• by March 5, 2009

Faced with scrutiny from Congress and criticism from consumer groups, the Advanced Medical Technology Association (AdvaMed) on Thursday issued voluntary consumer advertising guidelines for its 400 members, who sell products ranging from hearing aids and pacemakers to artificial limbs, hip replacements and other implants.

Unlike ads for pharmaceuticals, those for medical devices do not need to be submitted to the U.S. Food and Drug Administration before being aired, published or posted on the Web. AdvaMed's guidelines now call for TV commercials to be submitted voluntarily to the FDA, but not until their first airing. Print and Web ads are included in the policy.

In another significant change, AdvaMed said endorsements and testimonials--including those by celebrities--should now follow guidelines established by the Federal Trade Commission, an agency that, unlike the FDA, does not have jurisdiction over ads for the "restricted devices" sold by AdvaMed members. Under those established FTC guidelines:

• Endorsements must reflect the honest opinions, findings or experience of the endorser, who must be an actual user of the product unless some other relationship is disclosed

• The endorser's representations must be able to be substantiated as if made directly by the manufacturer

• Endorsements and testimonials must be representative of a typical user experience, or clearly disclose when they are not

As reported by the Associated Press, recent celebrity endorsers for hip replacements alone have included Duke University basketball coach Mike Krzyzewski for Johnson & Johnson and Olympic gymnastics champion Mary Lou Retton for Biomet.

A J&J commercial featuring Krzyzewski was singled out six months ago during a Senate hearing on medical device advertising because of its depiction of numerous hip replacement patients participating in various sports.

The new AdvaMed "guiding principles" also ask members to:

• Use language appropriate for the intended audience (often the aging portion of the population) and present technical information in consumer-friendly language

• Encourage patients to speak with their health care professional "in greater detail"

• Disclose when actors are portraying health care professionals, or when actual health care professionals are being paid for their appearance

• Include reference to where consumers can get additional product-labeling information.

• Educate health-care professionals about new devices prior to the launch of their ad campaigns

• Revise or withdraw advertising if new valid info regarding the device indicates a previously unknown serious safety risk

In a statement reported by both AP and Dow Jones, Wisconsin Sen. Herb Kohl, whose Special Committee on Aging held those September hearings, said: "I will be paying close attention to how individual companies implement AdvaMed's strengthened policies to ensure that consumers interests are protected."