FDA Issues Update on Actions to Address Drug Shortages

Shortages of intravenous saline and other fluids are beginning to improve, according to the Food and Drug Administration. “Baxter is now producing at significantly higher levels,” said Douglas Throckmorton, M.D., deputy director for regulatory programs at FDA’s Center for Drug Evaluation and Research. “Other companies, including ICU Medical, B. Braun Medical, Laboratorios Grifols and Fresenius Kabi, are also producing critically-needed saline, many of which received expedited FDA reviews of their applications and supplements to add capacity and additional supply. In addition, six different manufacturing sites continue to temporarily import saline, which is helping to meet patient needs until the shortage completely resolves and approved IV fluid products can meet all demand.” FDA also is working with companies to address shortages of injectable opioid pain medications, he said. “While Pfizer currently expects that delays will continue until 2019, we are working with them to increase supplies before then. We are also working with other companies that manufacture FDA-approved injectable analgesics, which have agreed to increase their production, including Akorn Pharmaceuticals, Fresenius Kabi USA and West-Ward Pharmaceuticals. However, it is taking time for these companies to produce enough product to cover the shortfall in the market. We will continue to share updates on our website as this situation progresses.” FDA also has redesigned its drug shortages web page in an effort to make it easier to access information on current drug shortages.