[20181227]IF11058_药品短缺：原因、FDA授权和政策选择.pdf

https:/crsreports.congress.gov December 27, 2018Drug Shortages: Causes, FDA Authority, and Policy OptionsDrug shortages have remained a serious and persistent public health concern, despite the prevention and mitigation efforts of Congress, the Food and Drug Administration (FDA), and health care providers. While the number of new drug shortages has declined since its peak in 2011, many medically necessary products, such as sterile saline solution and sodium bicarbonate, remain in shortage. According to FDA, some active drug shortages have persisted for more than eight years. Figure 1. Number of New Drug Shortages, 2010-2017 Source: FDA annual reports on drug shortages for calendar years 2015, 2016, and 2017. Presentation from November 27, 2018, public meeting, “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions,” https:/healthpolicy.duke.edu/sites/default/files/atoms/files/duke-fda_drug_shortages_presentation_slides_0.pdf. Causes of drug shortages include manufacturing and quality issues (e.g., contaminants); lack of transparency (e.g., lack of information about drug quality and supply reliability); and business decisions made by individual firms (e.g., l