FDA Policy/General

Aclaris Video Misbrands Eskata: FDA

A direct-to-consumer video for Aclaris’ Eskata (hydrogen pyroxide) topical solution and its corresponding script make false and misleading claims and/or representations about the risks and efficacy of the drug, according to a 6/14 notice of violation from the CDER Office of Prescription Drug Promotion (OPDP). The letter says the “video is especially concerning from a public health perspective because it fails to include information regarding the serious risks associated with Eskata, which bears Warnings and Precautions related to the risks of serious eye disorders (such as permanent eye injury including blindness) in the case of exposure to the eye and severe skin reactions including scarring.”

Eskata is indicated for treating seborrheic keratoses that are raised. The most common adverse reactions associated with its use are erythema, stinging, edema, scaling, crusting, and pruritis.

OPDP says its 3/29/18 advisory comments addressed draft Aclaris presentations for Eskata and recommended the video be revised to not omit material information about its risks or otherwise misrepresent important risk information. It also recommended that the presentations be revised so that they did not overstate Eskata efficacy.

“We are concerned that Aclaris is promoting Eskata in a manner that fails to adequately present the serious risks of the drug or describe the efficacy of the drug in a truthful and non-misleading manner despite this direction from OPDP,” the letter says.

The letter details objections OPDP has to the presentation of both risk and efficacy information and calls on Aclaris to immediately stop violating the Federal Food, Drug, and Cosmetic Act in the ways described in the letter. The company was told to provide a complete list of promotional materials that contain violations such as those described and a plan for discontinuing use of such materials.

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