Update on Storm Damage to Pfizer Facility in North Carolina

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FDA released a press statement on July 21, 2023, to update the public on the damage to Pfizer’s facility at Rocky Mount, NC. “Importantly,” FDA wrote, “we do not expect there to be any immediate significant impacts on supply given the products are currently at hospitals and in the distribution system, but this is a dynamic situation and FDA staff are in frequent communication with Pfizer and other manufacturers.” FDA wrote it will work with its partners in government, industry, and the broader health care system to minimize impact on patient care.

As Pfizer has one third of the total sterile injectable drug market for US hospitals, and this facility produces 25% of Pfizer’s total product for this market, 8% of US consumption is supplied by this site. FDA’s analysis identified fewer than 10 drugs for which this plant is the sole source for the US market, but many of these are specific formulations that have substitutes available or where many weeks’ worth of stock should be housed in Pfizer’s other warehouses. For products produced at this facility that are in or may be at risk of shortage, FDA has started mitigating the impact on the market, through steps such as finding additional sources and asking other manufacturers to prepare to increase production.

To keep fair product distribution and maintain availability to those in most need, as well as to avoid hoarding, Pfizer has put strict allocation on the inventory of many of their products. This could impact localized suppliers depending on contractual relationships for supplies. FDA advised health care systems struggling to obtain specific drugs to contact their distributor or Pfizer directly.

“More broadly, this incident underscores that a robust, resilient, and safe drug supply chain is essential for public health and national security,” FDA wrote. The redundancy of manufacturing locations and suppliers is crucial to alleviate risks to supply that can occur from less predictable events such as natural disasters or geopolitical conflicts.

Source: FDA