The move follows the discovery of serious manufacturing problems and lack of compliance with standard operating procedures
The National Institutes of Health (NIH) Clinical Center in the US has suspended operations of its Pharmaceutical Development Section (PDS) due to the discovery of serious manufacturing problems and lack of compliance with standard operating procedures. NIH is the nation's medical research agency and is part of the US Department of Health and Human Services.
Upon receipt of a complaint, US Food and Drug Administration (FDA) representatives inspected the Pharmaceutical Development Section (PDS) in May and found a series of deficiencies that will require a number of corrective actions.
The facility makes products for certain clinical research studies conducted in the hospital and collaborating facilities. 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 it is unknown whether those or other vials were contaminated. The six patients have been notified and are being followed closely for any signs of infection.
‘This is a distressing and unacceptable situation,’ said NIH Director Dr Francis Collins. ‘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 its inspection were deficiencies in the physical facility, including flaws in the air handling system, and operational failures including inadequate quality control, insufficient employee training and lack of compliance with standard operating procedures. Deficiencies of lesser significance were identified in the Clinical Center Pharmacy. The FDA inspection reports are available here.
The following steps are being taken immediately to protect patients:
In addition to the immediate steps NIH is taking, it will provide an interim corrective action plan to the FDA by Friday 19 June. ‘Our first responsibility is the safety and care of our patients,’ said Dr Collins. ‘NIH leadership is determined to identify and correct all of the deficiencies that have led to this situation.’