Conflicting opinions on DTC converge at FDA hearings

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An FDA panel gathered in an obscure subterranean auditorium in Washington, D.C., Tuesday and Wednesday to hear public comment on direct-to-consumer advertising of Rx drugs--commentary that included a written submission from Astra- Zeneca calling for a mandatory FDA review of all DTC ads prior to broadcast or print, and harsh criticism from consumer groups and academia.
The two-day public hearings played host to a collision of opinions from nearly 40 speakers. Comments from industry and industry groups stressed the preservation of DTC advertising as a way to create patient awareness of medical conditions and initiate dialogue with doctors, while consumer groups suggested that the advertising format was often misleading to their constituencies.
Ruth Day, an associate professor at Duke University who specializes in the study of consumer understanding of drug ads in the school's psychology department, argued that risk information should figure more prominently in DTC ads. "Risk information is physically present but functionally absent," she said.
William Vaughan, senior policy analyst at Consumers Union, the nonprofit publisher of the magazine Consumer Reports, called on the FDA to institute a two-or three-year moratorium on advertising of new drugs, the pre-approval of DTC and DTP ads, giving the FDA civil monetary penalty authority to enforce truth in advertising and the addition to all DTC ads of a toll-free MedWatch phone hotline and Web site to report adverse drug reactions.
Diana Zuckerman, president of the National Research Center for Women & Families, after presenting DTC print ads for Vioxx and Adderall XR that depicted women in idyllic situations, suggested that the FDA consider regulating the selection of ad images. "Of course it
would be great to say 'no photographic images.' Words only. If that were possible, that would be a terrific solution."
Pat Kelly, president of Pfizer's U.S. pharmaceuticals division, argued during Tuesday's testimony that DTC advertising helps patients work with their healthcare providers to make more-informed decisions about their health. "It should not be viewed as a comprehensive health information source that leads consumers to think that they don't need any more information."
On Wednesday, Scott Lassman, asst. general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), told FDA panel members that DTC advertising "serves a valuable role in educating patients about the limitations and risks associated with certain therapies." Lassman said that the industry trade group introduced its voluntary DTC guidelines in July to ensure the marketing method remains as an important tool for "conveying useful health information to patients."
Any changes to the FDA's policy are not likely to happen until at least spring 2006. The agency will keep open the docket for public comment on the matter until the end of February, said Tom Abrams, head of the FDA's Division of Drug Marketing and Communication and moderator of the hearings.
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