As Commissioner Gottlieb recently explained and we detailed last week in our 2017 annual report to Congress on drug shortages, the FDA does everything possible within our statutory authority to help address drug shortages. For example, using a range of available tools, the FDA’s Center for Drug Evaluation and Research worked with manufacturers to prevent 145 drug shortages in 2017. Still, there were 39 new shortages that occurred during 2017, and although this number is far lower than the peak of 251 new shortages in 2011, we recognize that many of these shortages have been for critical drug products and that they are having a tangible impact on patients.
IV fluid shortage
The 2017 hurricane season devastated Puerto Rico and impacted many of the drug and device manufacturers on the island. Among them was Baxter Healthcare Corporation. Baxter is a major manufacturer of sodium chloride-based (saline) and dextrose-based fluids for IV infusion, which, for example, are critical for mixing drugs for use in health care settings and are also used to keep patients hydrated. While IV fluids were in short supply before the hurricane and the FDA had been working with various manufacturers since 2014 to help improve the supply and address rising demand, the hurricanes compounded the pre-existing shortage situation leading to significant challenges in care across the country. After the hurricanes, the FDA quickly began working in partnership with Baxter and other manufacturers to consider ways to get ahead of the inevitable and significant impact on the existing shortage situation. With the support of other manufacturers, and after careful evaluation of the inspection history of specific manufacturing sites around the world, we worked with manufacturers to temporarily import IV fluids approved in other countries. We also expedited review of product applications from other manufacturers that would help with the shortage and add capacity to this market.
But even though the FDA quickly took these and other important steps, in the months following the hurricanes, many hospitals throughout the U.S. and abroad experienced serious shortfalls of these essential products. A particularly challenging flu season added to the concerns with IV fluid availability. The products’ scarcity forced health care professionals and facilities to use less desirable alternative therapies – for example, in some instances it required them to manually “push” drugs to patients through syringes instead of an IV drip, stretching already thin resources for medical staff at the bedside of patients.
After much work and a great deal of collaboration with a wide range of stakeholders, these IV fluid shortages are beginning to improve. Baxter is now producing at significantly higher levels. 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.