FDA Downplays Impact After Pfizer Tornado
An FDA update on tornado damage (see earlier story) at Pfizer’s Rocky Mount, NC sterile drug manufacturing facility says it does not expect any immediate impact on drug supplies because adequate inventories are currently at hospitals and in the distribution system. The agency says the facility supplies about “8% of U.S. consumption” of the sterile drug market, and there is “redundancy in the supply chain due to other manufacturers.” So far, FDA 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.”
The FDA update notes that for products made at the facility that are already in, or may be, at risk of shortage, it 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.”
Meanwhile, Pfizer says the site is closed while the damage is assessed. “Most of the damage was caused to the warehouse facility, which stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance,” a company release says. “Pfizer is working diligently to move product to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies. Pfizer is also exploring alternative manufacturing locations for production across our significant manufacturing presence in the U.S. and internationally and across the company’s partner network. After an initial assessment, there does not appear to be any major damage to the medicine production areas.”