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Prescription Drug User Fee Act of 1992: Effects on Bringing New Drugs to Market

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Publication Date: September 1997

Publisher(s): Library of Congress. Congressional Research Service

Series: 97-838

Topic: Manufacturing and industry (Pharmaceutical industry)


The Prescription Drug User Fee Act of 1992 (PDUFA) enabled the Food and Drug Administration (FDA) to assess user fees on research-based pharmaceutical companies
to be used solely to accelerate the process for reviewing and approving applications for new drugs. In at least two respects there have tangible accomplishments. First, since
1993, one-third less time was required to review and approve new research-based drugs than in the years prior to PDUFA implementation. Second, the number of new drugs approved by FDA rose by one-third. But PDUFA was not intended to and does not address other related issues of the total regulatory process for new drug development and approval, pricing of new drugs, or the approval of generic drugs.