NIH Suspends Operations at Pharmacy Section after Fungal Contamination Discovered

NIH's Director Francis Collins says he will oversee steps to remedy the situation

June 5, 2015 12:40 p.m.

The National Institutes of Health announced Thursday it suspended operations at its clinical center’s Pharmaceutical Development Section after two vials of injection drugs made at the Bethesda facility were found to have fungal contamination.

Six patients received injections made from the same batch in which the contaminated vials were found, according to NIH. The six patients are being “closely followed for any signs of infection,” NIH reported, although none of the patients had developed any symptoms or illness as of Thursday.

“This is a distressing and unacceptable situation,” NIH director Francis Collins said in a statement. “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 Section is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible.”

The Food and Drug Administration also reported finding multiple deficiencies in how the drug development lab was operating, according to a May 29 report. The report found the lab had flaws in its airflow system, a lack of proper disinfecting agents and poor quality control measures.

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The facility manufactures investigational drugs and vaccines as well as helps with studies and clinical trials of new and currently available drugs. Twenty staff members work in the unit, including pharmacists, chemists and technicians, according to NIH’s website.

Since the findings, NIH suspended operations at the center and is not planning to distribute any of the experimental drugs made there. The research center is bringing in an external group of experts in microbiology and sterile manufacturing practices to review the lab’s operations. NIH plans to issue a corrective action plan to the FDA by June 19.

In 2010, NIH officials held a ribbon cutting to dedicate a new facility for the Pharmaceutical Development Section. The new facility was designed to replace aging equipment and add a full-time quality assurance staffer to align with FDA’s “current manufacturing practices,” according to NIH’s website.

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