Bausch Health pulls ‘untitled letter’ from OPDP for DTC video, HCP webpage

Bausch Health has drawn attention to a promotional video and webpage that regulators say mislabeled its prescription psoriasis cream Duobrii.

Bausch was targeted because the video and webpage downplay the risks associated with the drug and mislead about the overall benefit patients can expect, according to a untitled letter sent by the Office of Prescription Drug Promotion (OPDP) of the FDA.

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 Web page 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 January 2022 untitled letter for the social media promotion around Eli Lilly’s Trulicity diabetes injection, Bausch’s letter comments not only on the omission of risk information, but the way that information is presented.

“For a few years, we’ve seen OPDP letters focus on areas where risk information was completely omitted,” recalled Dale Cooke, attorney and regulatory consultant. “In this case and in the case of the letter from Trulicity, it was about the alleged de-emphasis of the risk information, as opposed to its omission.”

The video fails to mention some material facts, including a warning that Duobrii carries about the risks of birth defects. This is of particular concern, the agency wrote, because women of childbearing age must get a negative pregnancy test within two weeks of starting the product and use birth control. A patient featured in the video looks like Duobrii can be applied every time there is a flare, regardless of these measurements.

Although some information regarding the risk is presented in the video, it “does not mitigate the misleading impression,” the letter read.

Co-hosted by Montel Williams, the segment in question “appears to be a form of native advertising. It’s embedded in the content,” Cooke noted. It’s not as simple as in traditional audiovisual media.

Product placement is a mature promotional tactic. But so do regulators’ fair balance expectations — which Cooke says are well within requirements dating back at least to 2009, if not decades earlier.

“It’s something we see a lot more of,” he observed. “We see influencers coming forward. As marketers try to take advantage of different opportunities, OPDP is taking notice. »

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 talking indiscriminately. In the video, a medical spokesperson claims that Duobrii – a lotion containing the active ingredients halobetasol propionate and tazarotene – is the “first and only” topical combination indicated for the treatment of plaque psoriasis. This is not the case, points out the FDA.

With respect to the webpage copy, the claims of “demonstrated synergy” and “superior efficacy” over the aggregated results of two monotherapies are based on a comparison of Duobrii with its individual components. These data were derived from a post-hoc analysis of a single phase 2 trial, which was not designed to support this conclusion.

Merely noting that on the site is insufficient, says the OPDP, even for doctors. The site also shows a much greater difference in effectiveness between the treatment arms than has actually been demonstrated.

Bausch Health is required to submit a response to the OPDP within 15 business days.