As the FDA steadily churns out a stream of untitled letters chastising pharmaceutical advertisers’ direct-to-consumer materials, a commercial for Bristol Myers Squibb’s Cobenfy is taking its turn in the hot seat.
The minute-long ad in question, dubbed “Bryan’s Story,” debuted in the fall and follows the titular patient skateboarding through an average day in his life, with voiceovers describing how Cobenfy can help manage schizophrenia symptoms.
The FDA’s Dec. 15 untitled letter (PDF) was publicly posted Thursday and takes issue with four aspects of the commercial.
For one, the agency disapproved of the ad’s voiceover and on-screen text claiming that Cobenfy use can result in improvements “across a range of schizophrenia symptoms,” both positive and negative.
The FDA noted that trials supporting Cobenfy’s approval didn’t assess improvements in positive and negative symptoms as separate groups, with its primary efficacy measure based on a scale combining a range of symptoms. It went on to add that the trials “were not designed to evaluate the efficacy of the drug in treating negative symptoms” as participants were experiencing acute exacerbations of schizophrenia, “which can confound the assessment of improvements in negative symptoms.”
“Therefore, making representations that treatment with Cobenfy improves negative symptoms in patients with schizophrenia is misleading,” the agency wrote.
The letter also singled out a line in which a voiceover says, “If you still have symptoms, be bold and ask your healthcare provider about Cobenfy,” which the FDA said suggests that Cobenfy is effective in people with treatment-refractory schizophrenia, a group that wasn’t specifically studied in the pivotal trials.
In its third point, the letter raised concerns about the ad’s description of Cobenfy as “not an antipsychotic” but “a different kind of treatment.” Though the drug boasts a different mechanism of action than traditional antipsychotics, it’s been widely billed as a new type of antipsychotic rather than a total departure from the category.
As the FDA wrote, “Cobenfy is considered a member of the antipsychotic drug class based on its therapeutic indication for treating schizophrenia and its effects on psychotic symptoms, not its mechanism of action.”
Finally, echoing its criticisms of other TV drug ads, the FDA claimed that the commercial’s “compelling, attention-grabbing visuals” distract from the major statement of the drug’s potential risks and side effects, further adding to the ad’s allegedly “misleading” nature.
The agency gave BMS 15 working days to address the cited concerns. BMS did not respond to Fierce Pharma Marketing’s request for comment.
The Cobenfy commercial is the latest in a long string of TV spots and other marketing materials to earn the FDA’s ire in the months since the Trump administration directed the agency to rein in DTC pharma advertising—an order that was quickly followed by a veritable flood of untitled and warning letters.
The flow has continued since then, albeit on a less massive scale. In the last month alone, for example, the regulator has posted missives to AstraZeneca, Daiichi Sankyo, SK Life Science and PharmaTher, some of them backdated to September.