The PDUFA report

WASHINGTON - The FDA last week provided to Congress its fourth annual performance report on the Prescription Drug User Fee Act of 1992 (PDUFA), and FDA Commissioner David Kessler boasted of the progress the report reflects in a valedictory address to the Food and Drug Law Institute.

In what the agency said was Kessler's last major speech as commissioner, he said the most important measure of the agency's improvement is the number of new molecular entities (NMEs) approved: 46 in fiscal year 1996 compared to an average of 25.6 in the 1990-95 period, 21.7 in the 1980s, and 17.3 in the 1970s.