Weathering the Storms

The 2024 fall season has already seen perilous weather conditions impacting many areas of the world, none more so than the southeastern coastal states of the United States. Towards the end of September, the US was hit by Hurricane Helene, which underwent rapid intensification as it traveled over warm ocean waters, and was then swiftly followed by five further hurricanes, including Hurricane Milton (1).

These recent storms have caused significant damage, with major efforts already underway to provide assistance to affected areas. However, for the healthcare industry, there are wider-reaching issues arising from the devastation of the storms.

In North Cove, Marion, NC, Baxter’s largest manufacturing facility was flooded, and bridges accessing the site were damaged, resulting in the facility being forcibly closed. This facility is, in fact, the largest manufacturing site for intravenous and peritoneal dialysis solutions in the US, and its closure has led to nationwide shortages of certain medicines (2).

“Our goal is to begin restarting North Cove production as soon as possible and in phases by the end of this year. We do not yet have a timeline for when we expect production to be fully restored to pre-hurricane levels,” Baxter stated in a progress update press release (3).

Responding to the shortages, FDA has added three new parenteral products to its drug shortages list and released guidance for the temporary compounding of certain parenteral products to help fill any supply gaps. Additionally, FDA is assessing potential imported products to help meet patient needs within the US (4).

However, the disruption being caused by this weather-related emergency should further intensify governmental assessments of the fragility and opacity of the US pharma supply chain—facets that have been under scrutiny for some time (5).

References

1. Poynting, M.; Dale, B.; Rivault, E.; Rogers, L. How Unusual Has this Hurricane Season Been? BBC News, Oct. 11, 2024.
2. Baxter. Baxter Provides Update on North Cove, N.C., Facility and Hurricane Helene Relief Plans for Community. Press Release, Sep. 29, 2024.
3. Baxter. Hurricane Helene Updates. Press Release, Oct. 21, 2024.
4. FDA. Hurricane Helene: Baxter’s Manufacturing Recovery in North Carolina. FDA.gov (accessed Oct. 21, 2024).
5. HSGAC. Short Supply: The Health and National Security Risks of Drug Shortages. Staff Report, March 2023.

About the author

Mike Hennessy Jr is president and CEO of MJH Life Sciences®

Article details

Pharmaceutical Technology®
Vol. 48, No. 11
November 2024
Page: 7

Citation

When referring to this article, please cite it as Hennessy, M. Weathering the Storms. Pharmaceutical Technology 2024 48 (11) 7.