A recent study published in JAMA has revealed that the majority of U.S. pharmaceutical manufacturing facilities are located in areas vulnerable to natural disasters, raising concerns about supply chain resilience and patient safety. With hurricanes, floods, tornadoes, and wildfires becoming more frequent, these risks pose serious implications for drug availability nationwide.
The Scope of the Problem
Researchers from Harvard Medical School analyzed data from the FDA’s Drug Establishments Current Registration Site, cross-referencing it with Federal Emergency Management Agency (FEMA) disaster declarations between 2019 and 2024. They identified 10,861 active drug production facilities, with more than 6,800 (62.8%) located in counties where at least one disaster was declared during the study period. On average, one-third of active facilities were impacted by a disaster declaration each year.
These facilities are responsible for every stage of drug manufacturing, from the production of active pharmaceutical ingredients (APIs) to packaging. When disaster strikes, disruptions ripple through the entire supply chain, often delaying FDA reinspections and prolonging shortages.
Lessons From Recent Events
The risks are not hypothetical. In 2024, Hurricane Helene devastated a Baxter International facility in North Carolina that produced nearly 60% of the U.S. supply of IV fluids. This single event highlighted how concentrated manufacturing capacity can magnify the effects of natural disasters.
The authors of the study point to three core lessons. First, the U.S. needs greater transparency about where drugs are made and how much of the nation’s supply depends on specific facilities. Currently, there is little public information on production locations or capacity, leaving policymakers and patients unprepared when disasters disrupt manufacturing.
Second, diversification of the supply chain is essential. Over-reliance on a handful of facilities for critical medicines, as in the Baxter case, creates a fragile system where a single disruption can impact nationwide patient care.
Finally, with disasters increasing in frequency and severity, risk management must become a standard part of pharmaceutical operations. This includes disaster preparedness planning, redundant production capabilities, and strategies for rapid recovery after a disruption.
Implications for Patients and Industry
For patients, especially those reliant on essential or life-sustaining therapies, supply disruptions can have immediate and dangerous consequences. Hospitals and providers also face operational challenges when forced to ration supplies or switch to less familiar alternatives.
For industry, the findings underscore the need to proactively address vulnerabilities before regulatory or legislative mandates are imposed. As public attention to drug shortages grows, manufacturers may be expected to provide greater transparency about their disaster preparedness efforts and geographic risk exposure.
The Regulatory Context
The FDA has long monitored drug shortages and quality issues but often steps in only after a crisis emerges. This study suggests that regulatory agencies may need to take a more proactive role in assessing geographic risks and encouraging redundancy in supply chains. FEMA’s disaster declarations provide a starting point for identifying high-risk regions, but actionable strategies will require collaboration across federal, state, and private sectors.
Building a More Resilient Supply Chain
Ensuring that critical medicines remain available during disasters will require a mix of transparency, diversification, and preparedness. Policymakers, regulators, and manufacturers must work together to design strategies that mitigate the risks outlined in the study, from expanding domestic capacity to developing redundant manufacturing hubs.
At EMMA International, we specialize in helping life science companies strengthen resilience across their regulatory and operational systems. Whether supporting disaster risk management strategies, ensuring supply chain compliance, or preparing for FDA re-inspections following a disruption, EMMA International provides tailored expertise to help manufacturers protect patients and safeguard public health.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
Shazad, M., et al. (2025). Majority of pharmaceutical plants located in disaster-prone areas. JAMA.
