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, c ochair 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, as well as media coverage, were the presentations on the currently hot and controversial topic of DTC marketing for pharmaceuticals. Opinions heard by the FDA panel ran the gamut, with testimony from representatives of pharmaceutical companies, healthcare organizations, research groups, consumer advocacy organizations, and the public.

Pfizer's Kelly: DTC ads improving public health.

Pat Kelly, president of the U.S. pharmaceutical division of Pfizer (New York City), emphasized the notion that consumer-directed advertising of drugs advances public health by increasing awareness of medical conditions and motivating consumers to discuss symptoms with their doctors. He called on FDA to expand rather than reduce the communication options available to manufacturers. He also urged the agency to work with companies to ensure that consumer communications are helpful and understandable.

On the other side, representatives from consumer advocacy groups called on FDA to require medical product advertisements to be approved by the agency before being broadcast or printed. These organizations also said pharmaceutical manufacturers should be required to provide more information on risks and benefits when products are marketed directly to consumers.

Not all testimony followed predictable patterns, however. In written testimony presented at the hearing, AstraZeneca (London), the maker of Nexium, broke from its pharmaceutical peers by opining that all DTC ads should be submitted to FDA before running.