The FDA continues to grapple with shortages of saline intravenous injection bags that were worsened when Hurricane Maria devastated Puerto Rico, and the agency is temporarily allowing the importation of bags to boost the supply, Commissioner Scott Gottlieb said.
Shortages of the bags have been reported intermittently since 2014, but the hurricane exacerbated them significantly when it struck Puerto Rican manufacturers, he said. The FDA has been working with Baxter, owner of a storm-damaged bag factory in Puerto Rico, to restore its production.
The FDA recently has approved saline bags for import from Fresenius Kabi, a German producer, and from Grifols, headquartered in Spain, Gottlieb said.
The agency also is working with federal and local officials to move medical-products factories to the head of the line for regaining access to the damaged Puerto Rican power grid as it is repaired, he said. That collaboration also includes efforts to clear roads for deliveries of supplies and to provide fuel and electrical generators for the companies, Gottlieb said. — Gregory Roberts