NIH Halts Experimental Drug Studies Due to Contamination
The National Institutes of Health (NIH) has decided to halt its production program of experimental drugs for their research studies after discovering that two vials contained fungus and some manufacturing problems.
Details of the Contamination
The suspension of the experimental program leaves about 250 people in approximately 46 NIH studies awaiting word back for when they will proceed with any further experimentation.
NIH employees discovered the fungal growth in vials of albumin, which are used to administer the drug interleukin, back in April. Though about 600 other vials of the same product appeared to be fine, an investigation and additional testing was launched concerning the issue.
The laboratory where the vials were kept was investigated after a complaint was filed to the Food and Drug Association. Upon arrival, inspectors noted that the laboratory contained flaws in air flow, inadequate quality control and lack of compliance with standard operating procedures.
NIH Releases Statement
NIH Director Francis Collins released a statement voicing his views on the issue, referring to the situation as “distressing and unacceptable.” NIH employees are expected to comply with standard procedures to insure that products are kept sterile at all times.
On Thursday, June 4th, NIH announced that no products will be manufactured or distributed until after additional testing has taken place and the existing problems have been corrected. Outside experts are expected to be appointed by the institutes to administer extra review.