Monday, December 8, 2008

Prescription Project Says DTC Ads Violate FDA Rules

Personally, I dislike direct to consumer (DTC) ads for myriad reasons that I won't go into. I digress. Here's the real news. A consumer watchdog group, The Prescription Project, questioned the legality of several advertisements for medical devices that appear on YouTube, and they want regulators to crack down on the promotions. The Project claims, DTC advertisements for several medical devices on the video Web site YouTube violate federal regulations because they don't include required warnings and disclosures about potential risks. They cite ads for Abbott's Xience V, a drug-coated stent; Medtronic's Prestige Cervical Disc, a spinal implant; Stryker's Cormet hip-resurfacing system; and they want the ads removed from YouTube. The Project's policy director states, "The videos raise serious questions about whether drug and device companies are using the Internet to skirt laws that safeguard consumers." The FDA has roughly six months to respond to the Project's petition.

For a super concise briefing, read this quick read on the Pharma 2.0 blog, "Prescription Project targets medtech ads on YouTube."

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