The imported drugs will be available at US children’s hospitals this week, FDA spokeswoman Lisa Kubaska, PharmD, told In-Pharmatechnologist.com. The FDA previously told us on May 10 that the imports would begin the week of May 14.
But this latest announcement on Wednesday will not mean that the shortage of TPN components will come to an end.
“The FDA is also working to find manufacturers able to supply other TPN components that are in shortage, including lipids, calcium and zinc,” Kubaska said. She previously told us that the FDA asked American Regent and Hospira to ramp up production of their zinc injections.
The FDA’s use of enforcement discretion to allow the TPN components is also temporary, though Kubaska told us that the imports will continue as long as necessary.
Matt Kuhn, senior director of communications and government affairs at Fresenius, told In-Pharmatechnologist.com that the Norwegian facility providing the TPN components -- Addamel, Glycophos and Peditrace -- is FDA-approved.
The agency reviewed a number of aspects of Fresenius’ processes and facilities, according to a blog post by Capt. Valerie Jensen, R.Ph., associate director of the drug shortages program at the FDA, including:
- The manufacturing practices at the manufacturing facilities, as well as at the facilities where the active pharmaceutical ingredients, or APIs, are produced;
- The history of inspections of those facilities from our own inspections or those of our regulatory counterparts; and
- The sterilization methods used for injectable drugs.
Since 2010, the FDA has used its regulatory discretion for the importation of 14 other drugs, including allowing Sun Pharma to import Lipodox (doxorubicin hydrochloride liposome injection) to deal with a critical shortage of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).
Shortage and US Manufacturers
The TPN shortages are largely caused by the decision of American Regent and Luitpold Pharmaceuticals to close down one of its manufacturing sites in 2012 due to quality issues. The company found particulates in its phosphate injections, according to an April letter to healthcare professionals.
The FDA requested that the company not close down the site because of the medically necessary products that they make there, Kubaska told us previously.
But American Regent closed the site and other manufacturers of TPN components, including Hospira, are still working to increase supplies of these critical drugs.
While the FDA cannot force a manufacturer to make a product, the agency said it “will continue to provide expedited regulatory review and advice to manufacturers of TPN components and other drugs most in need.”