Originally Published MDDI January 2004

NEWSTRENDS

Erik Swain

FDA expects to create a policy on what medical device companies should and should not do when advertising directly to consumers, according to an agency official. 

At the Regulatory Affairs Professional Society (RAPS; Rockville, MD) annual meeting in October 2003, Timothy A. Ulatowski, director of CDRH's Office of Compliance, said a guidance document on direct-to-consumer (DTC) advertising from device companies is imminent. At press time, it had not yet been published.

DTC advertising has had a major impact on the pharmaceutical industry. When FDA started allowing drug companies to do more DTC advertising in 1997, the industry flooded television and radio airwaves with campaigns. As a result, consumer habits changed, and many patients for the first time started asking their doctors about specific medications they had seen advertised. One FDA survey showed that 92% of doctors reported that they had had at least one patient who asked about a prescription drug they had seen advertised. 

Whether a similar impact could occur for the device industry is unclear, as many of its products are not sold directly to patients. But, Ulatowski said, it is time for consumers to have more access to information about the devices they use, and to step up efforts to ensure the accuracy of device advertising and marketing. He added that a Web site with DTC-advertising-related warning letters and untitled letters would be created soon. 

“Better information makes better educated and empowered consumers,” he said. “Empowered consumers mean better competition.” He noted that one mantra of FDA Commissioner Mark B. McClellan, MD, PhD, is that “people want accurate, up-to-date, science-based information they can trust.”

FDA's office of chief counsel has been very aggressive in admonishing pharmaceutical firms that advertise improperly, and the same will hold true for device companies, Ulatowski said. “Government's role is to intervene when market forces cannot control the market, and there is imbalance,” he said. “And imbalance occurs when consumers are not provided with truthful and balanced statements.”

CDRH will not have the resources to review every single ad, “but I'll look at what's out there, and prioritize to address those that could cause the most harm,” he said. “Some ad reviews will be able to be conducted during the pre-market phase.”

In developing the guidance, he said, “I'm not going to reinvent the wheel. I'll play off DDMAC [the Center for Drug Evaluation and Research's Office of Medical Policy Division of Drug Marketing, Advertising, and Communications] and then find areas where devices differ.”

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