FDA Limits Role of Advisers in Industry
Advisers to the U.S. Food and Drug Administration who are given money from a drug or a device maker will be blocked from voting on whether to approve that company's products. The new rules were announced on Wednesday. Doctors who are given more than $50,000 from a company, or a competitor of that company, whose product is under review, will not be allowed to serve on review committees. However, those who are given less than $50,000 in a prior year will be allowed to join a committee and participate in discussions.
The FDA's acting deputy commissioner, Randall W. Lutter, said that a "significant number" of the agency's present advisers would be affected by the new policy. “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," Lutter said.
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