FDA Holds Hearing on DTC Device Marketing

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.

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 posed the question, “Is there a way to make information in DTC promotion of medical devices more useful to consumers?” The notice went on to state, “Many of the Federal Food, Drug, and Cosmetic Act’s requirements apply to both drug and device promotion. Hence, many of the principles used to regulate prescription drug advertising also apply to device advertising. Nevertheless, there are no regulations pertaining to restricted device advertising. FDA is committed to ensuring that consumers have accurate and nonmisleading information concerning restricted medical devices.”

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.

AdvaMed’s Jones: Distinguishing drug from device.

“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 late-comer to the game, it’s been able to learn from the mistakes of others.”

The lack of attention paid to device advertising during the hearing, Jones says, should send a message to FDA. “That should give FDA a clue,” she said. “If it isn’t broke, hopefully they won’t try to fix it.”

That being said, there is concern within the medtech industry that a crackdown on the DTC advertising practices of pharmaceutical companies could spread to the marketing of devices. In light of recent safety concerns over widely promoted drugs such as Vioxx, there has been a flurry of activity in the federal government calling for increased regulation of drug-related consumer communications.

In early July, U.S. Senate majority leader Bill Frist (R–TN) called for a two-year moratorium on DTC advertising of new pharmaceuticals. In making his case, Frist contended that such advertising “can lead to inappropriate prescribing and fuel prescription drug spending” and that the ads “oversell benefits and undersell risks.” Similarly, in late September, Representatives Rosa DeLauro (D–CT) and Jo Ann Emerson (R–MO) introduced the “Responsibility in Drug Advertising Act of 2005” in the House. This new legislation would impose a three-year moratorium on DTC marketing of new pharmaceuticals. Nothing in the current legislation, however, suggests it would apply to the medical device market.

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

© 2005 Canon Communications LLC

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