Tornado hits Pfizer production facility in NC

Last Wednesday, a tornado swept through the Rocky Mount, North Carolina, area, where one of Pfizer's 10 U.S. manufacturing sites is located. The tornado hit the facility and destroyed the site's warehouse, which contained raw materials, packaging supplies, and finished medicines.

According to Pfizer, its North Carolina facility currently manufactures around 25% of its sterile injectables, including anesthesia, analgesia, therapeutics, anti-infectives, and neuromuscular blockers. These drugs make up almost 8% of all sterile injectables used in U.S. hospitals.

In a letter sent to hospital customers, Pfizer noted that around 64 different formulations of more than 30 drugs could see "continued or new supply disruptions in the near-term." The affected drugs included pain relievers like fentanyl and morphine, lidocaine for local anesthesia, and heparin, which is used to treat or prevent blood clots.

Currently, Pfizer said it is "is working diligently to move product to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies" and "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."

How this will impact drug shortages

After the tornado, FDA officials also went to visit the facility and assess how the damage could potentially impact current drug supplies nationwide.

After the assessment, FDA Commissioner Robert Califf said the agency 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 noted that it was a "dynamic situation and FDA staff are in frequent communication with Pfizer and other manufacturers."

According to Califf, FDA's 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.

Over the next few days, Califf said FDA plans to "complete a more extensive assessment of the products that may be impacted and the current available supply of those products." The agency will also evaluate the current supply of drugs in Pfizer's other warehouses, as well as what is available from wholesalers and distributors, if possible.

To ensure that current supplies are available and distributed equitable, "Pfizer has put the inventory of many products on strict allocation," Califf said. "These allocation measures could lead to localized supply disruptions depending on contractual relationships for supplies. Healthcare systems that have trouble in obtaining a particular drug should contact their distributor or Pfizer directly."

According to Michael Ganio, senior director of pharmacy practice and quality for the American Society of Health-System Pharmacists, many of the drugs impacted by the tornado damage are already facing shortages, and hospitals likely have plans in place to address any supply issues.

"It's very likely hospitals and health systems have already begun managing those shortages or have strategies in place to manage them," he said. "So hopefully, there will be minimal impact." (Jewett, New York Times, 7/25; Reuters, 7/24; Frieden, MedPage Today, 7/24; Jeong, Washington Post, 7/25)

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