美国药品短缺及FDA采取的应对策略

U.S. drug shortage and the holistic countermeasures taken by FDA

根据FDA报告、美国国会报告和《2012年FDA安全与创新法案》分析归纳近年来美国出现的药品短缺及原因,以及药品监管机构采取的针对性措施和效果。药品短缺问题的解决不能诉诸于单一、简单的解决方案,而是需要监管机构、药品生产商、经销商、医疗保健服务提供商和其他利益攸关者的协作。

The causes for the drug shortage in the U. S. were analyzed based on the documents of the regu latory agency, congress reports and the 2012 FDA Safety and Innovation Act, along with the countermeasures taken by the regulatory agency and their effects. To address the drug shortage problem, one cannot resort to a single solu tion, but has to consider the coordination of the regulatory agency, pharmaceutical manufacturers, distributors, healthcare providers, and other stakeholders.