- After the FDA found fungus-contaminated material at an NIH facility, the center shut down production of drugs used in 46 clinical trials.
- Specifically, two months ago, two vials of albumin, which were used for administering interleukin in studies, were found to be contaminated with fungus.
- According to the NIH, the vials were administered to six patients, who have been notified and are being watched closely.
When it comes to shutting down pharmaceutical testing and manufacturing facilities that are not in compliance with quality-control standards, the FDA is an equal-opportunity regulator. Whether it's India, or Bethesda, MD, the FDA's job is to put the kibosh on any situation which threatens patient safety. In this case, the quality-control problems at the NIH facility evoked outrage among FDA officials.
As outlined in the FDA report, there are numerous problems with the NIH facility, including the fact that the facility was not designed to prevent contamination risks to sterile drugs; flaws in the ventilation system; deficient systems for maintaining equipment used to control aseptic conditions; and other problems.
NIH director Dr. Francis Collins has vowed to personally oversee remediating the situation in a stepwise, comprehensive, and rapid fashion.