[19970912]97-838E_1992年处方药使用费法案：对新药上市的影响.pdf

P.L. 102-571.1Congressional Research Service The Library of CongressCRS Report for CongressReceived through the CRS Web97-838 ESeptember 12, 1997Prescription Drug User Fee Act of 1992:Effects On Bringing New Drugs To MarketDavid J. CantorSpecialist in Industry EconomicsEconomics DivisionSummaryThe Prescription Drug User Fee Act of 1992 (PDUFA) enabled the Food and DrugAdministration (FDA) to assess user fees on research-based pharmaceutical companiesto be used solely to accelerate the process for reviewing and approving applications fornew drugs. In at least two respects there have tangible accomplishments. First, since1993, one-third less time was required to review and approve new research-based drugsthan in the years prior to PDUFA implementation. Second, the number of new drugsapproved by FDA rose by one-third. But PDUFA was not intended to and does notaddress other related issues of the total regulatory process for new drug development andapproval, pricing of new drugs, or the approval of generic drugs. BackgroundThe Food and Drug Administration (FDA) has responsibility for the overseeingaspects of the development of and the approval to market new and generic drugs in theUnite