Pharmaceutical policy change and the safety of new drugs
Pharmaceutical policy change and the safety of new drugs
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DOI：
10.1086/368006
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发表时间：
2002-10-01
影响因子：
2.2
通讯作者：
Olson, MK
中科院分区：
文献类型：
--
作者：
Olson, MK
美国食品和药物管理局（FDA）的政策改革大大提高了新药审查的速度。虽然数据显示FDA对新药的审查时间减少了50%，但其他数据显示，由于安全原因，一些新药已经退出市场。这一连串的新药停药引发了一个问题。新药审评速度的提高是否对新药安全性产生了不利影响？本分析使用来自FDA自发报告系统的药物不良反应（ADR）数据来检查这个问题。具体来说，新批准药物的不良反应计数是使用负二项回归分析作为药物特征、患者特征和监管因素（如新药审评速度）的函数来估计的。主要结果是新药审查时间的减少与需要住院治疗的不良反应和导致死亡的不良反应的增加有关。
Policy reforms in the Food and Drug Administration (FDA) have led to substantial increases in the speed of new-drug review. While data show that FDA review times for new drugs have fallen as much as 50 percent, other data show that several new drugs have been withdrawn from the market for safety reasons. This flurry of new-drug withdrawals raises a question. Have increases in the speed of new-drug review had an adverse effect on new-drug safety? This analysis uses adverse drug reaction (ADR) data from the FDA's Spontaneous Reporting System to examine this question. Specifically, ADR counts for newly approved drugs are estimated as a function of drug characteristics, patient characteristics, and regulatory factors (such as the speed of new-drug review) using negative binomial regression analysis. The primary result is that reductions in new-drug review times are associated with increases in both ADRs requiring hospitalization and ADRs resulting in death.