Thursday, March 22, 2007

FDA dilutes advisory conflict


There's absolutely we can all delve deeply into the rules of different agencies. That said, does it surprise you this was not already the rule in the FDA?
Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company's products under new rules announced Wednesday for the FDA's powerful advisory committees.

Such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed will no longer be allowed to serve on the committees, although those who receive less than that amount in the prior year can join a committee and participate in its discussions.

A "significant number" of the agency's advisers will be affected by the new policy, said the FDA's acting deputy commissioner, Randall Lutter, although he would not say how many. The rules are among the first major changes made by Andrew von Eschenbach since he was confirmed as Food and Drug Administration commissioner late last year.

Before it was something like this?

"Thank you Mary for your vote on whether to approve this new Pfizer drug."

"Joe, how's that new boat?"

"Its just great, Randy. Handles like a dream. I named it the Pfizer Pfloat. I uh, guess I vote to approve. Can't bite the old hand that feeds."

(General laughter all around)

(read more)

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