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Tuesday, April 19, 2016
Statement on Review of NIH Sterile Production Facilities
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.
In addition to the current review of facilities, last December the NIH Director formed a working group of his Advisory Committee to the Director (ACD) to evaluate and make recommendations about ways to enhance organization, financing, and management of the Clinical Center and its affilated labs and production facilities. The Clinical Center Working Group will deliver its report to the ACD this Thursday, April 21, from 4:00-6:00 p.m. ET.
Our patients remain our highest priority.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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