A pharmacy at the National Institutes of Health, a key component in ongoing scientific studies, was closed after fungi was found in drugs manufactured there, according to federal authorities.
The Pharmaceutical Development Section suspended work, it was announced by the NIH on Thursday, after two inspections in May of the facility in Bethesda, Md., found violations, according to an announcement.
The fungal contamination was found in two vials of albumin, used in administration of cancer drug interleukin, in April. Vials from the same batch were used to treat six patients – all of whom are being monitored, but none of whom have been sickened, according to the NIH.
“This is a distressing and unacceptable situation,” said Francis Collins, the director of the NIH, 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 Development Section is deeply troubling.”
Collins will “personally oversee” the fixes, he added.
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Violations found by the FDA at inspections on May 19 and May 29 included flaws in the air-handling system, inadequate quality control, lack of training and non-compliance with standard operating procedures, according to the inspection report.
“Our first responsibility is the safety and care of our patients,” said Collins.
Forty-six studies are going to be affected by the closure of the pharmacy, the NIH said. About 250 patients who are undergoing trials are going to be switched to drugs from other facilities, they added.
Filed Under: Drug Discovery
