Prescription Drug User Fee Act Totally Explained

Everything about Prescription Drug User Fee Act totally explained

The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process. A 2002 General Accounting Office (GAO) report found that PDUFA funds allowed the FDA to increase the number of new drug reviewers by 77 percent in the first eight years of the act, and the median approval time for non-priority new drugs dropped from 27 months to 14 months over the same period.

Reauthorizations

In response to concerns that the PDUFA mandates had unintentionally reduced the resources available to the FDA for non-approval-related activities, the second congressional reauthorization of the act in 2002 (PDUFA III) included amendments allowing user fees to be allocated for post-marketing surveillance of drug safety as well. Another 2002 statute extended user fee policies to cover the approval process for medical devices. In 2007, the FDA is expected to collect $259,300,000 in industry user fees. The PDUFA provisions are scheduled for reauthorization in 2007, and the FDA has requested fee increases to cover increased reviewer workload and expanded post-marketing safety initiatives, as well as the authority to apply user fees to the monitoring of direct-to-consumer drug advertising. ====

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