The Prescription Drug User Fee Act of 1992. A 5-year experiment for industry and the FDA.
The Prescription Drug User Fee Act of 1992 authorises the US Food and Drug Administration (FDA) to collect in excess of $US332 million in user fee revenues over a 5-year period. Not only did Congress determine that the revenues would be dedicated to expediting the FDA's review of human drug applications, the FDA articulated formidable time-specific performance goals to be achieved by fiscal year 1997. At the mid-point in the 5-year programme, the FDA reported that it had met or exceeded its performance goals. In this article, we review the history of the user fee scheme in the US, outline the details of the legislative provisions, and discuss the challenges confronting the agency as it works to simultaneously meet the user fee goals and respond to political forces calling for substantive FDA reform. User fees loom large for the global pharmaceutical and biotechnology industries as economic pressures force a number of countries to consider shifting a portion of the cost of regulatory review to the regulated industry. This article provides a reference on the US framework and may be useful in future international comparisons as the user fee phenomenon spreads.
Shulman
S R
SR
Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts, USA.
Kaitin
K I
KI
D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence*; D011307:Drug Prescriptions / Q000191:economics*; D006801:Humans; D007880:Legislation, Drug; D014481:United States; D014486:United States Food and Drug Administration