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Related Topics >> Avandia | FDA | FDA approval | Charles Grassley

Grassley: FDA should air dissent

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By now, we're all accustomed to Sen. Charles Grassley's occasional tirades against the FDA. But let's just say that some of it starts getting through, and the FDA changes its approval processes accordingly. As The In Vivo Blog points out, all advisory committee sessions might end up looking like this summer's Avandia confab, in which disagreement within the agency's reviewers erupted for the public to see.

To Grassley, that dissent is a good thing. Why not let the agency's expert advisors hear a spectrum of opinion on the drugs in question, rather than a consensus pre-digested for their consumption? "Any advisory committee cannot perform its duties adequately if it is not working with all available information and perspectives," the Senator wrote to FDA Commissioner Andrew von Eschenbach as ranking member of the Senate Finance Committee.

- read Sen. Grassley's letter to the FDA (.pdf)
- see this item from The In Vivo Blog


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