FDA has announced the import of injectable drugs used in total parenteral nutrition (TPN), which have been in critical shortage. FDA is exercising regulatory discretion by allowing Fresenius Kabi USA based in Lake Zurich, IL, to import trace elements and phosphate injection from its Norway plant. Other manufacturers of TPN components, including Hospira of Lake Forest, IL, are also working to increase supplies of these critical drugs.
“TPN component shortages have been a high priority for the agency. Since the onset of these shortages, the FDA has been very concerned about the dwindling supply of injectable nutrition products and the effect this is having on children’s hospitals treating vulnerable patients,” said Valerie Jensen, R.Ph., associate director of the drug shortages program in the FDA’s Center for Drug Evaluation and Research, in a FDA press release. “We believe the import of these injectable nutrition drugs is going to meet current supply needs over the coming weeks.”
"While we have made progress on the critical issue of drug shortages, we remain extremely concerned about all current and potential drug shortages, and we are vigilant in our efforts so patients have access to the medicines they need, when they need them,” said FDA Commissioner Margaret A. Hamburg, M.D., in the release. "The FDA is doing all it can, using every tool we have to resolve and prevent drug shortages."
TPN is an intravenous food solution containing several drugs that have been in short supply, including trace elements, potassium phosphate, and sodium phosphate. Hospitals nationwide rely on TPN, which is primarily used to treat premature infants who are unable to eat or drink by mouth or who are experiencing other deficiencies. Cancer patients and those who have had gastrointestinal surgeries who are also unable to eat or drink by mouth have been affected by these shortages.
The shortages are largely the result of a decision by American Regent/Luitpold, a large manufacturer of TPN products, to temporarily shut down at the end of 2012. While FDA worked with American Regent in an effort to avoid a shutdown, the company decided that it had to cease operations temporarily to address quality issues that included particulate matter in its injectable products. FDA continues to work with the company to prioritize the most critical drugs in shortage as it restarts production and, on the quality issues, to protect patient health.
FDA, upon learning of American Regent’s decision to temporarily shut down, looked for ways to increase supply and ultimately sought foreign companies willing and able to help resolve the shortage. FDA states in the press release that the agency evaluates foreign drugs to ensure that the drugs are of adequate quality and doe not pose undue risks for US patients.