This year, Congress had to consider reauthorization of the Prescription Drug User Fee Act (PDUFA), which it must do every 5 years. Under PDUFA, the major funding for the review of new drugs by the Food and Drug Administration (FDA) comes from user fees paid by pharmaceutical companies. This mechanism has been controversial because, although it was designed to accelerate the drug-approval process and can make new drugs available to patients without delay, it has directed no money to the postmarketing assessment of drug safety. In addition, some believe that user fees pose a conflict of interest for the FDA. Nonetheless, to ensure that the FDA has adequate financial resources, both the House and the Senate versions of the bill not only maintain these user fees but increase them (with some of the money now directed to safety assessment).

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