The Food and Drug Administration (FDA) has released an update regarding the impact of a recent tornado on a Pfizer manufacturing facility located in North Carolina. Despite extensive damage sustained by the facility, the FDA assures that there will be no immediate significant effect on the supply of drugs produced there.
Currently, the drugs manufactured at the facility are readily available at hospitals or within the distribution system. It is important to note that while Pfizer holds one-third of the total sterile injectable drug market for hospitals in the U.S., the affected facility accounts for only 25% of Pfizer’s overall supply of this particular product.
After conducting an initial analysis, the FDA has identified less than 10 drugs for which the damaged plant is the sole source in the U.S. market. However, the FDA also emphasizes that many of these drugs have alternative formulations, and there should either be substitutes or a significant stock available in other Pfizer warehouses for several weeks.
To mitigate any potential shortages, the FDA has proactively taken steps such as seeking additional sources and reaching out to other manufacturers to prepare for increased production of the products that are currently or may be at risk due to the situation at Pfizer’s North Carolina facility.
Pfizer has reported that a majority of the tornado damage to its Rocky Mount, N.C. manufacturing plant primarily impacted the warehouse facility, which stores raw materials, packaging materials, and finished medicines awaiting shipment. Fortunately, the production areas of the plant were unaffected. Pfizer is now in the process of relocating and storing medicines in alternative locations, replacing damaged supplies, and transferring manufacturing operations to other facilities.