The Advanced Medical Technology Association (AdvaMed), has released advertising standards for medical-device makers. AdvaMed’s guidelines cover all device DTC ads, including broadcast, print and internet. Medical device manufacturers have agreed to submit television advertisements to the US Food and Drug Administration (FDA) for review as part of advertising rules that attempt to address Congressional criticism of ads for products like heart stents and knee implants.
The move comes after some senators threatened to push legislation to tighten medical device advertising regulation, which is currently split between the Federal Trade Commission and the Food and Drug Administration. The FDA generally has jurisdiction over medical devices that are implanted inside the body such as heart stents and artificial knees and hips.
However, advertising rules for medical devices aren’t as strict as those for drug advertisements, which require companies to submit ads to the FDA for review before being disseminated and outline how risks and benefits of a drug can be advertised.
Congress would need to enact legislation to give the FDA authority to regulate device advertising in a manner similar to drug products.
Steve J. Ubl, chief executive of AdvaMed, said companies should submit television ads at the time they are first broadcast, which would alert the agency that a certain ad is being aired. He said companies would be free to submit ads prior to broadcast.
He said he believes the voluntary guidelines address the concerns raised by lawmakers including Herb Kohl, D-Wis., chairman of the Senate Special Committee on Aging.
Kohl said he would “pay close attention to how individual companies implement AdvaMed’s strengthened policies.” At a hearing on the issue in September, Kohl said he would give the industry a chance to beef-up its own policies before taking legislative action.
The FDA can take necessary legal action against a company for a misleading device ad once the ad has been disseminated. Medical device ads are required to state what a device is used for and include any side effects. But device advertising rules don’t have the same “fair balance” requirement drug advertisements must adhere to that require both the benefit and risk information to be equally spelled out.
The advertising principles outlined by AdvaMed seek to present risk information in a manner free from distraction and to use consumer-friendly language appropriate for the intended audience. The rules also state that doctors should be educated about new medical devices before such devices are advertised to the public.