IV saline and other drug shortages are FDA priority, agency tells AHA
AHA News Now
Apr 21, 2014
The Food and Drug Administration does not have the authority to require a manufacturer to make a product or direct a manufacturer’s business decisions about manufacturing capacity, but “will take every action within its authority to help alleviate the shortage of IV saline and other drugs and increase supplies in the marketplace,” FDA Commissioner Margaret Hamburg, M.D., told AHA today. “Please be assured that the prevention and mitigation of drug shortages is a key priority for FDA,” Hamburg said in a letter to AHA Executive Vice President Rick Pollack. She said the agency “will continue to work with manufacturers, providers, patients, patient advocates, and other stakeholders to protect patients and identify solutions to this serious problem.” Pollack last month urged the agency to vigorously pursue additional supplies and suppliers of normal saline and other intravenous fluids that are fundamental to patient care in hospitals, to ease the severe, long-standing shortage of these products and prevent future shortages. For IV fluid conservation strategies, see the AHA’s March 20 Quality Advisory for members.