Following an inspection of the PDS between May 19 and May 29, FDA officials uncovered a series of deficiencies that will require the NIH Clinical Center to take a number of corrective actions.
The FDA found that in April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination. Vials made from the same batch were administered to six patients, although the NIH says it is unknown whether those or other vials were contaminated. The six patients are being followed closely for any signs of infection, though the NIH says that at present, none has developed signs of infection or illness.
The inspectors also revealed that some chemotherapies produced by PDS were made in an area that is not negatively pressured for containment.
“This is a distressing and unacceptable situation,” NIH Director Francis Collins said in a statement. “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.”
Among the problems the FDA identified in their inspection and unveiled in the Form 483, were deficiencies in the physical facility, including flaws in the air handling system, and issues with inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures.
The NIH said it’s taking a number of steps to protect patients, including through the creation of an external group of microbiology and sterile manufacturing experts that will review the operating procedures of PDS, as well as working to secure alternative ways to manufacture products for about 250 patients scheduled to receive drugs made from the center.
In addition, NIH will provide an interim corrective action plan to the FDA by June 19.