Medical Device Link.

Originally Published MX January/February 2006

BUSINESS NEWS

Recognizing the lack of attention that has traditionally been paid to regulating direct-to-consumer (DTC) marketing of medical devices, FDA in early November held a public hearing to seek input on whether the agency needs to revise its approach to the promotion of medical products, including restricted devices.

At the hearing, FDA officials heard widely divergent views on whether increased oversight of DTC marketing for medical products is necessary. Among the nearly 20 presenters at the two-day hearing was Marlene K. Tandy, MD, JD, cochair of the advertising and promotion working group of industry association AdvaMed (Washington, DC) and senior counsel for Johnson & Johnson (J&J; New Brunswick, NJ). In her presentation, Tandy conveyed AdvaMed's support for DTC marketing of medical products and the organization's opinion that prereview of DTC marketing materials by FDA should remain optional.

Tandy's presentation was one of only a handful that focused on medical devices. Dominating the meeting were the presentations on the currently hot and controversial topic of DTC marketing for pharmaceuticals.

The hearing's focus on drugs over devices is not surprising in light of the surge in DTC pharmaceutical advertising in recent years. Although medtech manufacturers have shown signs of increasing interest in DTC advertising, their product campaigns and expenditures are minuscule compared with those of the pharmaceutical industry.

However, implications of the slow but steady increase in medical device advertising to consumers was one of the main points FDA hoped to explore at the hearing. In its request for comments, FDA asked, "Is there a way to make information in DTC promotion of medical devices more useful to consumers?"

Responding to the device-focused question on behalf of AdvaMed, J&J's Tandy told FDA panel members that guidance on how device companies can present technical information in a consumer-friendly way would be useful.

Jones

"The device industry is relatively new to the game," says Carolyn Jones, associate vice president of technology and regulatory affairs with AdvaMed. "Drug companies have had a lot more experience with direct-to-consumer advertising. Our suggestion to FDA is that devices need to be viewed in a little different light. The medical device industry has a good track record, although limited, with respect to DTC advertising. Because the medical device industry is a latecomer to the game, it's been able to learn from the mistakes of others."

FDA is accepting comments on the topic of DTC advertising of medical products, including recommendations on how marketing of devices should be handled, until February 28, 2006.

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