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Drug-review fees help industry shape FDA agenda

Tuesday, September 5, 2006

According to the Wall Street Journal, the Food and Drug Administration is bargaining with the pharmaceutical industry for an increase in fees used for reviewing new drug applications-- a move experts say will give the industry a greater role in shaping the priorities of its regulator. "There is no doubt that user fees give the industry leverage on setting the agency's priorities, because of the negotiating process," says Dr. Kessler, former head of the FDA, and now dean of the medical school at the University of California, San Francisco. "There are significant risks, especially when a growing percentage of the budget comes from user fees." For the next five-year agreement, which will begin Oct. 1, 2007, fees could cover 66 percent or more of the drug-review budget.

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