Sunday, September 6, 2009

FDA shenanigans

FDA user fees:
one of many overviews available in the press , this one from the

Washington Post

Industry fees pay for more than half the drug-review program, with funds appropriated by Congress making up the rest. In fiscal 2006, Congress appropriated $219 million for the program, and user fees came in at $304 million.

From the FDA's website:

Fee Revenue Amount for FY 2008, Including Adjustments for Workload The total fee revenue amount for FY 2008 is $459,412,000, based on the fee revenue amount specified in the statute, including additional fee funding for drug safety and adjusted for inflation and changes in workload.

From the Wallstreet Journal

Article from a whistleblower within the FDA

In August 2004, Graham told his supervisors that, in light of his research, high-dose prescriptions of the painkiller Vioxx, which appeared to triple heart attack rates, should be banned. They told him to be quiet. Their reasoning was circular: That's not the FDA's position; you work here; it can't be yours. Dr. John Jenkins, the FDA director of new drugs, argued that because Graham's findings didn't replicate the drug's warning label, Graham shouldn't be raising the warning. Another supervisor, Anne Trontrell, called Graham's position "particularly problematic since FDA funded this study." Days after Graham's pronouncement, the agency approved Vioxx for use in children.But Graham was right. The following month, Merck pulled Vioxx from the market after its own research found that the drug, even when taken at low dosages, doubled the risk of heart attack. The announcement provided Graham no vindication. With a scandal on the horizon, the FDA brass now saw him as a danger. They couldn't silence the message, so they tried to take out the messenger.

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