FDA Policy/General

Additional FDA ‘Native Advertising’ Enforcement Likely: Attorney

Attorney Dara Levy (Hyman, Phelps & McNamara) says additional FDA enforcement over the increasing sponsor use of so-called native advertising is likely. (Native advertising can be defined as the use of paid ads that match the look, feel, and function of the media format in which they appear.)

Writing in her firm’s FDA Law Blog, Levy discusses a CDER Office of Prescription Drug Promotion (OPDP) untitled letter issued to Bausch Healthcare about a video segment on Lifetime Television’s show “The Balancing Act,” promoting the company’s Duobril (halobetasol propionate and tazarotene) lotion indicated to treat plaque psoriasis.

OPDP cited Bausch for misleading risk presentation and misleading efficacy, Levy writes. One of the issues OPDP raised, she says, is a Bausch claim that Duobril is superior to other plaque psoriasis products. The untitled letter said the personal experience of a patient appearing in the show does not support the suggestion that Duobril is superior to other plaque psoriasis drugs on the market.”

“While only time will tell,” Levy concludes, “given the success of ‘The Balancing Act,’ the sponsorship opportunities in both national and local TV shows, 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.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome