F.D.A. Rule Limits Role of Advisers Tied to Industry

F.D.A. Rule Limits Role of Advisers Tied to Industry – New York Times

By GARDINER HARRIS
Published: March 22, 2007
WASHINGTON, March 21 — 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.

Advisory boards recommend drugs for approval and, in rare cases, removal, and their votes can have enormous influence on drug company fortunes.

Emphasis mine.

And, are you kidding me?  They aren’t already precluded from ruling on their competitor’s products if they have significant holdings in a company in front of the committee?

I’ve always given the FDA the benefit of the doubt.  Now they just get doubt. 


Comments

  1. I find it funny that the FDA does’nt seem to think that $49,999 dollars is vested interest. Isn’t the bar being set a little to high?