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Wednesday, September 21, 2005

Senate eyes FDA conflict of interest probe

Associated Press

Senators asked Congress' investigative arm Wednesday to look into the Food and Drug Administration's practice of letting scientists serve on its advisory panels even if they have conflicts of interest.

"We are concerned about the process that supports FDA's decisions to waive conflicts of interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors," senators said in a letter sent Wednesday to the Government Accountability Office.

It was signed by Sen. Mike Enzi, R-Wyo., the chairman of the Health, Education, Labor and Pensions Committee, and panel members Edward M. Kennedy, D-Mass., and Richard Durbin, D-Ill.

Members of FDA advisory committees are required by law to be free of conflicts of interest concerning products they discuss and recommend for approval. The FDA, however, can grant a waiver if an adviser's scientific expertise outweighs the risk of a conflict, or if the financial interest is small.

"These practices appear to have undermined the public's faith in the objectivity and fairness of FDA's advisory committees," the senators said in the letter.

Senators noted allegations of conflicts among the FDA panels that studied Cox-2 inhibitors, painkillers that have potential heart risks, and silicone gel-filled breast implants.

Posted by Becca


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