Pharmaceutical manufacturer Pfizer Inc.
PFE,
said Friday that most of the damage from Wednesday’s tornado that ripped through its Rocky Mount, N.C., manufacturing facility was to a warehouse area storing finished drugs, raw materials and packaging supplies.
The 1.4-million-square-foot facility, which produces nearly 8% of all sterile injectable medicines used in U.S. hospitals, remains closed while the damage is assessed, Pfizer said in a release. Those drugs include anesthesia, drugs for treating infections, and other injections that are critical to the care provided in emergency rooms, intensive care units and other settings.
The Food and Drug Administration issued a response Friday evening, saying it does not expect there to be any “immediate significant impacts on supply…” because of the amount of products already in the supply chain or in hospitals.
“Notably, while Pfizer has one third of the total sterile injectable drug market for hospitals in the U.S., and this facility only makes 25% of Pfizer’s total product for this market – not the entire market,” the FDA said.
Crews are working around the clock to restore power, assess the building’s structural integrity and move the finished drugs to alternative sites for storage, the pharmaceutical giant said. Pfizer said it is also looking for sources to replace damaged raw materials and supplies and alternative manufacturing locations for production. “After an initial assessment, there does not appear to be any major damage to the medicine production areas,” the release said.
“A great deal of work needs to be done, but I assure everyone, most importantly the people of the Rocky Mount community, that we will put Pfizer’s full power behind this effort,” Pfizer CEO Albert Bourla said in a statement. More than 3,000 Pfizer employees work at the site, and all are safe, the company said.
The damage from the tornado, which carried peak winds of 150 mph, has raised concerns among drug-supply experts that the disaster could worsen existing shortages of sterile injectables. Many sterile injectables are generic, minimally profitable products, yet they’re also complex to manufacture and leave little room for error because they’re often injected directly into the bloodstream. Those factors have contributed to widespread shortages of these key medicines, drug-supply experts say.
More than 40% of the new drug shortages this year are injectable medicines, according to the University of Utah Drug Information Service. Nearly half of the more than 500 products listed on a recent Pfizer injectables availability report were depleted or in limited supply.
Policy changes are needed to address persistent shortages of these drugs, given their central role in hospital care, experts say. A late June report from researchers at the Brookings Institution proposed incentives to improve the manufacturing infrastructure for generic sterile injectables and reward hospitals for proactively addressing shortages of these drugs as well as a government-funded buffer inventory of certain key injectables to protect against shocks to the supply chain.
Pfizer said it is working with the U.S. Food and Drug Administration and other federal, state and local officials to fully restore function to the Rocky Mount site, which produced nearly a quarter of all Pfizer sterile injectables.
The FDA is aware of the storm damage, the agency’s commissioner Dr. Robert Califf said in a tweet Thursday, adding that he had spoken with Bourla to offer support and understand the extent of the damage and any potential impact to the drug supply. “We’re following the situation closely,” Califf wrote. The FDA said Friday that it had no other comments on the situation.
Pfizer said it is also donating to local units of the American Red Cross and United Way to support relief and recovery efforts.
Pfizer stock was up 1.7% on Friday and has declined 27% in the year to date, while the S&P 500
SPX,
has gained 18%.
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