FDA update on some ongoing shortages related to I.V. fluids

FDA Commissioner Scott Gottlieb, MD, said Tuesday that he expects the shortage of I.V. saline fluids stemming from the effects of Hurricane Maria in Puerto Rico to improve in the coming weeks and months. "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," he said. FDA is also looking at additional potential import sites for small and larger volume I.V. saline bags, and its approval of I.V. saline products from Fresenius Kabi and Laboratorios Grifols should help boost product supply in the U.S. market in the next several weeks. Gottlieb said FDA is also asking companies to submit data to extend expiration dates for these products. Additionally, he noted the agency is paying close attention to demand for empty I.V. containers as an alternative to filled bags. "We understand that, with the shortage of filled bags, hospitals and other health care providers are turning to the repackaging or compounding of I.V. saline fluids and utilizing empty I.V. containers," he said. "This is resulting in diminished supplies of these containers and concerns that supplies of empty bags could tighten further."