FDA issues update on efforts to address IV fluid shortages
Food and Drug Administration Commissioner Scott Gottlieb, M.D., today reviewed actions the agency is taking to address the increased shortages of sodium chloride injection bags and other saline intravenous fluids used in hospital and outpatient settings since Hurricane Maria impacted production facilities in Puerto Rico. The actions include efforts to temporarily import products from other countries, expand production at existing facilities, expedite review of new product applications, and encourage the island to prioritize access to the electrical grid for critical facilities. Gottlieb also encouraged health care providers to consider recent guidance from the American Society of Health-System Pharmacists and others for managing the shortages and discouraged product hoarding. AHA and others have urged FDA and Congress to quickly resolve the shortages and develop a comprehensive strategy to manage such situations moving forward. In other news, the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response has launched a webpage highlighting its resources to help stakeholders prepare for and manage drug shortages and allocate scarce resources.