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Impact of the Prescription Drug User Fee Act of 1992 on the Speed of New Drug Development

Impact of the Prescription Drug User Fee Act of 1992 on the Speed of New Drug Development. Kenneth I Kaitin, Ph.D. Director, Tufts Center for the Study of Drug Development FDA Public Hearing on PDUFA Washington, D.C., September 15, 2000.

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Impact of the Prescription Drug User Fee Act of 1992 on the Speed of New Drug Development

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  1. Impact of the Prescription Drug User Fee Act of 1992 on the Speed of New Drug Development Kenneth I Kaitin, Ph.D. Director, Tufts Center for the Study of Drug Development FDA Public Hearing on PDUFA Washington, D.C., September 15, 2000

  2. Regulatory Initiatives to Speed Availability of High Priority Drugs • Subpart E Procedures (1988) • Accelerated Approval Regulations (1993) • Cancer Initiatives (1996)

  3. Development Times for Accelerated, Subpart E, and Other NCE Approvals, 1995-99 Source: Tufts CSDD Approved NCE Database, 2000

  4. Mean Clinical and Approval Phases by Therapeutic Class, 1995-1999 9.3 8.4 8.1 7.9 7.8 7.5 6.3 3.8 Source: Tufts CSDD Approved NCE Database, 2000

  5. NCE Approvals in 2 or More Years, 1 Year or Less, and 6 Months or Less, 1990-1999 PDUFA 1 Year or Less 2 Years or More 6 Months or Less Source: Kaitin & DiMasi, Drug Inf J 2000;34:673-80

  6. Approval Phases for NCEs and Biopharmaceuticals Source: Tufts CSDD, 2000

  7. User Fee Review Phases for NCEs by FY Cohort Source: Tufts CSDD, 2000

  8. User Fee Review Phases for Biopharmaceuticals by FY Cohort Source: Tufts CSDD, 2000

  9. User Fee Review Phases for Standard and Priority NCEs, FYs 97-98 Source: Tufts CSDD, 2000

  10. Prior, Foreign Marketing of New Drugs Approved in the US, 1996-1998 Source: Kaitin & Healy, Drug Inf J 2000;34:1-14

  11. Prior, Foreign Marketing of New Drugs Approved in the US, 1991-1995 Source: Tufts CSDD Approved NCE Database, 1999

  12. New Drug Approvals and Withdrawals 1990-1999 * Withdrawals indicated by year of drug approval Source: Tufts CSDD, 2000

  13. Current Status of Pharmaceutical Innovation in the United States • Collegial FDA-sponsor relationship • Large number of NCE approvals • Faster approval times • Focus on development times • More drugs approved first in the U.S.

  14. Conclusions • PDUFA - most significant piece of drug legislation since 1962 Amendments • Overwhelming success in speeding drug review process and changing the relationship between agency and sponsors • Public ultimately benefits from faster access to important new drugs

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