FDAnews Drug Daily Bulletin

FDA CITES IMPROPER CLAIMS FOR SKIN GRAFT PRODUCT

May 25, 2006
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Problematic online advertising of a skin graft product is the subject of an official letter the FDA sent to LifeCell, Branchburg, N.J., and Wright Medical Technology, Arlington, Tenn.

The "Violative Advertising and Promotional Labeling Letter" sent by the Office of Compliance and Biologics Quality, a part of CBER, concerns the website, http://www.wmt.com/graftjacket (http://www.wmt.com/graftjacket), that advertises the companies' joint skin graft product, GRAFTJACKET. According to the letter, GRAFTJACKET is made from human donor skin from which the epidermis and dermal cells have been removed to create an acellular dermis.

The website's claims for the product exceed what is permitted under Section 361 of the Public Health Service Act (PHSA) and 21 CFR Parts 1270 and 1271, according to the letter. Among the requirements of these regulations is that a human cell, tissue and cellular and tissue-based product (HCT/P) must be "minimally manipulated," so that the "processing that does not alter the relevant biological characteristics of cells or tissues."

The letter explains that this minimal manipulation criterion applies to the decellularization of the dermis used to prepare GRAFTJACKET -- as long as its use is restricted to wound covering. But the website goes beyond that by promoting the product for wound repair and healing.