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  • Washington Highlights

    FDA Commissioner Gottlieb Comments on Ongoing IV Saline Shortages

    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel

    Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, Jan. 16 issued a statement updating the public about ongoing IV saline shortages and the FDA’s efforts to mitigate the shortages. The shortage has been exacerbated by Hurricane Maria in Puerto Rico, where the facilities of two of the larger manufacturers of IV saline, Baxter and B. Braun, were severely impacted by the storm.

    In his statement, Commissioner Gottlieb notes that the FDA has been working with Baxter and B. Braun to import IV saline from their foreign facilities. Additionally, the FDA has approved IV saline product from two new companies, Frenisius Kabi and Laboratorios Grifols, which likely will help address the shortage. The FDA is also working with companies to determine if expiration dates for these products can be safely extended.

    While the FDA continues its efforts to resolve the shortage, the impact and severity of this year’s flu season will likely hamper FDA efforts and further constrain IV saline supply. The AAMC has been routinely interacting with the FDA on the IV shortage issue and has been providing ongoing feedback from our members directly to the Drug Shortage staff at FDA. The FDA maintains a drug shortage website with all relevant and pertinent information about the IV saline shortage.