"Every last dime spent on advertising is passed on to the consumer." Senator Herbert Kohl, Wisconsin, stated at a hearing today on DCT Advertising by Medical Device Companies: Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?
Direct to consumer advertising is quite small according to TNS Media Consultants and accounted to only $193 million in 2007. For Cardiac Medical Devices DTC is a very recent phenomena according to William Boden, MD Chief of Cardiology at University of Buffalo with the first add being rolled out on November 22, 2007 during a Dallas Cowboys – New York Jets game by Johnson and Johnson for the Cypher coronary stent titled “Life Wide Open”.
Three academic researchers and Consumers Union comprised the first panel and presented "evidence" that current DTC for devices was growing and needed further regulation. Although virtually none of their so-call evidence meets current standards for research, no member challenged it. They also want to be the ones who decided how DTC advertising should be done.
Daniel Schultz, MD, Director Center for Devices and Radiological Health, explained how FDA and FTC shared regulatory authority, and how the FDA regulation of restricted devices compared with FDA drug regulation.
At one point, Senator Kohl asserted "Every last dime spent on advertising is passed on to the consumer." and "Is it time to reconsider that advertising “and ban it like in other countries? Dr. Schultz reply is "Most consumer advertising is not a bad thing." He discussed ads for glucose monitors reminded patients to manage their disease and follow their doctors instructions. Then, "At the end of the day, the decision rests with doctors and their patients."
Schultz also refused invitations by Kohl to seek more legislative authority. Instead, Schultz said that while he thought regulation of device advertising was important, his job was to manage all device regulation in light of the public health and his available resources. If further resources were given the agency, he said much thought would be required to determine how to regulate it effectively and efficiency.
While not denigrating existing regulation of device advertising, he called into question the value of some current labeling regulation, wondering aloud if the resources spent parsing the words used on labels were well spent.
Key Links to Testimony
Kevin Bozic, MD., Professor of Orthopedic Surgery, University of California, San Francisco, CA
William Boden, M.D., Professor of Medicine and Public Health, University of Buffalo, Buffalo, NY and George Diamond, M.D., F.A.C.C., Senior Research Scientist, Emeritus, Cedars Sinai Medical Center, Los Angeles, CA
Ruth Day, Ph.D., Director, Medical Cognition Laboratory; Senior Fellow, Duke Aging Center, Durham, NC
Ami Gadhia, Policy Counsel, Consumers Union, Washington, DC
Daniel Schultz, Director, Center for Devices and Radiological Health, Food and Drug Administration, Washington, DC
Stephen Ubl, President and Chief Executive Officer, AdvaMed, Washington, DC
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