A nationwide assessment of climate-related disaster events between 2019 and 2024 shows that nearly two-thirds of U.S. drug manufacturing facilities were in counties that experienced at least one disaster declaration, according to a research letter published in JAMA.
Of the nearly 11,000 drug production facilities active during the six-year study period, more than 6,800 facilities (62.8%) were in counties that experienced at least one FEMA Presidential Disaster Declaration, with an annual average of over 2,100 facilities (33.8%).
While all types of climate-related disasters impacted counties with active drug production facilities, such as fires, floods, storms, and tornadoes, researchers found that hurricanes were the most common.
“These disaster events posed risks of disruptions to facilities active in all aspects of the supply chain, from active pharmaceutical ingredient manufacture to packaging, disruptions that could be further magnified by the time needed for FDA reinspection of damaged facilities,” the authors wrote.
Leveraging the FDA’s Drug Establishments Current Registration Site, the researchers identified all U.S. facilities that manufactured, prepared, propagated, compounded, or processed drugs from 2019 through 2024. They cross-referenced these sites with counties that had a FEMA Presidential Disaster Declaration. Using logistic regression, the researchers calculated the relative odds of disaster impact by whether a county had drug production facilities, with year fixed effects and errors clustered at the county level.
The authors of the study contend that their findings highlight significant vulnerabilities in the U.S. pharmaceutical supply chain and the urgent need for strategic planning to ensure resilience, given the threats of climate change.
“These findings underscore the importance of recognizing climate-related vulnerabilities and the urgent need for supply chain transparency, for strategic allocation of production, and for disaster risk management strategies to prevent health care disruptions in the U.S.,” the authors concluded.
Mitigating the threats of weather disasters to America’s drug manufacturing facilities is more important than ever, they said, “especially in light of the current administration’s recent executive order and policy proposals seeking to increase domestic pharmaceutical production.”
The researchers pointed out that Hurricane Helene in September 2024 caused a nationwide shortage after hitting a Baxter facility in North Carolina that produces 60% of intravenous (IV) fluids in the U.S., and a similar IV shortage resulted when Hurricane Maria hit Puerto Rico in 2017.
While drug shortages following disasters demonstrate the vulnerability of the pharmaceutical supply chain, researchers acknowledged that data on how frequently disasters resulted in such shortages are not readily available, “hindering a nationwide assessment of weather-induced drug shortages and their impacts.”
The study’s limitations include a lack of information on production volume, drug types, facility-level contributions to the U.S. drug supply, or the proportion of drugs consumed in this country that are manufactured domestically, according to the authors.
“We used counties as the unit of analysis, which may mask variability in facilities’ vulnerability to disasters within counties,” they wrote. “However, FEMA Presidential Disaster Declarations are only issued for major disasters, which typically disrupt transportation and resource availability and may indirectly affect production.”
