FDA issues update on IV saline supplies

FDA Commissioner Scott Gottlieb, M.D., today issued an update on the agency’s efforts to address ongoing shortages of intravenous saline. “Based on the information we’re receiving from companies and the actions we’ve taken at FDA, we continue to expect that the shortage of IV fluids will improve in the coming weeks and months,” Gottlieb said. “In addition to working with manufacturers to ensure that their Puerto Rico facilities can operate at full capacity, we’ve worked with manufacturers such as Baxter and B. Braun to import product into the U.S. from their foreign facilities including most recently from a Baxter facility in Brazil. We are also looking at additional potential import sites for both small and larger volume IV saline bags. Further, our approval of IV saline products from additional companies, specifically Fresenius Kabi and Laboratorios Grifols, is expected to result in increasing product supply in U.S. market in the next several weeks.” FDA also is working with companies to see if expiration dates for shortage products can be safely extended, and is assessing supply and demand for empty IV bags and the capacity of manufacturers of these bags to ramp up their production, he said.