GAO reports on PDUFA

The rate of withdrawals of new drugs for safety reasons increased after enactment of the Prescription Drug User Fee Act, according to a General Accounting Office report. The report, which was delivered to Congress Sept. 17, concludes that "the percentage of recently approved drugs that have been withdrawn from the market has risen, but that the size of the increase in drug withdrawal rates differs depending on the period examined."

FDA charged, however, that the increase only is seen if a specific four-year period is examined and that the statistics are skewed because of the low number of events involved. The withdrawal rate declined from 2% during 1989-1992 (the four years preceding PDUFA) to 1.6% during 1993-1996 under PDUFA I. The rate rose to 5.3% from 1997-2000 under PDUFA II. ...