UPDATED: Thursday, Nov. 21, 4 p.m. ET
Baxter International this week released the first product – 1-liter IV solutions – manufactured post-hurricane at its North Cove, North Carolina facility.
The product release is ahead of the company's original expectations and made possible by the dedication and resilience of the North Cove and broader Baxter teams, working in coordination with FDA, the company said in an update posted to its website.
Baxter announced October 31 it restarted its highest-throughput intravenous solutions manufacturing line at its hurricane-hit North Cove facility.
"We are making continued strong progress at our North Cove site, including the recent resumption of two manufacturing lines that represent ~50% of the site’s total pre-hurricane production and ~85% of the site’s production of 1-liter IV solutions, the most commonly used size by hospitals and clinics," company executives said in the update.
Baxter currently expect that peritoneal dialysis (PD) solutions and irrigation will be the next two manufacturing lines to restart in early December.
The company expects all lines will be restarted by the end of the year, but Baxter does not yet have a timeline for when it expects North Cove production to be fully restored to pre-hurricane levels.
The company—the U.S.’ top supplier of hospital IV fluids and peritoneal dialysis solutions—reduced its orders to hospitals and health systems after Hurricane Helene took down its North Cove facility, one of its largest manufacturing plants.
In the U.S., allocation levels for both direct customers and distributors remains the same as the company announced on Oct. 9 at 60%.
Baxter expects to communicate details on the next planned allocation increases to U.S. customers on Nov. 25, the company said.
Barring any unanticipated developments, Baxter expects to reach 100% allocation across several IV product categories by the end of the year with additional details on planned, phased increases in allocations in late November, mid-December and end of year.
To help increase available inventory of IV solutions products, Baxter activated nine plants across its global network.
The company also received FDA authorization to extend the use dates of 50+ IV and irrigation codes to provide up to an additional 12 months of expiry. Products now have a 24-month expiry period from the date of manufacture. This extension only applies to products manufactured prior to the end of September 2024.
UPDATED: Friday, Nov. 1, 12 noon ET
Baxter International restarted its highest-throughput intravenous solutions manufacturing line at its hurricane-hit North Cove facility in North Carolina, the company announced Thursday.
At its peak operation, prior to Hurricane Helene, manufacturing 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.
Baxter said initial batches will be manufactured concurrently with ongoing quality activities and will only be released in accordance with applicable regulatory requirements to ensure the quality and safety of the products.
The earliest that new North Cove product could start to ship is late November, the company said in an update on its website.
The company—the U.S.’ top supplier of hospital IV fluids and peritoneal dialysis solutions—reduced its orders to hospitals and health systems after Hurricane Helene took down one of its largest manufacturing plants in North Cove, North Carolina, on Sept. 29.
In the U.S., allocation levels for both direct customers and distributors remains the same as the company announced on Oct. 9 at 60%.
The company said assessment and repair of equipment with phased testing continues to progress across all other production lines, which will, in coordination with FDA, support resumption of operations in phases.
The company does not yet have a timeline for when it expects North Cove production to be fully restored to pre-hurricane levels.
Baxter is restarting manufacturing of IV solutions at the North Cove plant ahead of the company's original expectations, the company said. And, company executives credited the "urgency, diligence and resiliency of the North Cove and broader Baxter teams" to accelerate recovery in coordination with federal agencies, namely, the Food and Drug Administration, Administration for Strategic Preparedness and Response (ASPR) and the Department of Health and Human Services (HHS).
“Recovery progress at our North Cove site continues to be very encouraging. In a matter of weeks, our team has advanced from the depths of Hurricane Helene’s impact to restarting our highest-throughput manufacturing line. This is a pivotal milestone, but more hard work remains as we work to return the plant to full production," José E. Almeida, chair, Baxter International president and chief executive officer said in a statement. "I want to recognize the dedication of our North Cove team as well as the countless Baxter employees globally who have committed themselves to helping contribute to supply continuity amid this unprecedented challenge. I also offer Baxter’s gratitude for the steadfast support of ASPR, FDA, the State of North Carolina and HHS. And we are deeply appreciative of our customers’ patience and partnership as progress continues.”
On Monday, Baxter said it received FDA authorization to extend the use dates of 50+ IV and irrigation codes to provide up to an additional 12 months of expiry. Products now have a 24-month expiry period from the date of manufacture, the company said. This extension only applies to products manufactured prior to the end of September 2024.
UPDATED: Thursday, Oct. 24, 5 p.m. ET
Baxter International said Thursday it anticipates restarting its highest-throughput IV solutions manufacturing line within the next week.
Initial batches will be manufactured concurrently with ongoing quality activities and would only be released in accordance with applicable regulatory requirements to ensure the quality and safety of the products, the company said on its hurricane update page Thursday.
"It is important to note that the earliest that new North Cove product could begin entering the distribution channel is mid- to late-November. This is, however, ahead of our original expectations and is a testament to the urgency, diligence and resiliency of the North Cove and broader Baxter teams as we’ve worked to accelerate recovery, with the support of FDA, ASPR and HHS," the company said referring to federal agencies.
The company—the U.S.’ top supplier of hospital IV fluids and peritoneal dialysis solutions—reduced its orders to hospitals and health systems after Hurricane Helene took down one of its largest manufacturing plants in North Cove, North Carolina, on Sept. 29.
The company has activated multiple strategies to keep IV supplies afloat.
On October 18, Baxter laid out new details on a sweeping importation plan to help critical intravenous fluids reach U.S. hospitals, Fierce Pharma reported. The first IV product shipments cleared by the FDA for temporary importation are set to arrive in the U.S. last weekend. By the end of the year, the company expects nearly 18,000 tons of product from Europe and Asia to reach the U.S.
The IV fluids will be shipped via some 200 airplanes. There is a “range of time” over the coming weeks when providers may start receiving the product, Baxter explained.
Baxter said Thursday it activated nine plants around the world.
The FDA has authorized temporary importation for a variety of product codes from two additional Baxter manufacturing facilities, in Thailand and Singapore. This brings the total number of facilities authorized for temporary importation to seven – including Canada, China (two sites), Ireland and the UK. Baxter sites in Mexico and Spain were previously FDA-approved and shipments from these sites began the week of Oct. 7.
The FDA has declared a number of IV solution products as currently in shortage and these products could be further constrained until the Baxter North Cove facility resumes operations.
HHS Secretary Xavier Becerra said in a statement Thursday that he was "encouraged" by reports that Baxter anticipates restarting the highest throughput manufacturing line at Baxter’s North Cove facility next week – sooner than originally expected.
"There’s more to do, including meeting regulatory requirements of the product manufactured on the restarted line, but this is good news for partners and patients," Becerra said.
Through public-private partnership, federal agencies have quickly facilitated the import of product from six facilities around the world and made it easier for hospitals to produce their own IV fluid during the shortage, Becerra said.
"HHS will continue to use all necessary authorities to bolster supply and mitigate impact to patients. I want to thank everyone for their continued work on this important part of the recovery process," he said.
UPDATED: Friday, Oct. 18, 7:00 a.m. ET
The Biden administration has invoked the wartime powers of the Defense Production Act to speed up rebuilding a Baxter International plant that produces IV fluids, CBS News reported Tuesday.
"Ensuring people have medical supplies they need is a top priority of the Administration. It's exactly why we are working closely with Baxter to support cleanup and restoration of the facility, including invoking the Defense Production Act to help production resume as quickly as possible," an official with the Department of Health and Human Services told CBS News on Tuesday.
A spokesperson for the federal Administration for Strategic Preparedness and Response said the federal government had wielded the act's authorities to push Baxter to the front of the line for a contractor needed for construction in the plant, the media outlet reported.
The Food and Drug Administration (FDA) announced last Friday that it had declared three more IV fluids in shortage, now adding to an ongoing shortage of other IV supplies.
Baxter International—the U.S.’ top supplier of hospital IV fluids and peritoneal dialysis solutions—said it has activated seven plants across its global network to help increase available inventory, with initial shipments beginning to make their way into the U.S. Shipments to the U.S. from two Baxter sites (Mexico and Spain) that previously had FDA-approved products began last week and more shipments are on the way, the company said in an updated statement posted on Thursday.
The company also has begun importing IV fluids from its international manufacturing facilities in Canada, China, Ireland and the UK.
"The first product shipments that FDA authorized for temporary importation are arriving in the U.S. this weekend. And, with the coordination and assistance of ASPR, by the end of the year, we project that collectively approximately 200 747 airplanes full of product will be delivered to the U.S., which represents nearly 18,000 tons of product from Europe and Asia," the company said in its statement ."There is a range of time over the coming weeks when providers may begin receiving this product. Additional details will be provided to customers in the coming days and as appropriate."
Baxter noted that there is typically a 1 to 2-week lag time for product to flow through the network.
HHS officials said in a statement last Friday, Oct. 11, that the Biden 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, the agency said, and access is expected to continue to increase in the weeks to come.
Last week, Baxter International announced it would increase hospital allocation for IV fluids 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," HHS said in its statement.
As of October 9, the 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 is supporting efforts to airlift new product into the U.S. to get it to patients as quickly as possible.
Last week, the FDA also 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.
Baxter expects to restart North Cove production in phases and further increase allocations of certain intravenous solution product codes to customers to 90%-100% by the end of the year.
UPDATED: Wednesday, Oct. 9 at 5 p.m. ET
Baxter International said Wednesday it would increase the current allocations for its highest demand IV fluid for direct customers from 40% to 60% and for distributors from 10% to 60%, according to an update on its website.
The company—the U.S.’ top supplier of hospital IV fluids and peritoneal dialysis solutions—has reduced its orders to hospitals and health systems after Hurricane Helene took down one of its largest manufacturing plants in North Cove, North Carolina, on Sept. 29.
Baxter resumed some shipments to hospitals and dialysis patients last week after a temporary hold immediately after Hurricane Helene, but the company implemented allocations to "help limit stockpiling and increase the likelihood of equitable access to available products," the company said last week.
Allocations limit what a customer can order based on historical purchases and medical necessity as well as available and projected inventory.
Baxter said it was able to increase manufacturing capacity at other sites and is now increasing the current U.S. allocation levels based on an assessment of anticipated timing of inbound products and air shipments.
"We are also increasing high concentration dextrose and sterile water for injection allocations and expect to be in a position to make additional increases for certain product codes by early November. Due to the vulnerable patient population they serve, allocations for IV solutions and nutrition products for designated children’s hospitals were increased to 100%," Baxter said in an update on its website.
"Our goal continues to be to restore customers to 100% allocation levels as soon as possible. This would be achieved through a combination of importing product from other Baxter facilities and the resumption of operations and scale up of production at our North Cove facility," the company said in its update.
Baxter said (PDF) in a securities filing that its goal is to restart production at the North Cove facility in North Carolina in phases and to reach 90% to 100% of the amount allocated for customers for certain intravenous solution products by the end of 2024, Fierce Pharma reported.
The Food and Drug Administration said Tuesday that two doses of Baxter's dextrose solutions for low blood sugar and a saline solution are in shortage.
In a letter to healthcare leaders posted Wednesday, Department of Health and Human Services (HHS) Secretary Xavier Becerra noted there are currently shortages of normal saline IV fluids, normal saline irrigation fluid, sterile water irrigation and dextrose 5% IV fluids that predate Hurricane Helene.
"The hurricane-related supply disruption at the Baxter facility will likely lead to further constraints for IV fluids. However, compounding of drugs on the U.S. Food & Drug Administration (FDA) shortage list can be done in accordance with current requirements to help alleviate shortages," Becerra said.
HHS said it is coordinating a U.S. governmentwide response to address supply chain disruptions and working with public and private partners to support the supply chain while the Baxter facility is brought back to full operational capacity.
"FDA will continue working with Baxter to identify both potential products already in their system and alternative manufacturing sites, including for potential temporary imports. As alternatives are identified, FDA is expediting assessments of those options. FDA will also expedite consideration of any shelf-life extension requests manufacturers submit for short-dated product," Becerra wrote.
The Administration for Strategic Preparedness and Response (ASPR) is providing technical assistance and support to increase manufacturing at other domestic sites where possible.
HHS also has identified the possibility of Hurricane Milton further disrupting an already fragile market.
"ASPR is currently pre-deploying assets to prepare broadly for the impacts of Hurricane Milton and working to move product away from the projected path of this next potentially catastrophic storm," Becerra said.
HHS is encouraging manufacturers, wholesalers and distributors to evaluate product allocation and healthcare providers to implement product conservation strategies. Providers and health systems, regardless of whether they have experienced a disruption in their supply, should take measures to conserve these critical products, HHS officials said.
Oct. 8, 7 a.m. ET
The American Hospital Association (AHA) wants the Biden administration to take immediate actions to increase the supply of IV solutions for hospitals, such as invoking the Defense Production Act.
The call for federal action comes as some hospitals are rescheduling non-emergency procedures as part of mitigation strategies to conserve limited stock.
Baxter International—the U.S.’ top supplier of hospital IV fluids and peritoneal dialysis solutions—said a week ago that it would temporarily shut down production at its North Cove, North Carolina-based facility as a result of the fallout of Hurricane Helene. The company said Thursday that the plant was "significantly impacted by the rain and storm surge from Hurricane Helene."
The company cautioned Thursday that it does not yet have a timeline for when operations at the North Cove site, the largest in Baxter’s global manufacturing network, will be back online, Fierce Pharma reported.
Baxter has resumed some shipments to hospitals and dialysis patients after the temporary hold last week, but the company is now reducing shipments to hospitals to "help limit stockpiling and increase the likelihood of equitable access to available products," the company announced Thursday.
Many other suppliers of IV solutions also have put their customers on strict ordering allocations and are not accepting new customers, according to the AHA.
The hospital lobby, which represents 5,000 hospitals and health systems, said providers are reporting "substantial shortages of these lifesaving and life-supporting products."
"Patients across America are already feeling this impact, which will only deepen in the coming days and weeks unless much more is done to alleviate the situation and minimize the impact on patient care," Richard Pollack, president and chief executive officer of the AHA, said in a letter to President Joe Biden.
Specifically, the AHA called for the White House to direct the Food and Drug Administration (FDA) to declare a shortage of sterile IV solutions, which will permit the use of certain flexibilities not otherwise available to health care providers.
The hospital lobby also wants the federal government to allow hospitals and health systems the flexibility to prepare sterile IV solutions within their in-house pharmacies and waive the 1-mile rule so providers can distribute the products among their facilities without a patient specific order.
Other remedies include tapping international manufacturers capable of producing sterile IV solutions and extending the shelf-life of all sterile IV and peritoneal dialysis solutions that are beyond or nearing their expiration date, the AHA wrote in its letter.
The Biden administration also has the option to declare a national emergency under the National Emergencies Act and/or the Stafford Act and request that Department of Health and Human Services Secretary Xavier Becerra declare a national public health emergency. This would allow for waivers of Medicare/Medicaid rules and regulations, the AHA wrote.
The AHA also urged Biden to invoke the Defense Production Act to require manufacturers to prioritize and accept contracts for materials and services necessary to produce sterile IV solutions while also incentivizing IV fluid makers to increase production and supply.
The hospital association noted that hospitals and health systems have implemented organization-specific action plans to conserve IV fluids.
Some health systems have canceled or rescheduled elective procedures out of concern about limited supplies of IV fluids.
M Health Fairview, a health system based in Minnesota, said it is experiencing a reduced supply of intravenous fluids.
"In response to the shortage, we are taking proactive measures to manage our supply and prioritize essential patient needs. This includes modifying our inventory management, centralizing storage, and adjusting elective procedures to conserve IV fluids. We are contacting patients who may be affected by surgery schedule changes directly," a spokesperson for the health system said in a statement to Fierce Healthcare.
"Rescheduling and delaying surgeries are decisions we do not take lightly, and we understand the impact it has on our patients," the spokesperson said.
The health system is working closely with the Minnesota Hospital Association, state and federal officials, supply chain leaders and its clinical teams to "evaluate additional relief options and to ensure the safety and quality of care remains uncompromised as we manage this temporary disruption," the health system said.
Fox9 in the Twin Cities also reported that Allina Health is rescheduling all non-emergency procedures.
On Monday, Baxter International reported the company has made "steady progress on cleanup and remediation" at the North Cove, North Carolina facility.
In addition to the flooding at the site, Baxter faced many other infrastructure challenges. The bridges leading to the site were damaged in the hurricane, which hampered transportation of remediation equipment going into the facility and some finished products unaffected by the storm that Baxter wanted to get out to customers and patients, according to Fierce Pharma.
The company reported Monday that the temporary “rock bridge” it installed is supporting transport in and out of the site and it expects a second bridge will be installed by the North Carolina Department of Transportation soon.
"We have not identified any structural damage to the facility to date, and we anticipate engineering certification within the next two weeks," the company said in a statement posted to its website on Monday.
Baxter said it expects to begin communicating anticipated production plans within the next two weeks.
The company moved finished goods from its North Cove site that were not impacted by the storm and are inspecting other finished goods onsite. This inventory will be used to support current allocations in the short term, Baxter said.
Several global plants are scaling and ramping production to help meet U.S. needs. The company said it will receive product from these sources throughout the month of October.
"We will communicate adjustments to allocations within the next two weeks as we assess timing of inbound products and shipments," Baxter said in its statement.