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Drugs & Medical Safety Devices

The Prescription Drug User Fee Act (PDUFA) was reauthorized this year. This legislation allows the FDA to collect fees from the drug industry in exchange for meeting a rigid set of deadlines for reviewing new drugs. PDUFA has created a conflict of interest for the agency because the act has made the FDA financially dependent on the industry it is supposed to regulate. We believe this dependence may have contributed to a lowering of FDA standards, and that this may be responsible for the approval of nine drugs since 1992 that were subsequently withdrawn from the market because of the danger they posed to consumers. The only way to avoid this dependence would have been to fund the FDA through appropriations -- unfortunately Congress did not do this.  Instead, it reauthorized PDUFA.

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