April 18, 2022 – A recent enforcement letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Bausch Health Companies Inc. takes issue not only with omission of risk information in a direct-to-consumer (DTC) video and a webpage of a healthcare professional website, but also with a lack of balance between how risk and benefit information is treated in promotional materials.
In a March 31 Untitled Letter, OPDP states that the video and webpage “make false or misleading claims and/or representations regarding the risks associated with and the efficacy” of Duobrii™ Lotion, indicated for the topical treatment of plaque psoriasis in adults. This is the second time since February 2020 that Bausch has received an enforcement letter for Duobrii promotions.
In particular, OPDP points out that compliance with FDA promotional requirements is achieved by giving equal weight to risks and benefits, which includes using imagery and graphics that support that weighting.
OPDP notes that Bausch “fails to present information related to the warnings and precautions … with a prominence and readability reasonably comparable with the presentation of information related to the benefits.” For example, presenting risk information in text-only format in a small font – relegated to the bottom of the screen – and presenting benefit information prominently on the screen in a large font while also including audio discussing benefits, “undermines the communication of important risk information.”
In OPDP’s view, the video for Duobrii, which originally was featured on Lifetime TV’s The Balancing Act, includes efficacy claims but fails to highlight important risk information associated with the drug, including material facts about the embryofetal risk that are included in the “warnings and precautions” section of the drug’s prescribing information (PI). The Duobrii PI states that women who wish to use the drug should obtain a pregnancy test within two weeks prior to starting the therapy and should use effective contraception during treatment.
“This omission is especially concerning given that the patient, who appears to be of child-bearing age and is seen in the video with two young children,” makes a claim in the video which “suggests that a female of reproductive potential can initiate Duobrii or use it whenever she has a psoriasis flare up without regard to the measures needed to mitigate the risk of birth defects associated with Duobrii,” the enforcement letter states. Even though the video includes some information about this risk, OPDP states, “this does not mitigate the misleading impression.”
The video also omits a Duobrii PI warning about photosensitivity, risk for sunburn and a need for sunscreen or protective clothing, the OPDP letter states, and that omission “is further exacerbated by claims and presentations of a Duobrii-treated patient depicted outside, with exposed shoulders and arms.” Accordingly, OPDP states, the video “misleadingly suggests that Duobrii is safer than has been demonstrated.”
Additionally, the video includes misleading claims about the clinical superiority of Duobrii over other treatments “when this has not been demonstrated,” and about Duobrii’s effectiveness in patients who failed to respond to other plaque psoriasis treatments “when this is not the case.” OPDP does not dispute that the spokesperson’s experiences may accurately reflect these claims and acknowledges that superimposed text includes a disclaimer about individual results, but it states that the available clinical data “do not support the suggestions.”
The efficacy webpage of the HCP website for Duobrii also is problematic, according to OPDP. It “creates a misleading impression regarding the efficacy and mechanism of action of Duobrii because it draws conclusions based on data that are inadequate to support such conclusions.” The letter cites post hoc analyses of a single phase 2 trial which was not designed to support the conclusions drawn in the claims, OPDP states. Further, the presentation of data regarding this trial is misleading “because it overstates the efficacy of the drug.”
Although Bausch did include a statement on the webpage about the post hoc analysis, OPDP again stated that this statement “does not mitigate the misleading impressions created by these claims and presentations.”
The Untitled Letter sent to Bausch is the second Untitled Letter issued by OPDP in 2022. OPDP issued four Untitled Letters in 2021 and two Untitled Letters in 2020.