On March 31, 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Bausch Health over misleading statements the company made on Montel Williams’ morning show, “The Balancing Act,” about Duobrii, a lotion for the treatment of plaque psoriasis.
In its letter, OPDP noted that it had reviewed the promotional materials – including a direct-to-consumer video and corresponding storyboard – and the company website and found that the materials were not in compliance. OPDP also noted that it had previously expressed similar concerns in February 2020, where Bausch seemed to be promoting Duobrii “without presenting the serious risks and efficacy of the drug in a truthful and non-misleading manner.”
FDA listed a number of omissions and overstatements in the promotional video and website that can either alert patients to certain risks associated with the lotion, or make it seem like it is the only option for patients suffering from psoriatic plaque.
OPDP stated that the video was “originally featured on Lifetime TV’s The Balancing Act. The video and webpage make false or misleading claims and/or representations regarding the risks associated with and the efficacy of Duobrii” and that the “violations are concerning from a public health perspective because the video fails to include information regarding serious risks associated with Duobrii, a topical product that bears warnings and precautions related to serious systemic risks and serious skin reactions. In addition, the video and webpage create a misleading impression regarding the overall benefit a patient may expect as a result of Duobrii treatment.”
FDA takes issue with the fact that the video highlights a patient who is of child-bearing age, shown with two young children, claiming benefits from using the lotion. However, OPDP notes that if a pregnant woman were to use the product, it could put a fetus at risk. The PI specifically states that patients should “obtain a pregnancy test within 2 weeks prior to DUOBRII Lotion therapy,” and that it’s important to “advise females of reproductive potential to use effective contraception during treatment with DUOBRII Lotion therapy.” Therefore, the agency is concerned that the video could potentially mislead women to think they can use the lotion when pregnant, without any risk.
“We acknowledge that some information regarding embryofetal risk is presented in the video; however, this does not mitigate the misleading impression created by the omission of material facts regarding the need for pregnancy testing and birth control from the video,” FDA states.
FDA also noted that the video included testimonial from another patient – outside, with exposed shoulders and arms – who said she was now able to wear more revealing clothing because her psoriatic flare-ups had been reduced. However, the video did not include any information about taking precautions for photosensitivity and risk of sunburn, despite the warning label clearly stating that patients need to continue use of sunscreen and wear protective clothing to protect themselves from sunburn.
“By omitting serious risks associated with Duobrii and material facts pertaining to serious risks, the video misleadingly suggests that Duobrii is safer than has been demonstrated,” the agency said.
This untitled letter is the third of 2022, following a February warning letter to CytoDyn over promotional statements made by its former CEO about an investigational drug and a January untitled letter sent to Eli Lilly over a social media post for Trulicity.