Looking to head consumer advocates, regulators and members of Congress off at the pass, the Advanced Medical Technology Association came up with a set of guidelines for medical device makers’ direct-to-consumer marketing campaigns.
The issue has attracted the attention of consumer advocates after high-profile marketing campaigns by Johnson & Johnson and Biomet featuring Duke University basketball coach Mike Krzyzewski and former Olympic gymnast Mary Lou Retton.
“We see a lot of value in direct-to-consumer advertising, but you have to make sure that the information is useful and accurate,” AdvaMed president and CEO Steve Ubl told the Reuters news service.
Although federal Food and Drug Administration currently regulates promotional materials for devices by ensuring that they include information about possible risks, and the Federal Trade Commission oversees advertisements for smaller devices such as bandages and other over-the-counter products, consumer groups are pushing for stricter limits.
DTC marketing of medical devices has also attracted attention on Capital Hill, where Sen. Herb Kohl convened hearings on the practice last fall. The Wisconsin Democrat said he is concerned that the advertising might under-emphasize the risk of complications associated with implanted medical devices.
In an effort to forestall legislative action, AdvaMed issued guidelines for medical device manufacturers to sue in their DTC campaigns.
The ads should not minimize risk information, according to the guidelines, and device companies should make sure physicians know all the risks and benefits associated with a product before embarking on a DTC campaign.
“I will be paying close attention to how individual companies implement AdvaMed’s strengthened policies to ensure that consumers’ interests are protected,” Kohl told The Associated Press.