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Waxman requests marketing, research info from Boston Scientific, others

Device Regulation Alert: Safety, Compliance and Reimbursement News, March 12, 2007

Safety concerns and allegations of off-label use and inappropriate marketing are the focus of letters that Representative Henry Waxman (D-CA) sent to several medical device and pharmaceutical companies last week.

Waxman, chairman of the Committee on Oversight and Government Reform, requested information from Boston Scientific, Cordis Corporation, Eli Lilly, AstraZeneca, and Cephalon about their research and marketing. The requests are part of the committee's oversight of the industry's marketing practices, according to the Web site.

Waxman sent letters to Boston Scientific and Cordis Corporation about their drug-eluting stents. The letters to both companies cited "concerns about the safety and off-label use of drug-eluting cardiac stents" that were raised at an FDA panel. According to the letter, the panel in question was the Circulatory System Devices Panel meeting that took place on December 7-8, 2006. Click here to read more about that panel meeting.

Go to the Committees Web site to read the letters from Waxman and find out which information and documents the Committee has requested.

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