The Hill Overnight Healthcare: NIH drug lab shut down
Last edited Mon Jun 8, 2015, 03:02 PM - Edit history (1)
The National Institutes of Health (NIH) was ordered to halt drug-making operations on Thursday after a federal investigation of a fungal contamination that potentially impacted 46 clinical studies.
So far, six patients may have been exposed to the contaminated drug and all are being monitored for symptoms. In all, 250 people are scheduled to participate in the studies, though the "vast majority" are not due for immediate treatment, the NIH said.
"This is a distressing and unacceptable situation," Dr. Francis Collins, director of the NIH, wrote in a release on Thursday, adding that the risk to patients is "deeply troubling."
The shutdown is the result of a weeks-long investigation by the Food and Drug Administration (FDA), which identified major "operational failures" ranging from inadequate quality control to insufficient employee training.
FDA inspectors pinpointed more than a dozen problems with the upkeep and practices of the NIH pharmacy. In a 14-page report, the FDA warned that the NIH's facilities are "not designed and controlled to prevent contamination risks to sterile drugs."
In one instance, inspectors saw an NIH staffer with exposed facial hair and skin on his wrists while he handled sterile drugs.
Another inspector found insects in several ceiling lights, as well as a lack of airflow throughout the building, and determined that NIH's facilities were not maintained in "clean and sanitary" conditions.
Read more here
http://thehill.com/policy/healthcare/244069-cruz-slams-obama-officials-for-refusing-to-testify
CORRECTED LINK via valerief
http://thehill.com/policy/healthcare/244078-nih-ordered-to-suspend-drug-making-facility-after-operational-failures
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