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NIH Suspends Operations in Its Pharmaceutical Development Section

Agency director announces ‘distressing and unacceptable situation’

The National Institutes of Health (NIH) Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) because of the discovery of serious manufacturing problems and the lack of compliance with standard operating procedures (SOPs). Upon receipt of a complaint, FDA representatives inspected the PDS between May 19 and May 29, and found deficiencies that will require the NIH Clinical Center to take corrective actions.

The facility makes products for clinical research studies conducted in the hospital and in collaborating facilities. In April, two vials of albumin, used for the administration of 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. At this time, none has developed signs of infection or illness.

“This is a distressing and unacceptable situation,” said NIH Director Francis S. Collins, MD, PhD. “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 to remedy the situation as swiftly as possible.”

Among the problems the FDA identified in their 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 the lack of compliance with SOPs. Deficiencies were also identified in the Clinical Center Pharmacy.

According to the NIH, the following steps are being taken immediately to protect patients:

  • Operations of the Pharmaceutical Development Section have been suspended, and no products will be made or distributed until all of the problems are fully understood and corrected. Materials produced by the section are being systematically tested for contamination.
  • Of the participants in the 46 studies that are potentially affected, approximately 250 are currently scheduled to receive products manufactured by the PDS. The NIH has notified the individual principal scientists responsible for each of those protocols, and is in the process of notifying the participants in the protocols. Most of the patients are not immediately due for treatment, and the NIH is working to secure alternative sources for the products.
  • An external group of experts in microbiology and sterile manufacturing practices will be appointed to conduct a review, including an assessment of all SOPs, policies, staffing, and training, and to make recommendations to the NIH director on the corrective actions required.
  • In addition to the immediate steps the NIH is taking, it will provide an interim corrective action plan to the FDA by June 19.

Source: NIH; June 4, 2015.

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