The 1st shipment of Baxter IV fluids has been airlifted into the U.S. from international facilities. HHS is committed to ensuring Americans have the medical supplies they need & providing support to Baxter as it returns to its full operational capacity following Hurricane Helene.

Continuing efforts to ensure product is available in the domestic market and current inventories are appropriately conserved

October 20, 2024 - Following storm damage from Hurricane Helene at Baxter International Inc.’s facility in North Carolina, the U.S. Department of Health and Human Services (HHS) and its subagencies continue taking action to support access to intravenous (IV) fluids, including ensuring restoration of key production sites, protecting products, and opening imports, in partnership with manufacturers, distributors, hospitals, and other stakeholders. As a result of these steps, hospitals have 50% more product available to them now compared to right after the hurricane. Baxter has moved and begun distributing more than 450 truckloads of product from their North Carolina facility over the past 10 days and is already importing additional product from their foreign plants. FDA acted quickly to conduct scientific and regulatory assessments to help facilitate the temporary importation of 23 different IV and peritoneal (PD) fluids from five Baxter facilities around the world. Baxter communicated that supply availability is continually improving and they expect to further increase customer allocations to 90%-100% of historical levels for many IV solution product codes no later than the end of the year. These supply improvements, combined with increased output from other manufacturers, will help hospitals get more of the product they need over the coming weeks.

HHS, Food and Drug Administration (FDA), the Administration for Strategic Preparedness and Response (ASPR), and the Centers for Disease Control and Prevention (CDC) continue to use all available authorities to protect patients, support supply, and keep stakeholders informed, in partnership with manufacturers, distributors, hospitals, and other stakeholders. Additionally, HHS is announcing additional information about the airlift of Baxter products into the U.S. from international facilities, with first flights scheduled for October 19.

NEW: Airlifting in International Product

• Importing IV solution to the U.S. While Baxter North Cove is returning to full operational capacity, ASPR is supporting Baxter’s efforts to airlift their product into the U.S. Baxter and ASPR have been collaborating with the FDA, DHS customs officials, and aviation partners to rapidly bolster domestic supply through the importation of Baxter’s international product that has been granted regulatory flexibility by the FDA. Over the coming weeks this will include millions of units of product from at least four different international facilities.
• First flights on October 19. The first flights are scheduled to arrive starting on Saturday, October 19. Each flight will carry over 100,000 units of Baxter products from international facilities. Product will continue to be airlifted in the coming weeks to assist in meeting domestic demand as Baxter progresses its remediation efforts at the North Cove facility. The product coming into the United States as part of this effort will be distributed through normal distribution channels consistent with Baxter’s current projections. In partnership with Baxter, ASPR has enabled expedited distribution once reaching the U.S., reducing typical distribution times from 5-10 days to less than a day in some cases.

Supporting Domestic Supply:

• Reopening the North Cove facility. Baxter’s more than 2,500 North Cove employees are now returning to work across multiple round-the-clock shifts, during which they are focused on site remediation and equipment assessment efforts. Progress in restoring physical facilities has exceeded expectations, including full restoration of utilities and IT infrastructure. The building is structurally sound, and phased testing of priority equipment will soon support resumption of line operations in phases. ASPR is actively working with Baxter and FEMA to support infrastructure repairs and ensure the facility resumes operations as quickly as possible. ASPR is coordinating with FEMA leadership and the Army Corp of Engineers to support additional bridge access to the facility. In addition, FDA has committed to expedite any and all necessary regulatory actions needed to help bring North Cove back on-line as quickly as possible. Baxter has also moved more than 450 truckloads of product that was produced prior to the hurricane out of the facility and into the supply chain.
• Product assessment action. FDA acted quickly to conduct scientific and regulatory assessments to help facilitate the temporary importation of IV and PD fluids. To date, FDA has announced regulatory discretion for 23 different product lines at five Baxter facilities around the world. These facilities are currently ramping up production to increase supply available to the U.S. FDA is expediting reviews of enforcement discretion in additional circumstances, including considering requests from other manufacturers of IV and PD fluids. 
• Defense Production Act use. The USG is actively working to help increase manufacturing capacity for these critical products. HHS has invoked the Defense Production Act to help Baxter obtain materials needed to clean and rebuild the North Cove facility. ASPR has issued a priority rating to Baxter for a remediation material they were unable to secure. This product was a limiting factor in their ability to restart production. ASPR is engaging with manufacturers to identify any other supply chain challenges that may require DPA authorities.
• Compounding flexibilities. In general, drugs on the FDA shortage list can be compounded to support domestic supply, with fewer restrictions than those that apply to drugs that are not on the FDA shortage list. FDA released an immediate-implementation guidance which provides additional flexibilities to support more timely production and distribution of certain compounded IV solutions by hospitals and other facilities during the shortage, while still ensuring appropriate safeguards are in place. The agency has also received questions about its draft guidance for industry on hospital and health system compounding under section 503A. In 2021, FDA revised that draft guidance to, among other things, remove a provision about the distribution of the compounded drug beyond a one-mile radius. FDA reiterates that there is no one-mile radius policy. In addition, although the 2021 draft guidance proposes the such compounded drugs be used within 24 hours, the new guidance for immediate implementation includes no such provision.

Conservation Efforts:

• HAN advisory. On October 11, CDC issued Health Alert Network (HAN) Health Advisory to inform healthcare providers, pharmacists, healthcare facility administrators, and state, tribal, local, and territorial health departments of a supply disruption of IV and PD solutions from the Baxter International’s North Cove facility in North Carolina, due to Hurricane Helene. The supply disruption may impact patient care and require adjustments to the clinical management of patients, particularly for institutions that operated a just-in-time supply for these products. CDC is encouraging healthcare providers, pharmacists, healthcare facility administrators, and state, tribal, local, and territorial health departments, regardless of product availability status, to immediately assess their supply and develop plans and mitigation strategies to reduce the impact on patient care.

Stakeholder Communications:

HHS continues to keep relevant stakeholders informed on the progress of the effort.

• Upcoming stakeholder call. HHS will hold its third large stakeholder call with HHS leadership and Baxter executives on Friday, October 18, 2024.
• FDA updates. FDA has established a designated website for essential Hurricane Helene response FDA updates.
• Additional information. HHS has released two prior public documents, a stakeholder letter and prior fact sheet.

Press or Other Inquiries:

• HHS inquiries. HHS stakeholder inquiries can be sent to HHSIEA@hhs.gov and press inquiries to press@hhs.gov.
• Baxter inquiries. Baxter publicly committed to updating their webpage  every Monday and Thursday. Additionally, Baxter has created a resource mailbox to track and route inquiries. That mailbox is: hurricanehelenesupport@baxter.com .
  Source: HHS