September 17th, 2008

Congress Scrutinizes Consumer Ads for Medical Devices

By Jacob Goldstein
WSJ Health Blog

Some medical device big shots were on Capitol Hill this morning, talking to the Senate about companies pitching their wares directly to consumers.

Sen. Herb Kohl, a Dem whose aging committee held the hearing, has been looking into drug and device advertising for a while now. In his closing statement today, he laid down the gauntlet for device makers and the FDA, suggesting the possibility of an ad moratorium on new devices, to allow doctors to familiarize themselves with the product before patients start coming in asking about things they’ve seen on TV:

Already in the House, Chairman Dingell and others are asking for such moratoriums on DTC ads for pharmaceuticals. We’ve heard testimony this morning that similar restrictions may be necessary for DTC medical device ads. What we do in the near term will be dependent on the pro-active actions of FDA and industry.

As it is, surgeons apparently don’t think much of the ads. The Senators heard testimony from Kevin Bozick, a UCSF orthopedic surgeon and member of the board of the American Association of Orthopedic Surgeons. Bozick cited this study of his, which found that 74% of surgeons thought the ads “negatively impacted their relationships with patients,” and 84% thought patients who had seen the ads had “unrealistic expectations regarding the benefits” of the devices.

Device makers got to have their say in the person of Stephen J. Ubl, CEO of the indsutry group AdvaMed. He said the ads let patients know about options they might be unaware of, and added that “the FDA and the FTC already have ample legal authority to regulate false or misleading advertising for medical devices. FDA and FTC already have the power to regulate.”


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