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Baxter Update - October 31, 2024
Below are the latest updates related to supply. Read the full update here.
Facilities and Infrastructure: As previously shared, and in coordination with FDA, our goal remains to begin resuming North Cove production in phases by the end of this year.
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NEW: We are pleased to announce that Baxter has restarted the highest-throughput IV solutions manufacturing line. At its peak operation (prior to Hurricane Helene), this line represented approximately 25% of the site’s total production and approximately 50% of the site’s production of one-liter IV solutions, the most commonly used size by hospitals and clinics.
Supply Continuity: We are grateful for the ongoing partnership and efforts of our customers as we navigate this complex and challenging situation to prioritize patient care.
IV Solutions Allocations:
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In the U.S., allocation levels for both direct customers and distributors remain as previously communicated by Baxter on Oct. 9th.
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Based on 1) the current status of our North Cove remediation efforts, 2) our expectations regarding our ability to reallocate capacity from other Baxter facilities, and 3) temporary importation on certain products, our goal remains to return to 90% to 100% allocation of certain IV solution product codes for U.S. customers by the end of 2024.
NEW: U.S. PD Patient Starts: We have begun to expand our support for new peritoneal dialysis (PD) patients on a limited basis, beyond the highly restricted medical exceptions to date, to help providers address urgent medical needs. The volume of new patients should continue to increase in the coming weeks, with the goal of returning to pre-Hurricane Helene levels for new patient starts by the end of the year.
PD Solutions Allocations and Ongoing Patient Support:
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We are closely partnering with the kidney community, including physicians, nurses and care teams, to enhance our support for patients. This includes working to improve the ordering and delivery process to help reduce wait times and increase the accuracy of our target delivery dates and times. We are grateful to have excellent provider partners, who have been agile and proactive in helping us meet patient needs while conserving supply. Because PD patients have individualized prescriptions, this has allowed for some additional flexibility in our ongoing ability to support them within the allocation protocols already put in place.
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While the allocations for PD solutions in the U.S. currently remain as communicated with patients and clinicians, thanks to FDA’s recent temporary importation authorizations, we are temporarily importing additional product into the U.S. to help support supply. We will be providing training and education materials in the first part of November so that patients and care teams can prepare to use these imported PD solutions. Our global footprint and quality standards have allowed us to rapidly respond and shift supply accordingly, to help address the needs of existing and new patients in the U.S.
Resources for Healthcare Professionals and Customers
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