FDA Recognizes Fresenius Kabi with Drug Shortage Assistance Award
The FDA recognized the role Fresenius Kabi played in helping mitigate a shortage of IV saline, specifically sodium chloride injection USP, 0.9% in bags.
Officials with Fresenius Kabi, who recently were granted approval for a US distribution center to be built in the Pleasant Prairie, Wisconsin area, according to local news reports and have been tackling the ongoing issue of drug shortages head on, have been recently recognized by the FDA with a Drug Shortage Assistance Award.
In December of 2018, the FDA recognized the role Fresenius Kabi played in helping mitigate a shortage of IV saline, specifically sodium chloride injection USP, 0.9% in bags. The shortage was caused last year by supply disruptions at manufacturers affected by Hurricane Maria. The hurricane devastated Puerto Rico, where many companies produce medicines for US hospitals.
Through the Drug Shortage Assistance Award program, the FDA recognizes companies for making a substantial contribution to preventing or alleviating a critical drug shortage. The award also recognizes companies for their commitment to public health and quality manufacturing.
Working with drug manufacturers, the FDA helped prevent 132 drug shortages in 2017 and 115 in 2016. There were 35 new drug shortages in 2017 and 23 new shortages in 2016. Although there was a slight increase in shortages in 2017 compared to 2016, this is still lower than previous years. Two key prevention strategies have helped drive this decrease in new shortages: 1) early notification and 2) a focus on high-quality manufacturing. The FDA is committed to working with companies, like Fresenius Kabi, to prevent and mitigate drug shortages.
“Fresenius Kabi is pleased to work with the FDA to help prevent and mitigate shortages,” said John Ducker, president and CEO of Fresenius Kabi USA. “Our collaboration with the FDA is focused on helping clinicians and hospitals assure patients in the US have access to the medicines they need. This recognition is a great compliment to the many Fresenius Kabi employees in various roles across our company who are needed to respond to the shortages which, unfortunately, continue to be an issue in the United States.”
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company is a leading developer, manufacturer and provider of injected and infused medicines in the United States and has worked closely with the FDA Center for Drug Evaluation and Research’s Office of Drug Shortages on multiple drug shortages.
Fresenius Kabi Receives FDA Drug Shortage Assistance Award [news release]. FDA website. Published Dec. 3, 2018. Accessed at: https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM624374.pdf