FDA Commissioner Provides Update on IV Fluid Shortages in Puerto Rico
The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued an update on IV fluid shortages in Puerto Rico following Hurricanes Irma and Maria. This follows a January 2018 update regarding IV saline shortages.
“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.”
The FDA says it is also looking at additional potential import sites for both small and larger volume IV saline bags. Further, its approval of IV saline products from additional companies, specifically Fresenius Kabi and Laboratorios Grifols, is expected to result in increasing product supply in the US market in the next several weeks. In addition to these steps, the FDA is asking companies to submit data to extend expiration dates for these products.
Gottlieb also says the FDA is monitoring the impact of the mitigation strategies being employed by health care providers as a result of the shortage of IV saline fluids.
“One area that we’re paying particularly close attention to is the demand for empty IV containers as an alternative to filled bags,” Gottlieb said in a January 16, 2018 statement. “The empty containers are regulated by the FDA as Class II medical devices. They are manufactured by some of the same companies as the filled bags as well as other medical supply manufacturers. We understand that, with the shortage of filled bags, hospitals and other healthcare providers are turning to the repackaging or compounding of IV saline fluids and utilizing empty IV containers. This is resulting in diminished supplies of these containers and concerns that supplies of empty bags could tighten further.”
The FDA says it is assessing existing product supply, demand trends, and the capacity of manufacturers of these bags to ramp up their production. The agency believes the demand for empty containers will recalibrate as the supply of filled bags increases. However, in the meantime, the FDA plans to see what steps it can take to ensure that shortages of these empty containers do not occur.
Gottlieb says the FDA will continue to pursue efforts to increase supplies of IV saline as well as monitor the impact of mitigation strategies on the supply chain.