FDAnews Device Daily Bulletin

MOUNTING COSTS OF FALSE CLAIMS A WAKE-UP CALL FOR INDUSTRY

July 3, 2006
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Government enforcement agencies are increasing their scrutiny of deceptive advertising practices in the marketing divisions of device and diagnostics firms, an FTC official said June 20.

Companies should work to ensure their product marketers are aware of their obligation to provide complete and accurate information to consumers, Matthew Daynard, a senior attorney with the FTC, told attendees at the Medical Device and Diagnostics Marketing Compliance Congress in Washington, D.C.

Marketing divisions often "have the last word," even overriding the advice of company lawyers, which can lead devicemakers to sign off on false or misleading promotional ads that invite an FTC investigation, Daynard noted.

The commission's jurisdiction is "very simple and very broad: unfair or deceptive ads or practices are prohibited for manufacturers or retailers." Because potential injury to consumers from false or misleading ads can be significant, the basic principle device marketers should follow is "tell the truth," Daynard said.

A promotional claim is defined as "deceptive" when it is likely to mislead consumers, he said. "We don't have to show actual injury any express claim is by definition 'material' to the case," he noted.

For example, withholding adverse information about a product is unfair advertising. "Silence about a known defect can get you in big trouble, because consumers have no way of knowing if there is a defect," Daynard stressed.

Implied claims of effectiveness and claims for "off-label" uses -- conditions the product was not designed to treat or approved by the FDA to treat -- are also red flags, he added. ()a href="http://www.fdanews.com/ddl/33_26/" target=_blank>