FDA assessing supply impact of storm damage to Pfizer sterile injectables plant

The Food and Drug Administration said it did not expect “any immediate significant impacts on supply” after a tornado damaged a Pfizer plant in North Carolina that makes sterile injectables for U.S. hospitals, but is working with Pfizer to complete a more extensive assessment and will share more information as it becomes available.

The agency said its initial analysis has identified fewer than 10 drugs for which the plant is the sole source for the U.S. market, adding that “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.”

AHA is watching the situation closely because several of the drugs produced at the plant were on the FDA’s shortage list before the tornado struck.