The FDA’s drug ad policing body has called out Bausch Health for failing to show all the risks of its psoriasis cream, Duobrii.
In an untitled letter dated March 31, the FDA’s Office of Prescription Drug Promotion (OPDP) said Bausch Health ran a video during Montel Williams’ Lifetime morning show "The Balancing Act" that made “false or misleading claims and/or representations regarding the risks associated with and the efficacy of Duobrii.”
The video appears to have since been removed from online services including YouTube. Bausch was given 15 days to reply and address the concerns. The company did not respond to a request for comment from Fierce Pharma Marketing.
The FDA found the video failed to show several safety risks associated with the drug that includes risks for the babies of pregnant women. In the video, a woman “of child-bearing age,” as the OPDP notes, and with children alongside her, says she can use the drug whenever she wants.
This, the OPDP says, is misleading, as it suggests women can use Duobrii at any time, but if they were pregnant, this could pose a safety risk, which the video fails to fully show. The skin cream received FDA approval in 2019.
“We acknowledge that some information regarding embryofetal risk is presented in the video,” the OPDP said. “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.”
It also did not adequately show the need to take extra precautions for those with photosensitivity and the risk for sunburn.
There is a warning label on Duobrii which makes clear that patients need to use sunscreen and protective clothing to protect themselves from sunburns, but in the video the patient is seen wearing clothes out in the sun that aren’t as protective, given that her plaque psoriasis is not showing up.
“These claims and presentations misleadingly suggest that a patient does not need to take measures to avoid exposure to sunlight after treatment with Duobrii, when this is not the case,” the OPDP ruled.
And there's more. Bausch is also accused of “misleadingly implying” that Duobrii has been shown to be effective in patients who failed to respond to other plaque psoriasis treatments, “when this is not the case,” the FDA office said.
This came when the patient depicted in the ad says: “I have seen many doctors over the last 11 years for my psoriasis. The creams I was prescribed were thick and greasy, and they had an odor, and they did not work for me.”
This is only the second untitled letter to be sent out from the OPDP this year. The first came in January under its Bad Ad program about a social media post for Eli Lilly’s diabetes medicine Trulicity that gave a “misleading impression about the scope” of its FDA label, according to the OPDP.