Valeant Racks Up FDA Letters Criticizing Its Promotional Materials
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA says Valiant’s webpage for Zovirax overstates the efficacy of the herpes drug and makes unsubstantiated claims it is superior to Valtrex. It is the fifth letter the agency has sent the company in the past year.
Valeant Pharmaceuticals International Inc. may have set a record with FDA. In the past year the company has received five letters from the agency objecting to its promotional materials.
Most recently, FDA’s Office of Prescription Drug Promotion sent a “notice of violation” letter to Valeant Pharmaceuticals North America LLC regarding its webpage for the herpes drug Zovirax (acyclovir), which FDA says makes unsubstantiated superiority claims toGlaxoSmithKline PLC’s Valtrex (valacyclovir).
The webpage makes the claim that Zovirax is “Proven Effective At Any Stage, Even When Therapy Is Initiated Late.” A chart below this headline presents six progressive stages of an untreated herpes lesion with a checkmark indicating Zovirax treatment can begin at each stage. The chart compares Zovirax to Valtrex, stating that there is no data on the effectiveness of treatment with Valtrex at stages two to six.
“This presentation misleadingly overstates the efficacy of the drug by suggesting that Zovirax is proven effective when initiated during the ulcer or weeping, crust or scabbing, or healing stages (stages 4-6) of a herpes lesion, when this has not been demonstrated by substantial evidence or substantial clinical experience,” FDA stated in the July 18 letter.
In addition, FDA said the presentation “misleadingly implies that Zovirax is clinically superior to Valtrex due to an extended timeframe of treatment initiation.” However, the agency said it is “not aware of substantial evidence or substantial clinical experience to support the implication that Zovirax is superior to Valtrex, regardless of when treatment is begun.”
FDA Previously Cited Company For A Website And Web Video
The agency also said the references cited in the promotional piece do not support its claims. For example, one reference is a review article that discusses herpes simplex viral infections and various treatment options, which FDA said does not constitute substantial evidence to support claims of efficacy at any stage.
Valeant said it has made appropriate changes to the website and responded to FDA. As for the recent spate of letters, a spokesperson said the company responds quickly to correct any issues when they are brought to its attention.
“It is not something we want to see,” the spokesperson said. “We are undertaking several reviews.”
The Zovirax letter was issued one month after FDA sent a “notice of violation” letter to Valeant objecting to its web video for Xenazine (tetrabenazine). The agency said the testimonials in the video from patients with Huntington’s disease implied greater efficacy for the drug than is supported by the evidence and omitted or minimized risk information (Also see "Walk Back Those Walking Claims, FDA Tells Acorda And Valeant" - Pink Sheet, 6 Jul, 2012.).
In March, OPDP sent a “notice of violation” letter to Valeant subsidiary Dow Pharmaceutical Sciences Inc. criticizing a website and detail aid for the acne treatment Atralin Gel (tretinoin) (Also see "Atralin Acne Gel Awarded “A+” In Valeant Ad, But FDA Sends Promo To Back Of The Class" - Pink Sheet, 22 Mar, 2012.). Dow also received a letter in June 2011 for claims in its website for the acne treatment Acanya Gel (clindamycin phosphate and benzoyl peroxide) (Also see "Drug Ads Should Take A Long View, DDMAC Says In Citing Time-To-Onset Claims" - Pink Sheet, 6 Jul, 2011.).
And in August 2011, Valeant’s Aton Pharma division was cited by FDA for problems with a slide presentation for its oral vitamin K1 product Mephyton (phytonadione) (Also see "Listing Indication Does Not Absolve Aton From Off-Label Examples In Mephyton Slides, FDA Says" - Pink Sheet, 26 Aug, 2011.).