Lab Issues Go Beyond The Really Nasty Bugs

Recently federal labs have come under scrutiny for failing to effectively control the quantities of nasty bugs like anthrax they have in stock.  Unfortunately, that is not the extent of the problems facing National Institutes of Health (NIH) facilities.

The NIH has closed its Pharmaceutical Development Section, which produces pharmaceutical drugs for its clinical trials (H/T Nature News).  After investigating a complaint, the Food and Drug Administration (FDA) found the Section failed to comply with standard operating procedures and had serious manufacturing problems.  The problems included finding fungal contamination and insects in manufacturing facilities, and insufficient dress for lab staff.

While the Section is closed, an external expert group will convene to conduct a thorough review.  Participants in clinical trials are being notified about the possible contamination of the drugs being tested, and some are requesting exemptions in order to continue taking the drugs.  The NIH has promised the FDA a corrective action plan by June 19.


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