U.S. Senate Committee on Rules and Administration

10/08/2024 | Press release | Distributed by Public on 10/08/2024 12:49

Klobuchar Calls on Administration To Take Action To Address Shortage Of IV Solutions Caused by Hurricane Destruction

WASHINGTON - U.S. Senator Amy Klobuchar (D-MN) is urging U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra and administration officials to use all appropriate authorities to resolve the national shortage of intravenous (IV) solutions caused by the halt in production at the North Carolina IV fluids manufacturing plant hit by Hurricane Helene. Klobuchar also warns that another plant in Daytona Beach, Florida that manufactures IV solutions could also become compromised by fast-approaching Hurricane Milton, exacerbating the existing shortage.

"Flooding from Hurricane Helene compromised the safe operations, inventory, raw materials and roadway access at Baxter International's intravenous (IV) solution plant in Marion, North Carolina," wrote Senator Klobuchar. "The plant - the largest manufacturing facility of IV solutions in the country - has been forced to cease production. This dangerous situation may be further exacerbated by fast-approaching Hurricane Milton, which may affect the operation of a Daytona Beach, Florida IV solutions plant."

"To address the potentially life-threatening shortage of IV solutions, I urge the Department of Health and Human Services to use all of its available authority to mitigate this devastating situation which threatens patient care, the work of medical and provider staff, and our emergency response readiness," Klobuchar continued. "In addition to using your authority to address this shortage as quickly and safely as possible, I urge you to coordinate with the Federal Trade Commission and Department of Justice to prevent the distribution of counterfeit IV solutions."

Klobuchar has been a national leader in efforts to address prescription and over-the-counter drug shortages.

In June, Senator Klobuchar chaired an Antitrust Subcommittee hearing titled "Strengthening U.S. Economic Leadership: The Role of Competition in Enhancing Economic Resiliency." The hearing focused on the danger of consolidation in critical supply chains, which can make the country vulnerable to disruptions and supply shortages that can endanger U.S. economic resiliency and national security.

In July 2023, Klobuchar, and Senators Susan Collins (R-ME), Tina Smith (D-MN), Lisa Murkowski (R-AK), and Elizabeth Warren's (D-MA) bipartisan legislation to prevent and mitigate drug shortages was passed out of the Health Education Labor and Pensions (HELP) Committee on a bipartisan vote of 17 to 3. The Drug Shortage Prevention Act would require manufacturers of over-the-counter and prescription medicines to notify the U.S. Food & Drug Administration (FDA) when they are unlikely to meet demand. The legislation also requires drugmakers to provide information about their suppliers of active pharmaceutical ingredients and in-process materials to the FDA.

In 2012, Klobuchar and Senator Bob Casey (D-PA) led the Preserving Access to Life-Saving Medications Act, which Collins also cosponsored. This bipartisan legislation was signed into law as part of the Food & Drug Administration Safety & Innovation Act of 2012 (FDASIA). The Klobuchar law allows the FDA to require drug manufacturers to report to the FDA six months in advance if any supply or manufacturing disruption could lead to a prescription drug shortage. The law also created the Drug Shortage Prevention Task Force and requires the FDA to submit a report to Congress every year on drug shortages. In 2023, the number of new drug shortages tracked by FDA was 33, compared to a peak of 251 new shortages during 2011, before Klobuchar's 2012 bill was passed into law giving FDA more tools to prevent shortages.

The full text of the letter is available HERE and below:

Secretary Becerra,

As you know, Hurricane Helene left a trail of destruction and flooding across much of the southern United States. This natural disaster has caused widespread disruption to vital services across the region and country. Notably, flooding from Hurricane Helene compromised the safe operations, inventory, raw materials and roadway access at Baxter International's intravenous (IV) solution plant in Marion, North Carolina. The plant - the largest manufacturing facility of IV solutions in the country - has been forced to cease production. This dangerous situation may be further exacerbated by fast-approaching Hurricane Milton, which may affect the operation of a Daytona Beach, Florida IV solutions plant.

To address the potentially life-threatening shortage of IV solutions, I urge the Department of Health and Human Services to use all of its available authority to mitigate this devastating situation which threatens patient care, the work of medical and provider staff, and our emergency response readiness.

As you know, the Baxter facility is responsible for the manufacture of approximately 60 percent of IV fluids and peritoneal dialysis solutions available to health care providers in the United States. As a result of Hurricane Helene, hospitals, dialysis centers, and other health care providers around the country-including many in Minnesota-are already being forced to ration these basic, but life-saving supplies. This means many patients have no choice but to delay starting dialysis, delay elective care, or potentially receive suboptimal treatments. Hospitals and health providers are now canceling elective surgeries, such as cardiovascular and other surgical operations, and canceling organ transplants.

In addition to using your authority to address this shortage as quickly and safely as possible, I urge you to coordinate with the Federal Trade Commission and Department of Justice to prevent the distribution of counterfeit IV solutions. Steps must be also taken to ensure that companies advertising or selling FDA-approved IV solutions do not engage in price gouging or other illegal practices. I also urge the administration to implement strategies outlined in recent federal supply chain and manufacturing resilience assessments to mitigate any supply and distribution disruptions.,, Today, few companies in the United States make IV solutions, with a majority share flowing from a single plant. No single entity should be responsible for such a large proportion of fundamental medical supplies on which the health of our nation depends.

Thank you for your continued efforts as we recover from the devastation of Hurricane Helene and for your attention to this urgent matter.

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