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12:00 AM
Jul 14, 2008
 |  BioCentury  |  Regulation

CDER’s safety chorus

FDA this month provided added color on the increased role and responsibilities of the Office of Surveillance and Epidemiology in working with the Office of New Drugs to address safety issues. There has been a significant shift toward giving an equal voice to agency staff across the disciplines.

Members of OND, which is responsible for drug reviews, and OSE, the agency’s drug safety office, have in the past found themselves at loggerheads over safety. A recent high-profile example is the controversy over the strength of evidence about the cardiovascular risk of diabetes drug Avandia rosiglitazone from GlaxoSmithKline plc.

With Avandia, clinicians at OND believed the signals from meta-analyses of cardiovascular safety were not strong enough to merit withdrawal, and they argued at an advisory committee meeting that these signals should be compared to the risks posed by other diabetes therapies. Epidemiologists at OSE wanted to use absolute safety standards based on a comparison of the drug to placebo to justify removing Avandia from the market.

The committee concluded that Avandia increases cardiovascular risk in diabetes patients, but that it should...

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