The New Drug Approvals of 1999, 2000, and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992

Abstract

This report is the sixth in a triennial series by the Tufts Center for the Study of Drug Development examining various aspects of recent new drug approvals in the United States. In 1999, 2000, and 2001 the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research approved 86 new drugs, 82 of which met the Tufts Center for the Study of Drug Development’s definition of a new chemical entity (NCE). Of the 82, 34 (41%) received priority review, while 48 (59%) had standard review. The mean length of the clinical phase (Investigational New Drug Application [IND] filing to New Drug Application [NDA] submission) for the 82 NCEs was 5.5 years, and the mean approval phase (NDA submission to approval) was 1.4 years. Whereas the clinical phase represents a 14% decrease from that value for the previous three-year period, the approval phase remained unchanged. The mean approval phase for priority NCEs (0.9 years) was half that for standard NCEs (1.8 years). Of the 75 NCEs for which foreign marketing data were available, 51 % were first approved for marketing in the United States, while 27% were available in foreign markets one or more years prior to United States approval, with a mean of 6.5 years of prior foreign marketing. The percentage of products first approved in the United States represents a continuation of a trend since passage of the Prescription Drug User Fee Act of 1992 of drug sponsors seeking marketing approval in the United States prior to approval in other markets.