December 10, 2015

Statement on Remediation of the NIH Clinical Center Pharmaceutical Development Section

In June, NIH announced the closure of the sterile production unit of the Pharmaceutical Development Section (PDS) within the NIH Clinical Center due to serious problems with facilities, equipment, procedures, and training identified during a May 2015 U.S. Food and Drug Administration (FDA) inspection. Shortcomings were also found in the sterile portion of the Clinical Center Pharmacy, called the Intravenous Admixture Unit (IVAU), but these deficiencies were not deemed significant enough to stop operations. At NIH, we strive to hold ourselves to the highest standards and the revelation of these quality control issues has been deeply troubling. Our first responsibility always is to the safety and care of our patients, and anything less than exceptional quality is unacceptable.

I immediately appointed a high-level NIH Task Force co-led by NIH Principal Deputy Director Lawrence A. Tabak, D.D.S., Ph.D., and NIH Deputy Director for Science, Outreach, and Policy Kathy L. Hudson, Ph.D. Its charge was to monitor the status of protocols and research participants who received or were scheduled to receive PDS products for safety, identify alternative product sources to minimize research interruptions, work with FDA on corrective actions, and examine the root causes of the PDS and IVAU failures. One of the first actions the Task Force took was to contract with an external organization, Tunnell Consulting, to independently assess the PDS and IVAU and make recommendations for remediation.

NIH also took immediate steps to fix the issues in the IVAU, in regular consultation with FDA, to allow continued operations. These short-term remediation measures included retraining IVAU staff in proper aseptic techniques and appropriate procedures for hazardous drug preparation; improving the equipment cleaning procedure and tracking adherence to them; and implementing new procedures to control staff flow in and out of sterile areas. To ensure research participants who might benefit from experimental therapeutics receive them, NIH continues to consider the best options for prioritizing products, identifying NIH facilities for production, and seeking outside sources.

Today, my Advisory Committee to the Director (ACD) was briefed on all of the steps taken or underway to investigate and remediate the problems with the PDS. These assessments identified evidence of systemic and long-standing problems in the PDS, including overextended capacity, deficiencies in the physical facilities, personnel training, operations, and leadership and culture. With respect to the IVAU, reconstruction of facilities will ultimately be necessary for this unit to return to full operation.

In response to these findings, I will be establishing a new Office of Research Support and Compliance within the NIH Office of Intramural Research to improve the agency’s ability to maintain the highest levels of compliance with research regulations and standards. Furthermore, to ensure that NIH is getting the most rigorous and experienced advice possible about next steps, I am forming a new Clinical Center Working Group of the ACD, chaired by former Lockheed Martin CEO Norm Augustine. Its charge is to examine the structural and cultural issues and make recommendations to improve the organization, financing, and management of the NIH Clinical Center. This Working Group has extraordinary experience in managing complex clinical research organizations and will deliver its recommendations to the ACD in the spring of 2016.

NIH takes safety and compliance very seriously and we will continue to make every effort to ensure we have world class standards and practices in place at the NIH Clinical Center.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health