Bausch Health has drawn scrutiny for a promotional video and web page that, regulators said, misbranded its prescription psoriasis cream Duobrii.
Bausch was targeted because the video and web page downplay the risks associated with the drug and mislead regarding the overall benefit patients may expect, according to an untitled letter sent by the FDA’s Office of Prescription Drug Promotion (OPDP).
The direct-to-consumer video aired on Lifetime TV’s The Balancing Act (the show has since removed the video from its YouTube channel and consumer page). The webpage is on a site intended for doctors.
Untitled letters, a less severe form of enforcement than warning letters, notify the manufacturer of a regulatory violation. The letter to Bausch Health is the second of its kind in 2022, following four in 2021.
Like the January 2022 untitled letter for social media promotion around Eli Lilly’s Trulicity diabetes injection, the Bausch letter comments not simply on the omission of risk information but the manner in which that information is being presented.
“For a few years, we saw OPDP’s letters focus on areas where the risk information was completely omitted,” recalled Dale Cooke, an attorney and regulatory consultant. “In both this case and in case of the Trulicity letter, it was about the alleged de-emphasis on the risk information, as opposed to its omission.”
The video fails to mention some material facts, including a warning Duobrii carries about risks for birth defects. This is particularly concerning, the agency wrote, because women of child-bearing age need to obtain a negative pregnancy test within two weeks of starting on the product as well as use birth control. A female patient featured in the video gives the impression that Duobrii can be applied any time there is a flare-up, without regard to these measures.
While some information regarding the risk is presented in the video, it “does not mitigate the misleading impression,” the letter reads.
Co-hosted by Montel Williams, the segment in question “appears to be a form of native advertising. It’s blended in with the content,” Cooke noted. He added that presentation of risk information in these kinds of paid promotions is not as straightforward as it is in traditional broadcast media.
Product placement is a mature promotional tactic. But so are regulators’ expectations for fair balance – which, Cooke said, are very much in line with requirements dating back at least to 2009, if not decades before that.
“It’s something we’re seeing much more of,” he observed. “We’re seeing influencers come to the fore. As marketers try to make use of different opportunities, OPDP is taking note.”
The same format was flagged for a violation last year in a warning letter to CooperSurgical for Paragard, an intrauterine contraceptive.
Patients aren’t the only ones speaking out of turn. In the video, a physician spokesperson claims that Duobrii – a lotion containing the active ingredients halobetasol propionate and tazarotene – is the “first and only” topical combination med indicated for treating plaque psoriasis. That’s not the case, the FDA points out.
As for the web page copy, claims of “demonstrated synergy” and “superior efficacy” versus the aggregated results of two monotherapies are based on a comparison of Duobrii to its individual components. Those data were derived from a post-hoc analysis of a single phase 2 trial, which was not designed to support that conclusion.
Simply noting that on the site is insufficient, OPDP explains, even for physicians. The site also presents a much larger difference in efficacy between treatment arms than was actually demonstrated.
Bausch Health is required to submit a response to OPDP within 15 working days.