Amid Hurricane Helene shuttering a major IV solution manufacturing plant and Hurricane Milton now barreling toward other IV manufacturing facilities in central Florida, the American Hospital Association on Monday asked the Biden administration to declare a shortage of IV solutions and invoke national emergency powers to ease the crisis.
In late September, Hurricane Helene shut down a Baxter plant in Marion, N. C., which manufactures approximately 60% of the IV solutions for the U.S. Both Baxter and “all other suppliers” of IV solutions have restricted how much their customers can order and have stopped taking new customers, AHA president Rick Pollack wrote in the organization’s letter to Biden. As a result, hospitals have declared internal shortages and restricted IV use.
The AHA is asking the administration to direct the Food and Drug Administration to take steps including declaring a national shortage, extending expiration dates, and allowing hospitals to prepare their own sterile IV solutions.
In addition, the letter asked for the government to declare a national emergency and public health emergency so that Medicare and Medicaid rules around IV infusions can become more flexible, and to invoke the Defense Production Act to expand the production of IV solutions and bags. The AHA also suggested the government put the Federal Trade Commission and Department of Justice on alert for price gouging during the shortage.
Another step the FDA could take is to allow the importation of IV bags from other countries, as it did when Hurricane Maria shut down Baxter’s Puerto Rico-based IV saline plants in 2017. That shortage mostly affected small IV bags. According to Vizient, a health care performance improvement company, the North Carolina Baxter plant is largely a producer of large IV bags, including saline, dextrose, and Ringer’s lactate solutions.
B. Braun, another major IV supplier, has an IV solutions manufacturing plant in Daytona Beach, Fla., which is in the projected path of Category 5 Hurricane Milton.
Allison Longenhagen, a spokesperson for B. Braun, told STAT in a statement that the company is monitoring the path of Hurricane Milton. The Daytona Beach B. Braun plant has initiated its hurricane response plan and is focused on protecting its employees and limiting the impact on the IV solutions supply, she said. B. Braun supplies about 23% of the U.S. IV market.
In a more detailed statement released Tuesday afternoon, Longenhagen said that the Daytona Beach manufacturing plant and distribution center will close on Wednesday morning in anticipation of the storm and will reopen on Friday morning. The company is working with the federal Administration for Strategic Preparedness and Response (ASPR) to move finished products from Daytona Beach to a secure facility north of Florida until the storm passes. B. Braun is also working with ASPR to help mitigate the shortage by ramping up production at its Irvine, Calif. plant, as well as at Daytona Beach after Milton passes.
Though Baxter doesn’t have a timeline for the reopening of its North Carolina plant, it said in a statement that some of the recovery involves reinstating bridges that were damaged in the storm, which are needed to transport repair equipment to the site as well as to ship stored finished products to customers. In an update Monday evening, Baxter noted a temporary bridge had been installed, which allowed it to make shipments to hospitals and dialysis patients. According to early inspections, the building did not sustain any structural damage, and the company expects to decide on its future production plans in the next two weeks.
Alex Lucio, CEO of new IV fluid manufacturer Assure Infusions, said that he is estimating that the North Carolina Baxter plant will be out of commission for nine to 12 months. Lucio is starting a new, fully automated IV solutions plant in Bartow, Florida which is slated to open in January. But even at its full capacity, the new Assure factory will only be able to manufacture 30 million bags — around 5% of the annual supply of IV bags, he said.
This story has been updated.
