Posted: 18 Dec 2016 05:58 PM PST
By Jeffrey N. Wasserstein & Dara Katcher Levy –
Your friendly neighborhood bloggers were tempted to headline this post with a Buzzfeed worthy headline such as “When FDA pointed out THIS ONE THING, industry was SHOCKED!” or “FDA issues flood of letters – 25% of 2016 output in a single day. What happened next will leave you breathless!” But we restrained ourselves for we are models of decorum, substance, and gravitas. No, really.
On December 12, 2016, demonstrating that they’re not dead yet, the Office of Prescription Drug Promotion (OPDP) issued two letters relating to television ads, one to Sanofi-aventis relating to TOUJEO (insulin glargine injection) U-300, for subcutaneous use (here), and one to Celgene for OTEZLA (apremilast) tablets, for oral use (here). TOUJEO is indicated to improve glycemic control in adults with diabetes mellitus and OTEZLA is approved for the treatment of adult patients with active psoriatic arthritis and for patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Both drugs carry serious contraindications and risks.
OPDP had similar objections to both of the advertisements, namely that the presentation of risk information was false or misleading. Why was it false or misleading? Did the companies lie about the risks? Was the presentation of the risk information inadequate?
In a word, no. FDA had no objections to the substance of the risk communication. Rather, FDA objected to the presentation of the risk information. Specifically, FDA objected to the fact that the visuals changed fairly quickly and the background music was distracting.
The presentation of these compelling and attention-grabbing visuals and SUPERs, all of which are unrelated to the risk message, in addition to the frequent scene changes and the other competing modalities such as the musical interjections, compete for the consumers’ attention. As a result, it is difficult for consumers to adequately process and comprehend the risk information.In other words, playing Katrina and the Waves (OTEZLA), or Earth, Wind & Fire (TOUJEO) while rapidly shifting between distracting images can render otherwise appropriate risk information inappropriate and misbranding in nature. While your bloggers, as children of the ‘80s, applaud the musical choices, the takeaway from these letters is that OPDP still has what to say, and that in crafting the type of slick DTC ads we’ve grown to know and love, one must be careful to keep the viewer’s attention focused on the risk information when presenting such information, rather than distracting them with music and images that are unrelated to the presentation of risk information. Perhaps Men Without Hats’ “Safety Dance” would be more appropriate music?
lunes, 19 de diciembre de 2016
FDA Law Blog - Not Dead Yet – OPDP Issues Two Untitled Letters Late in the Year (Our 3,000th Post!)
FDA Law Blog: Not Dead Yet – OPDP Issues Two Untitled Letters Late in the Year (Our 3,000th Post!)