The Division of Drug Marketing and Communications (DDMAC) warned Allergan about a journal ad for Aczone, and Galderma Laboratories about two professional visual aids for Tri-Luma Cream.
In a letter dated August 18, DDMAC told Allergan that a journal ad (here
, in pdf) for Aczone, a topical acne medication, was false or misleading because of an overstated efficacy and the omission of material facts and risk information. In the letter, DDMAC singled out a claim made in the advertisement – that Aczone “works fast – 24% reduction in inflammatory lesions at 2 weeks" – calling the statement “a complete misrepresentation of the results of the Draelos study.”
The letter goes on to describe a “grossly” overstated efficacy in the ad, which presents only the most favorable result for Aczone and ignores the placebo response. Additionally, the ad failed to include drug interaction information about Aczone, related to “temporary local yellow or orange discoloration of the skin and facial hair,” according to the letter
. Cathy Taylor, a spokesperson for Allergan, confirmed that the violative ad ran in journals during the months of March, April and May, but has not been used since. Taylor declined to name which agency worked on the ads.
Another DDMAC warning letter sent to Galderma Laboratories and dated August 18 took issue with two professional visual aids (here
, in pdf) for Tri-Luma cream, a short-term treatment for facial melasma, or skin discoloration. The visual aids were considered violative based on recommended or suggested uses for Tri-Luma that were not FDA-approved, unsubstantiated claims that overstated the efficacy of the product, and dissemination of the visual aids with an unapproved version of the product labeling.
“These violations are extremely concerning from a public health perspective because they suggest that Tri-Luma is useful in a much broader range of patients and conditions than has been demonstrated by substantial evidence or substantial clinical experience, and that it is safer and more effective than has been demonstrated [by same]”, DDMAC admonished in the letter