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Florida senators press HHS to use domestic IV manufacturers to ease shortages

by
October 31, 2024
in Health Care
0
Florida senators press HHS to use domestic IV manufacturers to ease shortages

Florida Sens. Marco Rubio (R) and Rick Scott (R) are questioning why the Biden administration hasn’t done more to leverage domestic IV fluid manufacturing in the wake of shortages caused by Hurricane Helene. 

Hospitals were left scrambling after the storm flooded a Baxter manufacturing plant in Marion, N.C.  

The plant makes about 60 percent of the IV fluid in the country, including hydration and dialysis solutions. The resulting shortage forced hospitals to ration supplies. Some said they were postponing elective surgeries, and some were restricting the use of IV bags except in cases of emergency. 

“Although the administration attempted to help mitigate the shortage of IV supply in the weeks following the hurricane, we remain concerned that the delayed execution of these efforts may lead to longer-term consequences,” the senators wrote.  

In a letter to Health and Human Services (HHS) Secretary Xavier Becerra, the senators asked why the agency has yet to invoke the Defense Production Act to help small manufacturers boost their production and close the supply gap while Baxter repairs its facilities. 

Baxter’s North Cove plant shut down in late September, when record amounts of rainfall from Helene inundated western North Carolina communities, including Marion. Federal officials subsequently approved temporary imports of IV fluid from Baxter facilities in Ireland, the United Kingdom, Canada and China.   

HHS invoked the Defense Production Act to help Baxter obtain materials needed to clean and rebuild the North Cove facility. The authorization gave Baxter priority access to a particular material needed to continue the remediation process and prepare for the restart of production. 

But Rubio and Scott questioned why the agency hasn’t also invoked the act to help other, smaller companies. 

“While importing supply from approved manufacturers abroad can be helpful in the short-term, HHS must do more to expand approvals and resources to all capable domestic IV fluid manufacturers by invoking the Defense Production Act (DPA) and other agency supportive actions to increase domestic production,” they wrote.  

They also asked whether the federal government plans on extending the shelf life of all sterile IV and peritoneal dialysis solutions, rather than just certain Baxter products.  

The Food and Drug Administration this week said multiple types of intravenous and sterile fluids made by Baxter can be used up to two years after manufacturing, instead of the previous one year. 

Baxter on Thursday said it had restarted the highest-throughput IV solutions manufacturing line, but the earliest that new North Cove product could start to ship is late November. Baxter said it still does not have a timeline for when North Cove production will be fully restored to pre-hurricane levels. 

“HHS must also commit to greater transparency in its actions regarding the current available supply so healthcare providers can plan accordingly,” the senators added. 

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