US regulators have sent pharmaceutical manufacturer Valeant Pharmaceuticals an untitled letter after finding a promotion for its Huntington's disease-treatment drug Xenazine omits "material facts," including risk information, while overstating the efficacy of the drug.
Valeant does not itself market the drug, which is marketed by Lundbeck, but does own the new drug application under which the product is marketed .
In its 20 June letter to Valeant, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) takes aim at a "patient assessment video" posted on the Medscape.com website in which a male patient is portrayed as experiencing what FDA referred to as "significant improvements" in his balance and ability to walk.
The agency called the portrayal as misleading because the product is not indicated for improving a Huntington's disease patient's balance, walking or postural stability. "In fact, the pivotal trial supporting the approval of Xenazine failed to demonstrate a statistically significant benefit for Xenazine in the Unified Huntington's Disease Rating Scale (UHDRS)Total Motor score, a domain of the UHDRS that assesses motor function and which includes the assessment of Total Chorea Score and 14 other items such as gait, tandem walking, and retropulsion pull test," explained FDA.
Omission of 'Material Facts'
Valeant was also cited by FDA for allegedly omitting "material facts" after the same patient video included a segment about the proper procedure for establishing an appropriate dose of Xenazine for each patient but neglected to include all factors necessary to establish a proper dose.
OPDP further chided Valeant for purportedly omitting and minimizing risk information for Xenazine. "The patient assessment video, which is 3 minutes and 55 seconds in duration, presents many claims regarding the efficacy of Xenazine but minimizes the risks of Xenazine by failing to convey any (emphasis original) risks associated with Xenazine during this audio-visual presentation," FDA wrote.
Though the risk information for the product is contained in text format elsewhere on the webpage, FDA explained it was "relegated" to a less prominent area of the webpage and "unlikely to draw the viewer's attention."
"The overall effect of the risk presentation undermines the communication of important risk information for Xenazine, thereby misleadingly suggesting that the drug is safer than has been demonstrated by substantial evidence or substantial clinical experience," FDA added. The agency also called attention to the omission of a series of other product risks it claims were minimized, including akathasia, restlessness, agitation, parkinsonism and dysphagia, as a result of not explaining the recommended response to each condition.
In a statement to Regulatory Focus, Valeant's Vice President for Investor Relations, Laurie Little, said the company had already taken steps to remedy FDA's allegations. "Valeant has discontinued use of all patient assessment videos in response to the Agency's 21 June 2012 letter," explained Little. "All future patient assessment videos will reflect the guidance provided therein.
Little also confirmed Valeant had responded to FDA's untitled letter, which had requested a response by 6 July in addition to the cessation of the dissemination of the allegedly violative marketing materials.
FDA's untitled letter to Valeant
Valeant's Marketing Piece