Pfizer, FDA work to ease shortage concerns as tornado relief efforts pick up at North Carolina injectables plant

Pfizer and the U.S. FDA are picking up the pieces after a violent tornado devastated the drugmaker’s massive North Carolina injectables plant last week.

Pfizer on Friday said it kicked off “immediate efforts” to provide relief and repair to the damage caused to its manufacturing facility in Rocky Mount, North Carolina. It noted crews are working around the clock to restore power, assess the structural integrity of the building and to relocate finished medicines to nearby sites for storage.

In the meantime, the site—which Pfizer notes plays a “critical role” in the U.S. healthcare system—will be closed. Most of the damage occurred at the site’s warehouse facility, which stores raw materials, packaging supplies and finished medicines awaiting release by quality assurance, Pfizer said.

The company said it’s working diligently to move products to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies.

The drugmaker also said it’s looking at moving production of certain drugs to other sites in its global manufacturing network while recovery efforts progress.

“After an initial assessment, there does not appear to be any major damage to the medicine production areas,” Pfizer said in a press release.

Pfizer is also working directly with customers in the wake of the Rocky Mount tornado. In a letter sent to hospitals, the pharma company outlined a subset of products made at the plant that “may experience continued or new supply disruptions in the near-term.”

The drugmaker identified those products based market share and inventory levels of less than 3 months across its distribution centers and the wholesale chain.  The 3-month inventory threshold represents “an abundance of caution based on the information available today” and should not be taken as an indication of estimated production restarts," the company said.

The same day Pfizer issued its release, the FDA confirmed it’s working in tandem with the company to right the ship at Rocky Mount and mitigate any potential medicine shortfalls.

Importantly, the drug regulator stressed that it does not expect the disaster to cause any immediate significant impacts on supply, given that most of the products affected are currently at hospitals and in the distribution system.

Pfizer reiterated Friday that all 3,200 local staffers that report to the production site are safe and accounted for thanks to the site’s long-standing evacuation plan.

Last week’s tornado traveled some 16.5 miles on the ground, lasting for about 30 minutes with wind speeds up to 150 miles per hour, according to the National Weather Service.

Recognizing the sweeping effects of the natural disaster, Pfizer said it has cleared a donation to the American Red Cross North Carolina Chapter and the United Way Tar River Region to support relief and recovery needs in the area. Further, the Pfizer Foundation is matching employee donations to these organizations.

As for the Rocky Mount site’s role in the greater U.S. healthcare ecosystem, Pfizer plant is responsible for producing nearly 25% of all the company’s sterile injectables, which include anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers. That in turn represents some 8% of all the sterile injectables used in U.S. hospitals. Aside from Rocky Mount, Pfizer operates another 10 manufacturing sites in the U.S.

The FDA said it will spend the next few days working up an assessment of the drugs that could be affected, plus the current availability of those products. The review will also evaluate current stock in Pfizer’s other warehouses and inventories at wholesalers and distributors.

When it comes to products from the facility that are already in or may be at risk of shortage, the FDA says it’s teed off mitigation steps like looking for additional sources and asking other manufacturers to prepare to ramp up production, if needed.

Further, in order to keep distribution equitable and prevent hoarding, the FDA said Pfizer has put the inventory of many of the affected products on “strict allocation.”

“These allocation measures could lead to localized supply disruptions depending on contractual relationships for supplies,” the FDA said in its release, adding that “[h]ealth care systems that have trouble in obtaining a particular drug should contact their distributor or Pfizer directly.”

While resilient buildings, pharma manufacturing plants sometimes come under the devastating forces of Mother Nature. In 2017, Hurricane Maria briefly idled much of the industry's production sites in Puerto Rico as companies evaluated the toll from the storm.

Editor's note: This story has been updated with additional information from Pfizer's letter to hospital customers.