The New Drug Approvals of 1996, 1997, and 1998: Drug Development Trends in the User Fee Era
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0092-8615/2000 Copyright 0 2000 Drug Information Association Inc.
THE NEW DRUG APPROVALS OF 1996, 1997, AND 1998: DRUG DEVELOPMENT TRENDS IN THE USER FEE ERA* KENNETHI. KAITIN,PHD Director
ELAINEM. HEALY,BA Research Coordinator Tufts Center for the Study of Drug Development Tufts University, Boston, Massachusetts
This is the fifth in a series of triennial reports by the Tufts Center for the Study of Drug Development (CSDD) examining various aspects of recent new drug approvals in the United States. In 1996, 1997, and I998 the United States Food and Drug Administration (FDA) approved 122 new drugs, 110 of which met Tufts CSDDk definition of a new chemical entity (NCE). Of the 110, 38 (35%) received priority review, while 72 (65%) had standard review. The mean length of the clinical phase (investigational new drug application [IND]filing to new drug application [NDA] submission) was 70.3 months (ie, 5.9 years), and the approval phase (NDA submission to approval) was 16.8 months (1.4 years). Both the clinical and approval phases represent decreases from those values for the previous three-year period (19% and 31%. respectively). The decrease in the clinical phase for the 1996 to 1998 NCEs represents the first such decline since the mid1980s. The mean approval phase for priority NCEs (11.8 months) was 38% shorter than that for standard NCEs (19.5 months). Of the 107 NCEs for which foreign marketing data were available, 49% were first approved for marketing in the United States, while 26% were available in foreign markets one or more years prior to United States approval, with a mean of 5.7 years of prior foreign marketing. The percent of products first available in the United States represents a considerable increase over that number for previous years. Key Words:New chemical entity; Drug development; Pharmaceutical innovation; Pharmaceutical industry; Food and Drug Administration; Prescription Drug User Fee Act of 1992; FDA Modernization Act of 1997
*Preliminary results were presented at the 35* DIA Annual Meeting, June 27-July 1, 1999, Baltimore, Maryland, and at the American Society for Clinical Pharmacology and Therapeutics 100' Annual Meeting (poster session), San Antonio, Texas,March 18-20. 1999. Reprint address: Kenneth I. Kaitin, Ph.D., Director, Tufts Center for the Study of Drug Development, 192 South St., Suite 550, Boston, MA 021 11. E-mail: [email protected].
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Kenneth I. Kaitin and Elaine M . Healy
INTRODUCTION OVER THE PAST 15 YEARS, the Tufts Center for the Study of Drug Development has published a series of triennial reports, referred to as the trends in drug development series (1-4), that examine various aspects of new drugs approved by the Food and Drug Administration. The current report is the fifth in this series, focusing on the new drug approvals of 1996, 1997, and 1998. Data from the current three-year period are analyzed and compared with Tufts CSDD data from previous years to examine recent trends
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