Tags: national institutes of health | lab | shut | quality | failure

NIH's Drug Lab Shut Down After FDA Finds Quality Failures

Thursday, 04 Jun 2015 05:36 PM

A U.S.-run laboratory that makes drugs for the National Institutes of Health’s clinical trials failed a government quality inspection and will be temporarily shut down.

The U.S. Food and Drug Administration, the government regulator that spends much of its time making sure drug companies follow exacting quality standards, inspected the NIH’s Pharmaceutical Development Section last month. The lab makes drugs that are used in government-sponsored clinical trials at the NIH hospital in Bethesda, Maryland. Operations at the lab have been suspended.

Concerns were first raised in April, when two vials used for experiment studies were found to have fungal contamination. A subsequent FDA inspection in May found that the facility wasn’t completely sterile.

“This is a distressing and unacceptable situation,” Francis Collins, director of the NIH, said in the 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.”

The suspension comes after the U.S. Defense Department inadvertently sent samples that carried live anthrax, a deadly bacterium, to laboratories across the U.S. and potentially three foreign countries. While the health risk was minimal because the concentration of live spores was very low, U.S. officials said the experience raises questions about how the military handles anthrax while developing biological warfare countermeasures.

Lab Failures

At the NIH, FDA regulators said the clinic was “not designed and controlled to prevent contamination risks to sterile drugs,” according to the inspection report. FDA officials also noted an person with facial hair handling sterile drugs and wearing gloves that didn’t cover the wrists. Air flow and air pressure was also unequipped to keep drugs sterile.

Six patients received drugs that came from the fungus- contaminated vials. The NIH said that none is showing signs of illness. Along with monitoring the patients, the NIH is bringing in an outside group to investigate and make recommendations.

About 46 studies and 250 patients at the NIH hospital will be affected by the suspension, and the NIH is working on getting alternate sources for the drugs. The NIH said it will submit a plan for action to fix the shortfalls to FDA officials by June 19.


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A U.S.-run laboratory that makes drugs for the National Institutes of Health's clinical trials failed a government quality inspection and will be temporarily shut down.
national institutes of health, lab, shut, quality, failure
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2015-36-04
Thursday, 04 Jun 2015 05:36 PM
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