The National Institutes of Health has halted operations at one of its drug manufacturing facilities after fungus was discovered in two vials of a blood protein, according to officials on Thursday.
Contaminated vials of the blood protein albumin were discovered in April after a complaint was made to the Food and Drug Administration. The vials were made from a batch that was eventually given to six patients, although it is not known whether any of those vials were contaminated. Officials said none of the patients have shown signs of infection or illness, and all have been notified and are being monitored.
Problems were discovered during an FDA inspection of the NIH Clinical Center's Pharmaceutical Development Section between May 19 and May 29. Investigators found a number of what the NIH described as “serious manufacturing problems,” including failures to follow standard operating procedures. Among the problems discovered during FDA's inspection were flaws in the air handling system, inadequate quality control, and insufficient employee training.
“This is a distressing and unacceptable situation,” said NIH Director Dr. Francis Collins in a statement released Thursday. “The fact that patients may have been put in harm's way because of a failure to follow standard operating procedures in the NIH Clinical Center's Pharmaceutical Development Section is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible.”
The facility produces drug products used in clinical research studies in the hospital and collaborating facilities. The contaminated albumin was produced to administer the drug interleukin for experimental study.
Participants in as many as 46 studies are potentially affected, according to officials, with approximately 250 scheduled to receive products from the facility. Officials have yet to estimate when the facility might resume operations. While it is closed, no products will be made or distributed from the facility until all problems have been identified and corrected, officials said.
In addition, the agency said it will appoint an outside group of experts to review and assess operating procedures and recommend any needed corrective measures.
The NIH is scheduled to submit a plan to the FDA by June 19 that highlights the actions taken to address the issues discovered at the facility.
“Our first responsibility is the safety and care of our patients,” Collins said. “NIH leadership is determined to identify and correct all of the deficiencies that have led to this situation.”
