FDA lukewarm to new safety warning system

Despite the FDA's current push for better drug safety data, the agency has responded with only lukewarm enthusiasm to Medicare's proposal that it track the drug reactions of beneficiaries. Medicare chief Mark McClellan believes he can combine billing and healthcare data that will spot drug reaction trends. That kind of data, he believes, would have gone a long way to discovering the safety problems now linked to Cox-2 inhibitors. The FDA, though, appeared noncommittal about the proposal, saying it was too early to decide for or against the initiative.

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