Prescription Drug User Fee Act
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.[1]
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.[1] Another 2002 statute extended user fee policies to cover the approval process for medical devices. In 2007, the FDA was expected to collect $259,300,000 in industry user fees.[2] The PDUFA provisions were scheduled for reauthorization in 2007, and the FDA 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.[3]
Scale of fees
FDA calculates the fees for the following year based on the expected work (applications etc) and the amount it wants to raise from the fees. For 2008 the application fees are :
- $1,178,000 per full application requiring clinical data,
- $589,000 per application not requiring clinical data or per supplement requiring clinical data.
There are also establishment fees and product fees.[4]
References
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- ↑ 1.0 1.1 [1] GAO-02-958 Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities
- ↑ [2] Information about the PDUFA program from the FDA
- ↑ [3] FDA press release on PDUFA IV recommendations
- ↑ http://www.fda.gov/OHRMS/DOCKETS/98fr/07-5052.pdf "Prescription Drug User Fee Rates for Fiscal Year 2008"
