Drug shortages are an ongoing U.S. public health crisis. New annually reported incidents grew dramatically from 117 in 2007 to a high of 255 in 2011.1 Although such reports have begun to decline, unresolved drug shortages persist. In 2012, the United States experienced 456 active drug shortages, many of them crucial medicines used in cancer treatment, surgery, and intensive care.2
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) strengthened FDA's ability to respond to and resolve drug shortages by requiring manufacturers to report supply interruptions for medically necessary drugs to the agency. The law also allows FDA to help manufacturers adjust their production in response to a shortage by expediting the necessary review.
Although these changes have improved gaps in supply, high numbers of ongoing drug shortages still continue to affect the ability of patients to access essential medications. Because such shortages are typically the result of complex and related factors, more research is needed to identify effective solutions.
- U.S. Government Accountability Office, “Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability” (February 2014, Publication No. GAO-14-194), http://www.gao.gov/assets/670/660785.pdf.