Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2013 Feb;93(2):170-6. doi: 10.1038/clpt.2012.220. Epub 2012 Nov 7.
Over the past few years, an increasing number of critically needed medicines have been in short supply. Using economic theory to frame the drug-shortage problem, this paper explores why and how manufacturing-quality problems could combine with other economic and technological factors to result in shortages of generic sterile injectable drugs. The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments. The US Food and Drug Administration's (FDA's) need to use its regulatory flexibility, on behalf of patients, to avoid shortages of medically necessary drugs may further strengthen the incentive to "push the envelope" on quality. These dynamics may have produced a market situation in which quality problems have become sufficiently common and severe to result in drug shortages.
在过去的几年中,越来越多的急需药品出现短缺。本文运用经济学理论来构建药品短缺问题,探讨了为什么以及如何出现制造质量问题,以及这些问题如何与其他经济和技术因素结合起来导致普通无菌注射类药品短缺。我们发现的根本问题是市场无法观察和奖励质量。这种缺乏质量奖励的情况会加剧价格竞争,并鼓励制造商通过最小化质量投资来降低成本。美国食品和药物管理局(FDA)代表患者行使监管灵活性,以避免医疗必需药物短缺,这可能会进一步加强对质量“推陈出新”的激励。这些动态可能导致市场出现质量问题变得普遍且严重,从而导致药品短缺。