Supply impact of Pfizer’s tornado-hit plant less than feared
The FDA said it does not expect the damage to Pfizer’s Rocky Mount facility caused by a massive tornado on Wednesday will have a big impact on the supply of drugs in the US, but added the situation remains under investigation.
In the agency’s first public statement on the disaster, FDA Commissioner Robert Califf said that the proportion of the US market for sterile injectables supplied by the plant is considerably lower than first reported.
“Pfizer has one-third of the total sterile injectable drug market for hospitals in the US, and this facility only makes 25% of Pfizer’s total product for this market – not the entire market,” he said. “This means 8% of US consumption is supplied by this site.”
Moreover, Pfizer said that most of the damage was caused to Rocky Mount’s warehouse facility, which stores raw materials, packaging supplies, and finished medicines, and an initial assessment has indicated there is not too much damage to medicine production areas.
“Pfizer is working diligently to move product to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies,” said the drugmaker, adding that it is also exploring alternative locations for production across its manufacturing network “in the US and internationally”.
Even an 8% hit to the US supply of sterile injectables would be challenging, but the FDA said its initial analysis is that Rocky Mount is the sole-source supplier for fewer than 10 drugs and several 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 said it has already started the process of seeking alternative suppliers or ramping up production elsewhere for these medicines. Pfizer, meanwhile, has already implemented measures to allocate supplies equitably to prevent hoarding, which could lead to some localised supply disruptions, said the regulator.
The North Carolina facility produces critical medicines like anaesthetics, antibiotics, painkillers, and muscle relaxants used in surgeries. It employs around 3,200 people who are “safe and accounted for,” according to Pfizer, which operates nine other manufacturing plants in the US.
“Crews are working around the clock to restore power, assess the structural integrity of the building, and move finished medicines to nearby sites for storage,” said the company.
The EF3-strength tornado generated winds that peaked at more than 150 miles per hour, resulting in at least 16 people being injured, two seriously.