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10/27/2017

Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico

Since Hurricanes Irma and Maria devastated the island of Puerto Rico, the FDA has been working closely with Baxter and other companies to reduce the risk of shortages of critically important drugs and to minimize impact on any existing shortages. In particular, Baxter and the FDA have closely monitored and identified ways to prevent a significant shortfall of production of Baxter’s sodium chloride 0.9% injection bags from its Puerto Rico facility. Also known as mini bags, this product is used to provide fluids and medicines to patients across the U.S. While these products have been in shortage industry wide since 2014 and other manufacturers exist, the agency and Baxter recognized that further shortage of this product could potentially put U.S healthcare at risk. The FDA has worked closely with Baxter to find solutions to prevent additional shortages.

Among the FDA’s efforts to assist Baxter, the agency recently helped facilitate the import of these products from the firm’s facilities in Ireland and Australia after the company lost several production days at its Puerto Rico facilities. The FDA has also taken many steps to help Baxter restore operations in its Puerto Rico facilities and move critical products onto and off the island. The FDA and Baxter will continue to keep in close consultation as we monitor the challenging situation on the island. The agency is also continuing its work with other manufacturers on steps to prevent or mitigate shortages of other types of critical medical products. Among the actions that the FDA is taking — in conjunction with other manufacturers and federal and local government partners — to help restore production in Puerto Rico and maintain operations on the island is helping facilities secure fuel and manufacturing supplies, and the logistical support to move critical products onto and off the island. The FDA is also expediting reviews and approvals of other dosage forms and generic versions of products as alternate sources of critical products. Above all else, we at the FDA remain fully committed — for the long run — to the people of Puerto Rico to help them recover from this tragedy.