FDA Provides Update Regarding Storm Damage at Pfizer Facility in North Carolina

The following is attributed to FDA Commissioner Robert M. Califf, M.D.

SILVER SPRING, Md., July 21, 2023 /PRNewswire/ — The U.S. Food and Drug Administration is working closely with Pfizer to assess the impact of the damage at Pfizer’s Rocky Mount, North Carolina, facility. Over the next few days, we will complete a more extensive assessment of the products that may be impacted and the current available supply of those products. This assessment also will evaluate what is in Pfizer’s other warehouses and what is stocked by wholesalers and distributors, if those companies are willing to share that information with the FDA.

Importantly, 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. The FDA will work closely with partners in government, industry and the broader health care system to minimize impact on patient care.

Notably, while Pfizer has one third of the total sterile injectable drug market for hospitals in the U.S., and this facility only makes 25% of Pfizer‘s total product for this market – not the entire market. This means 8% of U.S. consumption is supplied by this site. While disclosure laws prevent the FDA from providing a complete list of products made at the facility, there is redundancy in the supply chain due to other manufacturers. Our initial analysis has identified less than 10 drugs for which Pfizer’s North Carolina plant is the sole source for the U.S. market, however, a number of these are specific formulations for which there should be substitutes or for which many weeks’ worth of stock should be available in Pfizer’s other warehouses.

For those products produced at this facility that are already in, or may be, at risk of shortage, the FDA has initiated mitigation steps, such as looking for additional sources and asking other manufacturers to prepare to ramp up production, if needed.

To have equitable distribution of the products and ensure availability to those in most need, as well as to avoid hoarding, Pfizer has put the inventory of many products on strict allocation. These allocation measures could lead to localized supply disruptions depending on contractual relationships for supplies. Health care systems that have trouble in obtaining a particular drug should contact their distributor or Pfizer directly.

We will share additional information as it becomes available.

More broadly, this incident underscores that a robust, resilient and safe drug supply chain is essential for public health and national security. Redundancy of manufacturing locations, which can include domestic locations, and of suppliers is important to mitigate risks to supply that can occur from natural disasters, geopolitical conflicts, or other less predictable events.

We remain committed to partnering across government, academia, and industry to strengthen and diversify the supply chain and ensure Americans continue to have access to drugs that are high quality, safe and effective.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.