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 Vials made from the same batch of albumin had been administered to
six patients, though it is not known if those were also
contaminated, the agency said. The six patients are being monitored
and no signs of infection or illness have emerged.
Inspectors from the U.S. Food and Drug Administration (FDA)
identified operational failures at the facility, including
inadequate employee training and quality control.
The albumin was being used for the administration of the drug
interleukin in clinical trials.
"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,"
NIH Director Dr. Francis Collins said in a statement, calling the
situation "distressing and unacceptable."
The NIH said it will have to take several corrective actions,
including appointing an external group of experts in microbiology
and sterile manufacturing practices to review all standard operating
procedures, policies, staffing and training.
An interim corrective action plan will be provided to the FDA by
June 19, the NIH said.
The problem at the NIH comes on the heels of a U.S. military
laboratory inadvertently shipping samples of live anthrax to 51
laboratories in 17 states and three foreign countries, and cases
last year in which the Centers for Disease Control and Prevention
(CDC) mishandled samples of anthrax and bird flu.
It also echoes a 2012 episode in which thousands of doses of
steroids intended for spinal injections and produced by the New
England Compounding Center were found to be contaminated with fungal
matter. The tainted injections caused fungal infections, including
meningitis, in 751 patients and killed 64, according to CDC.
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According to the report of the FDA inspectors, some NIH workers
failed to wear protective clothing intended to keep drug samples
sterile. One had "an exposed wrist from a gap between their gloves
and gown" as well as "exposed facial hair."
Equipment meant to keep contaminants out of the area where workers
processed drugs was "deficient," the inspector found. For instance,
no filter or screen covers a vent that connects the cleanroom to the
roof 14 floors above.
(Reporting by Michele Gershberg and Bill Berkrot in New York;
Editing by Tom Brown and David Gregorio)
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