FDA stresses facility only responsible for 8% of total US hospital consumption for sterile injectable drug market, as well as the need for a reliable drug supply chain.
In a released statement, attributed to FDA Commissioner Robert M. Califf, MD, the agency is working closely with Pfizer to assess the impact of the damage at the pharma company’s Rocky Mount, North Carolina, facility.
The statement stressed that while Pfizer has one-third of the total sterile injectable drug market for hospitals in the U.S., the Rocky Mount facility only makes 25% of Pfizer’s total product for this market, not the entire market. This represents 8% of the total U.S. consumption is supplied by this site.
Within the next few days, the FDA will complete an assessment of products that may be impacted and the current available supply of those products. The FDA can’t provide a full list of products made at the facility based on disclosure laws, its initial analysis 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. Its assessment will also include what is stocked by wholesalers and distributors, if those companies are willing to share that information with the FDA.
The FDA does not expect there to be any immediate significant impacts on supply given the products are currently at hospitals and in the distribution system, but will work closely with partners in government, industry and the broader health care system to minimize impact on patient care. In addition, the FDA has initiated mitigation steps, such as looking for additional sources and asking other manufacturers to prepare to ramp up production, if needed, if those products are in shortage or at risk of shortage.
The statement also made note 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.
Reference: FDA Provides Update Regarding Storm Damage at Pfizer Facility in North Carolina. SILVER SPRING, Md., July 21, 2023. PRNewswire.
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