WASHINGTON, March 5: Advertisements for pacemakers, artificial joints and other medical devices should be easy for consumers to understand and not distract them from possible risks, new guidelines from the medical device industry said on Thursday.

The voluntary principles, released by the Advanced Medical Technology Association (AdvaMed), also call upon device-makers to ensure that celebrity endorsements are truthful and to make clear when actors are used.

The US Food and Drug Administration already regulates promotional materials for devices to make sure they include some information about possible risks and do not mislead consumers. The Federal Trade Commission oversees ads for less serious devices such as bandages and other over-the-counter products.

“We see a lot of value in direct-to-consumer (DTC) advertising, but you have to make sure that the information is useful and accurate,” AdvaMed president and CEO Steve Ubl said.

The move comes amid a growing number of consumer-directed ads for medical devices targeting an aging US population even as some groups express concerns about what they see as less stringent oversight.

Already, companies have spent hundreds of millions of dollars touting artificial knees and artery-opening heart stents, including ads from device-makers.

“Historically, there hasn’t been very much medical device direct-to-consumer advertising. ... However, I think you will see more DTC advertising in our space,” Ubl said.

Consumer groups have been pressing the FDA to take a stronger stance against device ads. As with pharmaceutical ads, advocates are concerned that device promotions may give potential patients an exaggerated sense of potential benefits without a clear understanding of potential complications.

Consumers Union has said ads for more serious devices, usually implanted through surgery, should include a warning about possible infection.

In December, the Prescription Project petitioned the FDA over six company videos posted to Google Inc’s YouTube website that did not include necessary warnings.

AdvaMeds guidelines call on device-makers to voluntarily submit TV commercials to the FDA when they air but do not request the FDA to sign off on them beforehand.

Ubl said while the principles apply to all types of media, including websites and online video, the move to submit video to the FDA does not apply to online videos posted to company-owned sites or third-party sites like YouTube.

FDA’s Centre for Devices and Radiological Health Director Daniel Schultz told lawmakers last year that the agency was continuing to monitor device ads for false or misleading content but that it must target its resources to “violations with the greatest public health impact.” —Reuters
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