FDA, Baxter issue update on manufacturing recovery in Puerto Rico

The Food and Drug Administration and Baxter provided an update on efforts Baxter and other companies have taken to reduce the risk of shortages of critically important drugs and to minimize impact on any existing shortages in Puerto Rico after Hurricanes Irma and Maria. 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. “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,” FDA Commissioner Scott Gottlieb, M.D. said in a statement. “The FDA is also expediting reviews and approvals of other dosage forms and generic versions of products as alternate sources of critical products.” The FDA last week said it is permitting the temporary importation of Baxter products from its plants in Ireland and Australia.