After two years featuring a steady stream of recalls, it may have come as no surprise to many when American Regent temporarily closed its doors at the end of 2012. Unsurprising, too, was the drug shortage that followed: a dearth of injectable drugs used in total parenteral nutrition (TPN). The FDA announced Wednesday that it had a plan in place, assuring that imports would be arriving and available to patients this week.
In the announcement, the FDA said it was exercising regulatory discretion for the U.S. division of Fresenius Kabi to import trace elements and phosphate injection for TPN from its Norway plant. TPN, an intravenous food solution, is most commonly used by infants, but the shortage has also affected adult cancer and surgery patients who are unable to eat or drink by mouth.
"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," Valerie Jensen, associate director of the Drug Shortage Program in the FDA's Center for Drug Evaluation and Research, said in a statement. "We believe the import of these injectable nutrition drugs is going to meet current supply needs over the coming weeks."
American Regent, a division of Luitpold Pharmaceuticals owned by Daiichi Sankyo, first faced challenges in 2010, when it was forced to make two product recalls for sodium bicarbonate vials containing particles. And the problems persisted; by 2012, the company had issued recalls related to glass chips and, later, silicon particles as well. The FDA said it began looking for ways to increase TPN supply upon learning of American Regent's shutdown, as the company is a large producer. But Fresenius Kabi USA is not totally in the clear, either. The company has had its own issues with particle contamination. On Wednesday, Fresenius alerted regulators of a recall of one lot of its Magnesium Sulfate Injection due to the presence of glass, according to the FDA.
This is not the first time this year the FDA has relied on imports to combat a drug shortage. For nearly a year, the FDA had been allowing Sun Pharma to import an unapproved version of generic Doxil to ease a shortage of the Johnson & Johnson ($JNJ) cancer drug before it fast-tracked approval of the Sun version this February. "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," FDA Commissioner Margaret Hamburg said. "The FDA is doing all it can, using every tool we have to resolve and prevent drug shortages."
Special Report: Daiichi Sankyo/Luitpold Pharmaceuticals/American Regent - Fierce's 2011 warning letters report
Editor's note: This story has been updated with information on Fresenius Kabi USA's Magnesium Sulfate Injection recall.