FDA Eases Fears of Major Drug Shortages After Tornado Damages Pfizer Facility

Last week’s tornado in North Carolina should not cause too much of an immediate disruption in the supply of drugs manufactured at a Rocky Mount, North Carolina plant operated by Pfizer, FDA officials said.

“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,” FDA Commissioner Robert Califf, MD, said in a statement Friday. “The FDA will work closely with partners in government, industry, and the broader healthcare system to minimize impact on patient care.”

The tornado swept through the area on Wednesday. The Pfizer facility there — one of 10 Pfizer manufacturing sites in the U.S. — has been a key producer of sterile injectables since 1968, the company noted in a press release. The site, which is closed while damage is assessed, is currently responsible for manufacturing nearly 25% of all Pfizer’s sterile injectables, including anesthesia, analgesia, therapeutics, anti-infectives, and neuromuscular blockers. This amounts to nearly 8% of all the sterile injectables used in U.S. hospitals.

Califf said his agency would “complete a more extensive assessment of the products that may be impacted and the current available supply of those products” over the next few days. “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.”

“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,” the commissioner said. “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,” he added.

Pfizer said in its release that all 3,200 workers at the site “are safe and accounted for after excellent implementation of the site’s long-standing evacuation plan” and that most of the tornado damage “was caused to the warehouse facility, which stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance. 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,” the release said. “After an initial assessment, there does not appear to be any major damage to the medicine production areas.”

To make sure the current supplies are distributed equitably and keep them as available as possible — as well as to avoid hoarding — “Pfizer has put the inventory of many products on strict allocation,” FDA’s 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.”

To help with local relief efforts, “Pfizer also announced a donation to the American Red Cross North Carolina Chapter and United Way Tar River Region,” the Pfizer press release added. “Additionally, the Pfizer Foundation will match employee donations to these organizations.”