dr Marty Makary discusses FDA approval of a new Alzheimer’s drug in The Evening Edit.
The commissioner for the US Food and Drug Administration said Friday that the agency does not anticipate any immediate significant supply impact after a tornado damaged a large Pfizer facility in North Carolina on Wednesday.
dr Robert Califf said in a statement shared on social media that it is working with the drugmaker to assess the impact of the Twister at the Rocky Mount plant, with a more detailed review of products that may be affected and the current availability of those products.
The assessment will also consider what is in Pfizer’s other warehouses and what is in stock from wholesalers and distributors, provided those companies are willing to share that information with the FDA.
“Importantly, as the products are currently in hospitals and in the distribution system, we do not anticipate any immediate significant supply impact, but this is a dynamic situation and FDA staff are in frequent communication with Pfizer and other manufacturers,” Califf said. “The FDA will work closely with partners in government, industry, and the wider healthcare system to minimize the impact on patient care.”
TORNADO DAMAGE AT PFIZER’S NORTH CAROLINA PLANT WILL RESULT IN LONG-TERM shortages of certain drugs, experts fear
dr Robert Califf speaks at an event celebrating the over-the-counter availability of hearing aids at a Walgreens in Washington, DC on October 19, 2022 (Photo by Nathan Posner/Anadolu Agency via Getty Images / Getty Images)
The FDA has identified fewer than 10 drugs for which the plant is the sole source for the U.S. market, but said a number of these are specific formulations for which substitutes should exist or should have many weeks’ worth of supplies at other Pfizer warehouses.
“For products manufactured at this facility that are already experiencing shortages or are at risk of shortages, the FDA has initiated remedial actions, such as seeking additional sources and asking other manufacturers to prepare for an increase in production if necessary,” Califf said, noting that Pfizer has subjected the inventor of many products to strict allocation to ensure fair distribution and availability and to avoid hoarding.
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The Pfizer facility on Wednesday, July 19, 2023, in Rocky Mount, NC after damage from severe weather. (Travis Long/The News & Observer via AP/AP Newsroom)
He warned that allocation measures could lead to localized supply disruptions depending on contractual relationships for supplies.
“More broadly, this incident underscores that a robust, resilient and secure drug supply chain is essential to public health and national security. The redundancy of manufacturing sites, which may include domestic sites, and of suppliers is important to mitigate supply risks that may arise from natural disasters, geopolitical conflicts or other unpredictable events,” said the Commissioner.
Pfizer has a third of the entire US hospital sterile injectables market, and Califf said the site accounts for 8% of US consumption.
The Pfizer facility was damaged after severe weather swept the area on Wednesday, July 19, 2023 in Rocky Mount, NC (WTVD via AP/AP Newsroom)
Experts feared that the Twister’s destruction would deal a severe blow to the already strained system.
The EF3 tornado landed near Rocky Mount and tore the roof of the Pfizer facility, though Pfizer said most of the damage was to the storage facility rather than drug manufacturing areas.
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The Pfizer facility was damaged after severe weather swept the area on Wednesday, July 19, 2023 in Rocky Mount, NC ((WTVD via AP) / AP Newsroom)
The maker of the COVID-19 vaccine said a warehouse for raw materials, packaging materials and finished medicines awaiting clearance suffered most of the damage and that all 3,200 workers on site are safe and will be held accountable.
The plant produces anesthetics and many other medicines needed for surgeries, but does not manufacture or stock the coronavirus vaccine or the Comirnaty and Paxlovid treatments.
dr Albert Bourla, Pfizer chairman and CEO, said employees are rushing the products to nearby locations where they will be stored and identifying sources to quickly replace raw materials lost in the incident. The pharmaceutical company says it is also looking at alternative manufacturing sites in its US network to fill production gaps, while the North Carolina site remains closed for repairs.
The Associated Press contributed to this report.