Abbott Laboratories said it will embed safety information about its Xience heart device into a YouTube video spot, a disclosure made hours after a consumer group complained the spots ran afoul of U.S. Food and Drug Administration rules on product marketing.
"Abbott's practice is to comply with all regulatory requirements and to provide patients and consumers with accurate and complete product information," Abbott said in a statement to the Tribune on Wednesday, adding that it had done nothing wrong. "All Abbott's Xience V videos on YouTube were posted in July 2008 with prominent links to the 'Brief Summary of Instructions for Use,' which details the product's risk and safety information. To avoid any problems in the future, we will embed safety and risk information in the videos moving forward."
The Boston-based Prescription Project, long a critic of drug and medical device industry marketing, said Wednesday that such videos should be regulated by the FDA and include safety warnings like other health industry products marketed in other venues.
Thursday, December 04, 2008
Abbott - Xience: safety first!
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