NOTICIAS

Hurricane Helene significantly damaged North Carolina’s Baxter International IV fluid manufacturing plant. Baxter is responsible for producing more than half of the country’s IV fluid supply. This closure has strained the medical community, leading to delays in non-emergency procedures as providers conserve IV supplies for urgent needs. 

U.S. Senators Marco Rubio (R-FL) and Rick Scott (R-FL) sent a letter to U.S. Department of Human Health Services (HHS) Secretary Xavier Becerra requesting the use of the Defense Production Act to help smaller manufacturers increase production of IV fluids to support our nation’s healthcare facilities during the shortage.

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

El texto de la carta en inglés está aquí. . 

Dear Secretary Becerra:

We write with regard to the shortage of IV fluids and what seems to be the U.S. Department of Health and Human Services’ (HHS) hesitance to fully leverage the domestic IV fluid manufacturing sector in the wake of Hurricane Helene.

As you are aware, Hurricane Helene caused significant damage across many states in the Southeast that led to the destruction of thousands of homes and businesses. The intense flooding in western North Carolina led to the temporary closure of the Baxter manufacturing plant in Marion, North Carolina. As Baxter handles the production of approximately 60 percent of the country’s IV fluid supply, the closure and rationing of supply from this plant have raised considerable concern across the medical community.

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. Providers have already begun to delay procedures to conserve their supply for those with the most need. As we learned during COVID, delaying procedures can lead to worse outcomes for patients, so it is critical for our nation’s supply of IV fluids to be restored as soon as possible. Further, it is essential that healthcare providers are fully stocked with IV fluids to treat the anticipated increase in patients during the winter respiratory season. 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. HHS must also commit to greater transparency in its actions regarding the current available supply so healthcare providers can plan accordingly.

Maintaining an adequate supply of IV fluids is critical for the safety and stability of our healthcare system, particularly as many states rebuild after this year’s hurricane season. HHS has a responsibility to ensure the gap in supply is quickly resolved. We respectfully request your response to the following questions.

1. Why has the HHS not invoked the DPA to empower smaller, domestic actors in the IV manufacturing sector to boost their production and support the supply gap while Baxter repairs its facilities?
2.  Does the U.S. Food and Drug Administration intend to extend the shelf life of all sterile IV and peritoneal dialysis solutions near or past their expirations to support healthcare facilities in shortage?
3. How is HHS ensuring safety and quality of IV supply that is imported to help mitigate the shortage? 
4.  How is HHS evaluating how they can improve their response protocols and timeline for future shortages?

Thank you for your attention to this matter. We look forward to your prompt response. 

Atentamente,