In light of serious problems identified in the NIH Clinical Center Pharmaceutical Development Section last year, NIH launched a multifaceted effort to ensure that processes for patient safety and quality of care at the hospital are of the highest standards. Accordingly, NIH hired two companies specializing in quality assurance for manufacturing and compounding — Working Buildings and Clinical IQ — to evaluate all of its facilities producing sterile or infused products for administration to research participants.
This evaluation is underway and preliminary findings have identified facilities not in compliance with quality and safety standards, and not suitable for the production of sterile or infused products. As a result, production has been suspended in two facilities: a National Cancer Institute laboratory engaged in cell therapy production and a National Institute of Mental Health facility producing positron emission tomography (PET) materials.
There is no evidence that any patients have been harmed, but a rigorous clinical review will be undertaken. NIH will not enroll new patients in affected trials until the issues are resolved.