The National Plan to Address the Pfizer Plant Tornado Damage

July 24, 2023

The FDA said it does not expect there to be immediate significant impact to the U.S. drug supply stemming from the recent tornado damage at Pfizer’s Rocky Mount, North Carolina facility.

On Friday, the federal agency said it was working closely with the manufacturer to assess the potential scope of challenges related to the July 19 EF3 tornado. The FDA said it didn’t expect immediate impact because there was “redundancy in the supply chain due to other manufacturers” for most of the facility’s products.

“We remain committed to partnering across government, academia, and industry to strengthen and diversify the supply chain and ensure Americans continue to have access to drugs that are high quality, safe and effective,” FDA Commissioner Robert M. Califf, MD, MACC, said in a statement.

Here’s what you need to know:

• Background:  Pfizer has about a third of the total sterile injectable drug market for hospitals in the U.S., and the Rocky Mount facility makes 25 percent of Pfizer’s total product for this market.
  • About 8 percent of U.S. injectable drug market is supplied by this site.
• By product:  The facility’s production includes Pfizer’s sterile injectables—including anesthesia, analgesia, therapeutics, anti-infectives, and neuromuscular blockers, company officials said.
• Damaged areas:  The facility remains closed as the company assesses the situation. The warehouse facility sustained the majority of the damage, while there does not appear to be any major damage to the medicine production areas. The company is conducting an assessment of alternative production strategies for the rest of its U.S. and international manufacturing.
• Next steps:  The FDA said there were less than 10 products “for which Pfizer’s North Carolina plant is the sole source,” but many of these products are specific formulations or are in stock at other Pfizer warehouses for several weeks.
  • The company has put certain products on strict allocation, while the FDA has begun looking for additional sources and asking manufacturers to prepare to ramp up production, if needed.
• Quotable:  “More broadly, this incident underscores that a robust, resilient and safe drug supply chain is essential for public health and national security,” the FDA said in a statement. “Redundancy of manufacturing locations, which can include domestic locations, and of suppliers is important to mitigate risks to supply that can occur from natural disasters, geopolitical conflicts, or other less predictable events.”

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

Statements from Pfizer and the FDA are available online. HAP continues to monitor the latest emergency management implications from the Pfizer facility damage. HAP members can read a member-only resource focused on the potential preparedness strategies to consider following the storm.