The Food and Drug Administration issued a warning to a pharmaceutical company regarding a Web site promotion for a pediatric atopic dermatitis treatment brought to its attention by a whistleblower as a result of the agency's "Bad Ad" program.
The agency sent a warning letter to Hill Dermaceuticals on Dec. 3. In the letter, the FDA said that the company's Web site promotion of its Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, 0.01% for pediatric atopic dermatitis are false and misleading "because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product."
The Web site was submitted to the FDA's Division of Drug Marketing, Advertising and Communications as a complaint in response to its "Bad Ad" program.
In May, the FDA launched the program, saying that it was encouraging physicians to bring misleading marketing to its attention.
The FDA's warning to Hill was posted on its Web site on Dec. 14. According to "The Pink Sheet," the agency said this was the first action taken as a result of the "Bad Ad" program.
In the letter, the agency noted that, according to Derma-Smoothe Body Oil's FDA-approved labeling, it is "indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established."
The Web site also made safety claims that seemed to ignore the host of warnings and precautions – in particular surrounding the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression – that are in the approved labeling, according to the FDA.
The agency went on to puncture many of the safety and marketing claims, stating that Hill had not provided supporting evidence. The company also seemed to broaden the indication with its suggestions on the site that the drug could be used in children of any age, and that Derma-Smoothe could be used on any area of the body.
"By omitting Derma-Smoothe Body Oil’s full indication, along with its important limiting information, you misleadingly broaden the indication and minimize the risks of the drug product," the agency wrote.
"What is even more concerning is that one of the webpages contains an image of a baby holding a circular sign in which 'Safety Concerns' is crossed-out. This image creates the misleading impression that there are no safety concerns with Derma-Smoothe Body Oil, when this is not the case," noted the FDA.
The FDA asked Hill to cease and desist the promotion, and to respond to the agency's letter by Dec. 17.
According to "The Pink Sheet," Hill President Jerry Roth said the company had already removed the claims from the company's Web site, and declined further comment. A check of Hill's pediatric atopic dermatitis and eczema/atopic dermatitis pages at press time found them to be "under construction."
This news organization and "The Pink Sheet" are owned by Elsevier.