NIH Drug Facility Suspended – Contamination Found
Details of the Suspension
On Thursday, June 4, the NIH announced that it would be suspending one of its drug facilities after a laboratory was discovered to have vials containing a fungal growth.
NIH officials discovered that two vials of albumin from a batch of drugs used for experimental reasons in early spring contained fungus, spurring a full out investigation of the laboratory that housed the vials.
Inspectors from the Food and Drug Administration (FDA) found the laboratory to be in violation of several operational regulations, resulting in its suspension.
Patients Received Drugs From Contaminated Batch
Six patients participating in experimental drug studies at NIH were administered samples from the batch containing the contamination, but after close monitoring by NIH officials, the patients were considered to be in decent health (no illnesses were unearthed).
NIH officials plan to take several corrective steps/actions to ameliorate the situation at hand.
The incident comes after an incident involving a U.S Military laboratory mistakenly sending live samples of anthrax to 51 laboratories in 17 states and three foreign countries and also in light of cases last year involving the Centers for Disease Control and Prevention (CDC) mishandling samples of anthrax and bird flu.
The recent incident is also very similar to an incident in 2012 where thousands of samples of steroids produced by the New England Compounding Center, intended for spinal injections, were found to be contaminated with fungal matter. The contaminated injections caused fungal infections, including meningitis, in approximately 751 patients, killing 64 of the patients.
Federal Inspectors Observe Other Violations
FDA inspectors who investigated the NIH laboratory this past week found that employees had also failed to wear protective coverings and clothing, which are important for keeping samples sterile.
They found important equipment in the lab to be deficient and virtually inoperable, and other non-clean issues were discovered during the inversitgation. The FDA plans to issue an interim corrective plan for NIH by June 19th.