The FDA is not feeling the love in a commercial for Novartis’ paroxysmal nocturnal hemoglobinuria (PNH) treatment Fabhalta.
In an untitled letter (PDF) sent to the Swiss pharma last week, the regulator’s Office of Prescription Drug Promotion (OPDP) chastised the TV ad for being distracting to the point of “misleading.”
The 90-second commercial, which can be viewed on the Fabhalta website, introduces a PNH patient named Lewis and several of his unique quirks, which include a love of tie-dyed clothing and a habit of eating pizza crust-first—a concept that the ad uses to showcase how Fabhalta can fit into a variety of individual lifestyles.
The FDA’s letter took issue with several aspects of the ad. For one, it criticized the 25-second segment in which a voiceover reads off the requisite “major statement” of the most important risks and side effects of Fabhalta, all while Lewis is shown having a meet-cute with a woman in the produce section of a grocery store and a bit later, in a conclusion fit for a rom-com, dancing at a wedding with her as his date.
That “romantic story arc” contributes to a misleading impression, according to the agency, “because this compelling and attention-grabbing presentation, combined with multiple scene changes and background music during the presentation of the major statement, interferes with comprehension of the major statement.”
The FDA also dissected an earlier 9-second segment in which the voiceover says “the best part” of Fabhalta is that it’s “a twice-daily pill that substantially improved hemoglobin levels compared to [AstraZeneca’s] Soliris or Ultomiris infusions,” while smaller onscreen text, known as a “super,” provides study data to support that claim.
The regulator complained not only about the short amount of time given to read the 65-word super, but also the upbeat background music and additional onscreen text that may pull focus from the clinical information.
“The presentation of the SUPER is undermined by multiple, competing presentational aspects that distract the viewer from material information about the benefits of Fabhalta and, therefore, creates a misleading impression about the drug’s efficacy,” the OPDP wrote.
The agency has requested that Novartis “take immediate action” to address the complaints and gave the company 15 working days to respond to the letter with either its plans for doing so or its reasoning as to why the ad isn’t a violation of the FDA’s rules.
Novartis did not immediately respond to Fierce Pharma Marketing’s request for comment.
The Sept. 23 untitled letter follows a massive wave of similar scoldings that the FDA issued earlier this month, as President Donald Trump and the FDA pledged to crack down on what they perceive to be “misleading” or “deceptive” direct-to-consumer pharmaceutical ads.
The dozens of untitled letters and warning letters that followed were all dated Sept. 9, the same day the administration unveiled the crackdown plans, and signed by either George Tidmarsh, M.D., Ph.D., director of the FDA’s Center for Drug Evaluation and Research, or Vinay Prasad, M.D., director of the Center for Biologics Evaluation and Research.
The new Novartis letter, meanwhile, was signed by a pair of leaders from the OPDP—the typical source of such letters.