Already scrambling to deal with a shortage of saline in the U.S., the FDA now says it is taking extraordinary measures to help get hospitals supplies of products needed to intravenously feed infants after production was disrupted by hurricane damage in Puerto Rico.
The FDA is working with Baxter to import products it produces for IV feeding of children and adults from facilities in the United Kingdom and Italy, the agency said. Baxter is one of the largest suppliers to the U.S. of IV amino acids for feeding children and adults, but much of that is produced in Puerto Rico.
It is also working with other makers of the products, particularly ICU Medical and B. Braun. But ICU Medical, which last year bought Hospira’s infusion business from Pfizer for $1 billion, is already dealing with manufacturing issues that have taken its products out of production. The FDA said it plans to return to the market soon.
Baxter has three manufacturing plants in Puerto Rico that make infusion products including saline and amino acids. Like like other drugmakers it has had a hard getting production back to normal levels for want of steady power because Puerto Rico continues to struggle with its power grid after it was devastated by hurricanes Irma and Maria.
Many companies are running facilities on backup generators, but have even had difficulty getting enough fuel to power those. They have also faced difficulties getting products off the island.
Earlier this month, FDA Commissioner Scott Gottlieb said that the FDA asked state and federal authorities to put a “subset of critical production facilities,” including Baxter’s plants, ahead of other companies in getting power restored.