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Device Firms Under Pressure To Add More Warnings To DTC Ads

This article was originally published in The Gray Sheet

Executive Summary

Public pressure is increasing on device firms, especially orthopedic implant manufacturers, to include more detailed risk information about their products in direct-to-consumer broadcast advertisements

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FDA Relies On Cognition Research To Spot Misleading Ads – Draft Guidance

FDA is harnessing established science on human cognition to assess whether a device or drug maker's advertisement is misleading, according to a May 27 draft 1guidance document from the agency

FDA Relies On Cognition Research To Spot Misleading Ads – Draft Guidance

FDA is harnessing established science on human cognition to assess whether a device or drug maker's advertisement is misleading, according to a May 27 draft 1guidance document from the agency

DTC advertising bill

House bill introduced May 22 would place a three-year moratorium on direct-to-consumer advertising of devices and drugs, with the exception of products for which HHS affirms a public health need. Sponsored by Reps. Rosa DeLauro, D-Conn., and Jo Ann Emerson, R-Mo, H.R. 6151 would require device and drug firms to distribute corrective materials and pay civil penalties if they violated the moratorium. "Public relations should never trump public health," DeLauro said. FDA is facing increasing pressure to clamp down on excessive ads, including a December petition from the Consumers Union seeking additional warning statements (1"The Gray Sheet" Feb. 18, 2008, p. 5). Separately, an article by two cardiologists in the New England Journal of Medicine earlier this month had criticized Johnson & Johnson/Cordis' ad campaign for its Cypher drug-eluting stent (2"The Gray Sheet" May 19, 2008, p. 14)

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