Tuesday, March 26, 2013

Aggressive Tactics Used To Market High-Tech Medical Devices Examined.

On the front of its Science Times section, the New York Times (3/26, D1, Rabin, Subscription Publication) reports in an investigatory piece, "Internal company e-mails, provided to The New York Times...offer a glimpse into the aggressive tactics used to market high-tech medical devices and raise questions about the quality of training provided to doctors before they use new equipment on patients." For example, according to the Times, "the Food and Drug Administration allowed the sale of the da Vinci [Surgical] system in 2000 under a controversial process called 'premarket notification,' often used to bring medical devices to market without the rigorous trials of safety and efficacy typically required of new drugs." But, "when devices are brought to market this way, the FDA 'cannot require training programs as a condition of clearance,' said Synim Rivers, an agency spokeswoman."

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