recent letter, we note that Lifetime Television’s “The Balancing Act” is no stranger to FDA.  A Brandstar Original, the show leverages its platform to deliver branded “storytelling” content to its Lifetime TV audience.  Companies and their brands pay for segments and may further disseminate the segments through product/corporate websites and through social media platforms.  In the case of prescription drug segments (and in the case of the Duobrii segment), companies typically submit storyboards and scripts to FDA on Form 2253.  FDA has issued Untitled Letters for segments on the Balancing Act ranging from a flu vaccine, to a treatment for iron deficiency anemia, as well as one for multiple sclerosis.

In this most recent letter, the video segment tells the story of Katie, a plaque psoriasis patient and mother of 2 children.  Katie describes getting psoriasis when pregnant with her first child and, over the years, using creams on her psoriasis that did not work.   Katie discusses using Duobrii when she has a flare up and seeing results within days.

OPDP cited Bausch for misleading risk presentations as well as misleading efficacy.  Duobrii is indicated for the topical treatment of plaque psoriasis in adults and is contraindicated in pregnancy.  The Duobrii prescribing information carries warnings and precautions regarding embryofetal risk, hypothalamic-pituitary-adrenal axis suppression and other unwanted systemic glucocorticoid effects, photosensitivity and risk for sunburn.

OPDP expressed concerns that the video fails to include material facts regarding the warning and precaution for embryofetal risk, including the suggestion that “a female of reproductive potential can initiate Duobrii or use it whenever she has a psoriasis flare up without regard to the measures needed to mitigate the risk of birth defects associated with Duobrii . . .”  OPDP also expressed concerns about representations that the patient would not need to wear three quarter length sleeves when it was warm out because of the warning to use sunscreen and protective clothing when using Duobrii.  Bausch was cited for presenting information in text-only format while benefit claims were presented on screen in large print and announced verbally.  This citation is not new – we have seen it in several recent letters and is specifically addressed as part of 21 C.F.R. §202.1(e)(1) which provides that broadcast advertisements include information relating to the major side effects in the audio or audio and visual parts of the presentation.

On the efficacy side, OPDP cited Bausch for suggesting Duobrii is superior to other products intended for plaque psoriasis.  Of interest (again, to me) was OPDP’s recognition that the spokesperson’s own experiences may be TRUE, but are otherwise misleading because, “the personal experience of this patient does not support the suggestion that Duobrii is superior to other plaque psoriasis drugs on the market.”  With regard to disclaimers, OPDP states, “We acknowledge that the video includes the SUPER, ‘People with psoriasis may respond to treatments differently and at different times. Individual results may vary.’ However, this does not mitigate the misleading impression.”

While only time will tell, given the success of “The Balancing Act,” the sponsorship opportunities on both national and local TV show levels, as well as the rise in the use of social media influencers, it’s safe to say that these “storytelling” forms of promotion for medical products will not be going away anytime soon.  When appropriately utilized, that’s not a bad thing – elevating awareness of disease states and potential treatments helps improve patient understanding and may ultimately impact access.  Sponsors should responsibly communicate medical product information and be mindful that given FDA’s recognition of these promotional trends, we will likely see additional enforcement in these areas as well.