The FDA, trying to help face down a national shortage of saline in the U.S., is for the second time allowing a manufacturer to import product from a plant in Europe that is not approved for the U.S. market. Having already approved Fresenius Kabi to bring in saline from a plant in Norway, the agency is now permitting Baxter International to ship from a plant in Spain.
The agency said Monday that the "FDA is temporarily exercising its discretion regarding the distribution of Baxter's saline product from Spain and Fresenius Kabi's saline product from Norway as needed to address this critical shortage, which poses a serious threat to patients."
It said it had inspected Baxter's ($BAX) plant in Spain to ensure that it hits FDA standards. In March, the agency gave temporary approval to German drugmaker Fresenius Kabi to ship some of its Norwegian-made product to the U.S. after making sure it met FDA standards.
For months now, there has been a severe shortage of saline, forcing many U.S. hospitals to rethink their use to make sure they can maintain supplies of the common but essential treatment.
The FDA has also been working with the three U.S. manufacturers, Baxter, Hospira ($HSP) and B. Braun Medical, to boost their U.S. production. "We are producing at maximum capacity to meet patient and customer needs. We increased production 3% in 2013 year over year, and are investing to increase production another 9% in 2014," a Baxter spokesperson said recently.
Despite all of these efforts, the shortage will persist. "While the shipments described above will help reduce current disruptions, they will not resolve the current shortage of 0.9% sodium chloride injection," the agency conceded in its update.
- here's the FDA announcement