FDA lets Fresenius import saline to help with shortage

The FDA has been scrambling for months to help relieve shortages of some common products used in U.S. hospitals, including saline solution and nitroglycerin. To do that it has been looking for some overseas suppliers that can kick in extra capacity, and it now says it has found one to get more saline into the U.S.

The agency said Friday that it will temporarily allow German drugmaker Fresenius Kabi to bring in saline solution made at a plant in Norway that is not currently approved to ship the product to the U.S. The FDA said it has given the facility a thorough going-over to make sure it meets its standards. Healthcare providers were told to contact Fresenius if they are in need of more product. While this will help, the FDA acknowledged it "will not resolve the shortage," and so it continues to work with the three U.S. producers--Baxter International ($BAX), B.Braun Medical and Hospira ($HSP)--to boost production.

Saline is one of those products that hospitals turn to millions of times a week, but for months they have had to think twice about how they use their limited supplies. Baxter has been working to ramp up production to help, but in January it put noncontract buyers on an allocations system because supplies were so tight. The situation was exacerbated in December when Baxter had to recall four lots of saline because particulate was found in some containers.

This is not the first time the FDA has made concessions to overseas manufacturers to deal with a shortage. In 2012, it allowed Sun Pharmaceuticals to temporarily sell an unapproved generic version of Johnson & Johnson's ($JNJ) cancer drug Doxil in the U.S., then worked with the Indian drugmaker to get its product to meet all of the U.S. requirements.

The FDA is also working with an as-yet-to-be-identified overseas producer of the heart drug nitroglycerin, another hospital staple in short supply. Capt. Valerie Jensen, associate director of the FDA's drug shortage program, told The New York Times last week that the FDA has found an overseas supplier that can provide some product "in coming weeks." Baxter became the sole U.S. supplier of the drug last year when manufacturing problems sidelined production from Hospira and American Regent, but it has had trouble keeping up with demand. Baxter spokeswoman Deborah Spak told the newspaper that the company is ramping up production of the drug and was "hopeful that overall demand and supply will resume to a more predictable state within the next few months."

- read the FDA announcement

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