Fungus found in NIH pharmaceuticals, manufacturing suspended

Following the FDA’s discovery of several deficiencies in manufacturing and operating procedures, the NIH has suspended operations of its Pharmaceutical Development Center until further notice, according to a press release.

“This is a distressing and unacceptable situation. 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,” NIH Director Francis S. Collins, MD, PhD, said in a press release.

Francis S. Collins

This is not the first time NIH’s Pharmaceutical Development Center (PDC), which produces products for various clinical research studies, has been in hot water. Back in April, two containers of albumin were found to have fungal contamination. The vials, which were used for the administration of interleukin in experimental studies, were administered to six patients. The patients have not yet developed any signs or symptoms, but are being monitored closely for any signs of infection.

In the FDA’s report, facility defects, including flaws in the air handling system, inadequate quality control, lack of employee training, and deficiencies in standard operating procedures, were all identified as problems during the inspection.

The NIH said that they are taking immediate action to ensure the protection of all patients. In addition to ceasing operations, all materials already produced will be systematically tested for contamination. Patients who are scheduled to receive products produced by PDS are in the process of being notified, and principal scientists responsible for clinical trials have been informed. Alternative treatment sources are currently being researched for these patients.

Thorough reviews will be conducted by experts in microbiology and sterile manufacturing procedures in order to offer corrective action plans to the NIH director.

The NIH has said they will provide an interim corrective action plan to the FDA by June 19, 2015.

“Our first responsibility is the safety and care of our patients. NIH leadership is determined to identify and correct all of the deficiencies that have led to this situation,” Collins said in the release.