FDA knocks Bausch for misleading promotion of psoriasis drug on Lifetime show

Regulatory NewsRegulatory News | 12 April 2022 |  By 

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent Bausch Health an untitled letter for making misleading statements about its plaque psoriasis lotion Doubrii (halobetasol propionate and tazarotene) on Montel Williams’ Lifetime morning show “The Balancing Act.” The agency said the company exaggerated claims and failed to adequately inform people about the product’s risks.
In the untitled letter, dated 31 March, OPDP said it reviewed the company’s promotional materials, a direct-to-consumer video and corresponding storyboard, and Bausch’s website, and concluded the company’s promotional materials were not in compliance. The video cited in the untitled letter appears to have been removed from The Balancing Act website and YouTube at the time of writing.
The untitled letter is only the third enforcement letter OPDP has sent so far in 2022. The office sent a warning letter to CytoDyn in February over promotional statements made by its former CEO about an investigational drug and an untitled to Eli Lilly over a social media post for its type 2 diabetes mellitus drug Trulicity (dulaglutide). (RELATED: OPDP’s first warning letter of 2022 targets CytoDyn for COVID claims, Regulatory Focus 22 February 2022; Trulicity Instagram post draws OPDP’s first untitled letter of 2022, Regulatory Focus 24 January 2022)
“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,” FDA said. “These 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.”
More specifically, FDA notes that in the video a patient who is of child-bearing age and is shown with children claims benefits from using the lotion. However, Doubrii could put a fetus at risk if a pregnant woman uses the product. The agency is concerned that the video could 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 added.
Additionally, FDA said the video fails to include any information about taking precautions for photosensitivity and risk for sunburn. It notes that in the video another patient says she is now able to wear more revealing clothes because she’s not afraid of her psoriatic flare-ups from showing. However, the warning label on Doubrii clearly states patients need to use sunscreen and protective clothing to protect themselves from sunburns.
“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.
The untitled letter goes on to list a number of other omissions and exaggerations in its promotional video and web site that FDA said either fails to clearly alert patients to risks associated with the lotion or make it seem like it is the only option for those with psoriatic plaque.
FDA has given Bausch 15 days to respond to the untitled letter with either arguments why it thinks it is not in violation of misleading advertising and failing to alert patients about risks associated with Doubrii or plans to correct the concerns raised by the agency.


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