The Food and Drug Administration Office of Prescription Drug Promotion recently sent a letter to Aclaris due to false or misleading claims for its direct-to-consumer advertising for Eskata.
In the video released by Aclaris on Eskata, which treats seborrheic keratoses, the FDA says there is a lack of information on the risks associated with Eskata including risk of corneal injuries, chemical conjunctivitis, eyelid edema, severe eye pain and permanent eye injury, as well as skin problems.
The video also claims that lesions go away after one or two treatments, but the FDA found this to be true in less than 10% of patients. The only mention of efficacy data was in superimposed text with “compelling and attention-grabbing before-and-after photographs” of patients.
The OPDP requested that Aclaris stop using all “violative materials” and respond to the FDA as to whether or not it will comply with the request or an explanation as to why the advertising is not a violation of the Federal Food, Drug, and Cosmetic Act.
