GAO issues update on drug shortages

The number of new drug shortages has generally decreased since 2011, while the number of ongoing shortages remains high, according to a new report by the Government Accountability Office. The report, mandated by the FDA Safety and Innovation Act of 2012, examines 2010-2015 data on drug shortages from the University of Utah Drug Information Service; Food and Drug Administration efforts to prioritize reviews of drug submissions to address shortages; trends in FDA warning letters issued to sterile injectable manufacturing establishments for noncompliance with manufacturing standards; and certain factors that may affect shortages of sterile injectable drugs, such as a decline in the number of suppliers, FDA warning letters and relatively low profit margins for generic drugs. According to the report, there were 136 new drug shortages in 2015, down from 257 in 2011, while the number of ongoing drug shortages increased to 291 from 184 over the period.