The FDA has just announced that it will allow emergency imports of injectable drugs used in total parenteral nutrition (TPN), due to a serious shortage throughout the USA.
TPN is for patients who cannot get their nutrition by eating. It involves using a drip with a needle or catheter placed in the vein containing food solution as well as several drugs, such as trace elements, potassium phosphate, and sodium phosphate.
The current shortage is affecting the many premature infants who can’t eat or drink by mouth, as well as cancer patients who have experienced gastrointestinal surgeries and can’t eat normally.
The FDA Commissioner Margaret A. Hamburg, M.D., said:
“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.The FDA is doing all it can, using every tool we have to resolve and prevent drug shortages.”
The FDA is allowing emergency imports of important components of total parenteral nutrition (TPN) products by Fresenius Kabi USA, LLC, based in Lake Zurich, Illinois, from a plant it has in Norway.
This decision will help the TPN drugs reach the many Americans in need.
A typical bag of TPN products
The current shortage of injectable nutrition drugs is the result of manufacturing problems at a large maker of TPN products called “American Regent/Luitpold”. The firm temporarily shut down at the end of 2012.
The FDA tried to intervene to keep the company going. However, in the end American Regent decided to halt manufacturing operations to assess quality issues with its injectable products.
The agency will continue to work with the company to try and prioritize the most critical drugs that are in short supply as it restarts production.
When the company shut down, the FDA was forced to desperately find ways to make up for the shortage which many describe as an emergency. Ultimately they sought out foreign companies which might be able to meet the current supply needs. The products were evaluated to make sure they were up to standard and did not pose any health risks for American patients.
Valerie Jensen, R.Ph., associate director of the drug shortages program in the FDA’s Center for Drug Evaluation and Research, said:
“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. We believe the import of these injectable nutrition drugs is going to meet current supply needs over the coming weeks.”
The agency’s temporary enforcement discretion for these TPN components is only to meet the needs of patients during the current shortage.
Even though the agency cannot force a company into producing a product, it can provide expedited regulatory review to speed up the process. Hospira, Inc. of Lake Forest, Ill. is another manufacturer currently working to increase supplies of TPNs.
Since 2010, a total of 17 drugs have been imported under the FDA’s regulatory discretion.
Written by Joseph Nordqvist