Botox Cosmetic ads cited by FDA
This article was originally published in The Rose Sheet
Executive Summary
Allergan's Botox Cosmetic (botulinum toxin A) "WOW" TV reminder ad discloses anti-wrinkle agent's indication by discussing age, focusing on complexion and image and directing consumer to a dermatologist or plastic surgeon, FDA says in a Sept. 5 letter to firm, requesting ads be discontinued. Under FDA rules, reminder ads need not include a full summary of side effects as long as the product's use is not disclosed. However, Allergan's ad "strongly suggest[s] that the product is intended to treat the signs of aging or glabellar lines," FDA says and should therefore be revised and submitted to the agency for review prior to airing. In a statement Sept. 12, Allergan said it plans to respond to FDA's concerns by Sept. 16. Botox was approved in April (1"The Rose Sheet" April 22, 2002, In Brief)...