FDA warns Allergan, Galderma on marketing

Two companies have landed themselves in hot water for the way they've marketed skin drugs. Allergan got a warning letter from FDA on its acne treatment Aczone, and Galderma was slapped around a bit for its promotion of a hyperpigmentation treatment.

The details: FDA says Allergan overstated the effectiveness of Aczone in a print ad and left out risk factors to boot. The agency said the ad "is a complete misrepresentation" of the study results it quotes. In the ad, Aczone is said to offer a 24 percent reduction in inflammatory lesions within two weeks--but the ad neglects to mention that placebo offered a 22 percent improvement, which makes the real effect of Aczone more along the lines of 2 percent. The company will no longer be allowed to use that advertisement, and it has until the end of this week to respond in writing. 

But Galderma's infraction appears to be the more severe: The company actually distributed the wrong labelling info with its Tri-Luma product. In this false label, the drug's propensity to cause birth defects when used by pregnant women was completely omitted, BNet Pharma reports. FDA also says the company distributed "visual aids" that said the cream could enhance the results of glycolic acid peels, when in reality, the two together can actually cause hyperpigmentation.

The agency said it was "extremely concerned" about the "numerous alarming differences" between the FDA-approved label and the label Galderma had been distributing. It's calling on the company to come up with a plan for corrective publicity.

- see the BNet Pharma post on Aczone
- get more from Bizjournals.com
- read BNet's Galderma piece

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