Shulman S R, Kaitin K I
Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts, USA.
Pharmacoeconomics. 1996 Feb;9(2):121-33. doi: 10.2165/00019053-199609020-00004.
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.
1992年的《处方药使用者付费法案》授权美国食品药品监督管理局（FDA）在5年时间内收取超过3.32亿美元的使用者费用收入。国会不仅决定将这笔收入专门用于加快FDA对人类药物申请的审查，FDA还明确了到1997财年要实现的严格的特定时间绩效目标。在这个5年计划的中期，FDA报告称它已经达到或超过了其绩效目标。在本文中，我们回顾了美国使用者付费计划的历史，概述了立法条款的细节，并讨论了该机构在努力同时实现使用者付费目标以及应对要求FDA进行实质性改革的政治力量时所面临的挑战。随着经济压力迫使一些国家考虑将部分监管审查成本转嫁给受监管行业，使用者费用对全球制药和生物技术行业来说变得越来越重要。本文提供了关于美国框架的参考，随着使用者付费现象的蔓延，可能对未来的国际比较有用。
