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  • Washington Highlights

    FDA Commissioner Issues a Statement on IV Fluid Shortages Following Hurricane Maria

    Jason Kleinman, Senior Legislative Analyst, Govt. Relations

    Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, issued a Nov. 17 statement to provide an update on the administration’s efforts to address the IV fluid shortage exacerbated by Hurricane Maria.

    Commissioner Gottlieb noted that the FDA is working closely with federal and Puerto Rican authorities to help stabilize the medical products manufacturing sector and is taking steps to mitigate product shortages, including IV fluids. In conjunction with manufacturers, the FDA is addressing this issue by:

    • Temporarily allowing the importation of IV saline products from facilities outside of the U.S.;
    • Encouraging the expansion of production at existing facilities to meet shortfalls; and
    • Expediting its review of new product applications that will help address this shortage.

    Gottlieb highlighted that “access to reliable power is integral to ensuring Puerto Rico-based medical product manufacturers return to full production capacity quickly.” He added, “As part of our efforts to reduce the risk of further shortages, the FDA has been working with federal and local government partners to prioritize a small number of critical facilities based on public health needs, including those plants that manufacture IV saline bags, for consideration or prioritization to gain earlier access to the electrical grid.”

    Additionally, the FDA is encouraging hospitals to consider clinical recommendations for managing shortages of IV fluids.