FDA Hopes to Stem Possible Drug Shortages After Tornado Damages Pfizer Plant

FDA Commissioner Dr. Robert M. Califf said the agency has started taking steps to try to head off potential drug shortages stemming from a tornado ripped through a Pfizer manufacturing plant in North Carolina last week. 

Fresh off a tour of the damaged facility Friday, Califf said the FDA is working closely with Pfizer to assess and minimize supply disruptions as well as any impact on patients. 

“In the past week, we began an assessment of products that may be impacted and their available supply,” Califf said over Twitter. “For products made at this facility that are already in, or may be at risk of shortage, FDA has initiated steps to help to mitigate supply issues.”

Most of the damage occurred in the plant’s warehouse facility which stored raw materials, packaging supplies and finished medicines awaiting quality control inspection, according to a statement from Pfizer. 

Pfizer has put the inventory of many drugs on strict allocation to ensure equitable distribution and avoid hoarding, the FDA said in a statement last week.  

“These allocation measures could lead to localized supply disruptions depending on contractual relationships for supplies,” the agency said. 

The Rocky Mount plant produces almost 25% of Pfizer’s sterile injectables such as anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers — making up about 8% of the sterile injectables in the U.S., according to the company. 

Initial assessments found less than 10 drugs that are solely sourced in the U.S. at Pfizer’s North Carolina plant. 

For drugs at risk of shortage, the FDA is already looking for alternative sources and asking other manufacturers to increase production, if needed.