FDA: Bausch Health’s Duobrii promotions misleading

The FDA has charged Bausch Health with making false or misleading claims about its topical plaque psoriasis cream Duobrii.

A fixed combination of tazarotene and halobetasol propionate lotion, Duobrii was approved by the FDA to treat plaque psoriasis in 2019.

In a March 31, 2022, letter to the company, the FDA’s Office of Prescription Drug Promotion (OPDP) called out a video, which aired on network television, for failing to include information regarding potential embryofetal risk or the risk of photosensitivity or 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 letter states.

Additionally, the video claims Duobrii is the first and only topical drug to combine two active ingredients with anti-inflammatory properties, which is not accurate, and makes claims about superior and fast efficacy that have not been proven to be true, the letter continues.

“Together, these claims are misleading because they suggest that Duobrii is clinically superior to or more effective than other treatments for plaque psoriasis when this has not been demonstrated,” the letter reads.

Promotional materials present on the company’s website were also called into question for creating a “misleading impression regarding the efficacy and mechanism of action of Duobrii.”

The ODPD requests the company submit a written response within 15 working days addressing the issues and stops using promotional materials that violate the FD&C Act.

Since receiving the letter, Bausch Health has been in touch with the FDA and is working to respond in the requested timeframe, a company spokesperson told Healio.