The FDA has addressed the impact of the recent devastating tornado that hit Pfizer’s Rocky Mount facility in North Carolina. While the agency acknowledged that the situation is still under investigation, they stated that they do not anticipate a significant disruption in the supply of drugs in the US.
FDA Commissioner Robert Califf mentioned that the proportion of the US market for sterile injectables supplied by the affected plant is lower than initially reported. Pfizer also confirmed that the majority of the damage occurred in the warehouse facility, where raw materials, packaging supplies, and finished medicines are stored. Thankfully, the initial assessment indicates that there isn’t extensive damage to the medicine production areas.
“Pfizer has one-third of the total sterile injectable drug market for hospitals in the US, and this facility only makes 25% of Pfizer’s total product for this market – not the entire market. This means 8% of US consumption is supplied by this site.”
– Robert Califf, FDA Commissioner
Although even an 8% reduction in the US supply of sterile injectables could be challenging, the FDA explained that Rocky Mount serves as the sole-source supplier for fewer than 10 drugs, and many of these have potential substitutes available or several weeks’ worth of stock in other Pfizer warehouses. The FDA is already actively seeking alternative suppliers or increasing production in other locations for these critical medicines.
“Pfizer is working diligently to move product to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies,” said the drugmaker, adding that it is also exploring alternative locations for production across its manufacturing network “in the US and internationally”.
Pfizer has taken measures to equitably allocate supplies to prevent hoarding, which could lead to localized supply disruptions. The facility in North Carolina plays a crucial role in producing essential medicines, including anesthetics, antibiotics, painkillers, and muscle relaxants used in surgeries. It employs around 3,200 individuals, all of whom are reported to be safe and accounted for. Pfizer operates nine other manufacturing plants in the US.
“Crews are working around the clock to restore power, assess the structural integrity of the building, and move finished medicines to nearby sites for storage.”
– Pfizer
