FDA Announces Import of Injectable Nutrition Drugs
Action addresses shortages of drugs needed to treat premature infants, patients unable to eat or drink by mouth
The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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.
"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. "The FDA is doing all it can, using every tool we have to resolve and prevent drug shortages."
The FDA is exercising regulatory discretion for Fresenius Kabi USA, LLC, based in Lake Zurich, Ill., to import trace elements and phosphate injection from its Norway plant so the drugs can reach Americans in need.
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. The FDA worked with American Regent in an effort to avoid a shutdown. The company, however, ultimately decided that it had to cease operations temporarily in order to address quality issues that included particulate matter in its injectable products. The 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.
Upon learning of American Regent’s decision to temporarily shut down, the FDA looked for ways to increase supply and ultimately sought foreign companies willing and able to help the United States resolve these shortages. When the FDA looks for a foreign source to bolster supply in the U.S., the agency evaluates the foreign drug to ensure that it is of adequate quality and does not pose undue risks for U.S. patients.
'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. 'We believe the import of these injectable nutrition drugs is going to meet current supply needs over the coming weeks.'
The FDA’s exercise of enforcement discretion for these TPN components is temporary, and applied to address this critical shortage. While the FDA cannot force a manufacturer to make a product, the agency will continue to provide expedited regulatory review and advice to manufacturers of TPN components and other drugs most in need.
Other manufacturers of TPN components, including Hospira, Inc. of Lake Forest, Ill., are also working to increase supplies of these critical drugs.
Since 2010, the FDA has used its regulatory discretion for the importation of 14 drugs. With the addition of these injectable nutrition drugs, the total will be at 17.
May 29, 2013
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