As a result of these actions, significantly more IV fluid is available this week versus last week, with increased access expected in coming weeks

October 11, 2024 – Following storm damage from Hurricane Helene at Baxter International Inc.’s facility in North Carolina, the Biden-Harris Administration continues taking action to support access to 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 this week compared to last, and access is expected to continue to increase in the weeks to come.

Moving and Protecting Product:

• Restoring access to Baxter facility. In the hours after the hurricane, the federal officials immediately began assessing damage to Baxter’s North Cove facility. Three bridges to the facility were heavily damaged by Helene, and ASPR and FEMA worked with Baxter to regain access to the plant and engage in recovery efforts.
• Moving supply for the last week. Much of the inventory in the North Carolina plant has been saved, and Baxter began moving truckloads of product out of the damaged facility on Sunday, October 6.
• Protecting product in Florida. One manufacturer, B. Braun, has a manufacturing facility in Daytona, FL. ASPR worked to proactively move 60 truckloads of IV fluids out of the Daytona plant, ensuring it was safe from Hurricane Milton impact.

As a result of the swift action to restore access, on October 9th, Baxter was able to announce increased product allocation, with hospitals able to order 50% more product than the prior week. Hospital allocation increased from 40% to 60% and distributor allocations increased from as low as 10% to 60%. This sharp increase in product availability will be felt over the coming days.

Increasing U.S. Supply:

• FDA regulatory action to allow additional imports. As of October 9, FDA announced the temporary importation of 19 different IV solution and dialysis products from 5 different international manufacturing plans to bolster domestic supply. FDA continues to evaluate additional options around the world.
• ASPR supporting transportation. ASPR is supporting efforts to airlift new product into the U.S. to get it to patients as quickly as possible.
• Expanding compounding of IV solutions. On October 11, FDA released guidance providing new flexibilities related to compounding of IV solutions. This guidance will also make it easier for hospitals and other facilities to make their own IV solutions during the shortage.
• Expediting other reviews. HHS is working with manufacturers in the U.S. and around the world to increase their production capacity. FDA is expediting regulatory reviews and ASPR is providing technical assistance.
• Extending shelf-life. FDA will expedite consideration of any shelf-life extension requests manufacturers submit for short-dated product.
• Preventing price gouging. The federal government has already put companies on notice that price gouging for essential medical supplies like IV solutions will not be tolerated. On Wednesday the Justice Department, Federal Trade Commission and the Consumer Financial Protection Bureau warned that law enforcement would use every tool available to stop price gouging, price fixing, and other illegal scams. They encourage people to report violations at http://www.justice.gov/DisasterComplaintForm or http://www.reportfraud.ftc.gov/.

Baxter will further increase allocations in the weeks to come based on these actions. Updates on storm response efforts can be found at their website .

Reopening North Cove

• Using the DPA. HHS has invoked the Defense Production Act to help Baxter obtain materials needed to clean and rebuild the facility, and ASPR continues to actively pursue additional opportunities to invoke DPA authorities.
• Staffing response. 1,500 people are in the North Cove facility helping to clean up and restore production lines.
• Expediting inspections. FDA has also stated publicly that it will expedite any inspections or regulatory actions needed to re-open North Cove.

Baxter expects to restart North Cove production in phases and further increase allocations to customers to 90%-100% by the end of the year.

In response to storm damage from Hurricane Helene at Baxter International Inc.’s facility in North Carolina, HHS, FDA, and ASPR and Baxter International Inc. leadership held a joint briefing on Thursday, October 10 for more than 3,000 patients, caregivers, physicians, health care facilities, and intergovernmental stakeholders.

On the call, Secretary Becerra outlined HHS’ efforts to address supply chain disruptions as a result of Hurricane Helene, and detailed HHS’ work with Baxter and other manufacturers, state partners, hospitals, medical product distributors, and other stakeholders to bolster supply and mitigate impact to patients over the coming weeks.

This call was one of many stakeholder briefings held by HHS in response to the effects of Hurricane Helene on Baxter’s manufacturing facility in North Cove, North Carolina. On Friday, October 4, HHS hosted a stakeholder webinar for more than 2,500 individuals to answer questions about HHS’s initial response. HHS also met with national hospital associations, kidney disease stakeholders, Congressional, state and local government offices, and more on Tuesday, October 8 and Wednesday, October 9 to answer questions on the Administration’s work to address supply chain disruptions.