From the New York Times:
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 F.D.A.’s powerful advisory committees.
Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though 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 present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter, though he would not say how many. The rules are among the first major changes made by Dr. Andrew C. von Eschenbach since he was confirmed as commissioner of food and drugs late last year.
“The $50,000 threshold is something that we think strikes an appropriate balance between” getting smart advisers and reassuring the public that their advice is not tainted, Dr. Lutter said.
The changes are intended to respond to a growing chorus of critics who contend that drug and device makers have hijacked the Food and Drug Administration’s approval process by paying those who serve on the agency’s advisory panels.
I am not sure what is more disgusting — the FDA openly admitting that a “significant number” of current agents would be affected by this amendment, or the fact the agency is proud of its new rule.
The FDA has responded to critics by slapping them in the face. I guess the agency thinks that $49,999 dollars from a drug company wins no influence. If that’s the case, I would hate to know how much agency experts were receiving before the new rule.
