REGULATORS TO RESOLVE COMPLIANCE ISSUES CONCERNING FIRM'S AD CLAIMS

The National Advertising Division (NAD) of the Council of Better Business Bureaus has referred advertising for the GraftJacket, a wound-care product, to the FTC and the FDA for review, according to NAD.

Advertising for the GraftJacket was initially challenged by Organogenesis, which makes Apligraf, another wound-care device.

The GraftJacket manufacturer, Wright Medical Technology, made "a bona fide effort to modify its advertising" in accordance with a previous NAD recommendation, with the exception of website advertising that includes a "clinical comparison" chart, NAD said.

The comparison claims that GraftJacket closes 85 percent of wounds after just one application, compared with 56 percent after up to five applications with Apligraf and 30 percent after up to eight applications with a third product, Dermagraft, NAD said.

The comparative tables suggest the products "are comparable and subject to the same regulatory standards of proof when the clinical methodologies and testing criteria were significantly different," NAD said.