Measuring the Pace of New Drug Development in the User Fee ERA

Abstract

The Prescription Drug User Fee Act of 1992 (PDUFA) is credited with the dramatic reduction in new drug approval times seen since 1993. Despite the faster approval times, however, the total time required for new drugs to reach the marketplace had not changed appreciably. With passage of the FDA Modernization Act of 1997 (FDAMA), the United States Food and Drug Administration (FDA) expanded its focus from shortening the regulatory review phase to helping drug developers reduce lengthy clinical development times and increase the speed to market for new products. Our analyses document a sharp downward trend in approval times during the 1990s—average approval time for new drugs fell 58%, from 31.3 months in the period 1990 to 1991 to 13.2 months in the period 1988 to 1999. Moreover, the percentage of new drugs approved in less than six months increased from 4% in 1992 to 28% in 1999. The data also show that, while average clinical development times increased by 14% from the period 1990 to 1991 to the period 1994 to 1995, there was a 37% decrease from the 1994 to 1995 period to the 1998 to 1999 period. The direction of change in average clinical development time from the first half of the 1990s to the second half varied by therapeutic class and by clinical development phase.