The U.S. Food and Drug Administration (FDA) recently issued a statement regarding the agency's response to ongoing shortages of medically necessary products, including intravenous (IV) saline.

According to Douglas Throckmorton, MD, deputy center director for regulatory programs in FDA's Center for Drug Evaluation and Research, after much work and a great deal of collaboration with a wide range of stakeholders, IV fluid shortages are beginning to improve.

While the shortage of IV fluids existed prior to Hurricane Maria, the 2017 hurricane season that devastated Puerto Rico further impaired many of the drug and device manufacturers with operations on the island. The FDA worked with manufacturers, including Baxter Healthcare Corporations and B. Braun, to allow Puerto Rican facilities to fully operate and improve the supply. Despite these steps, hospitals in the U.S. and abroad still experience critical shortages, exacerbated by a tumultuous flu season.

To address the demand, the agency temporarily imported IV fluids approved in other countries and expedited the review of product applications that would extend market capacity. Six manufacturing sites continue to temporarily import saline, helping to meet patient needs until the shortage completely resolves.

The FDA continues to closely monitor product supply shortages and will issue additional updates as needed.

Keywords: ACC Advocacy, Drug Evaluation, Puerto Rico, United States Food and Drug Administration, Research, Pharmaceutical Preparations, Hispanic Americans

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