Today, the National Institutes of Health (NIH) was ordered to halt drug making operations after a fungal contamination potentially affected 46 clinical studies. In April, two vials of albumin, which is used for administration of the drug interleukin in experimental studies, were found to be contaminated with fungus. As it has been reported, vials from the same batch had been administered to six patients. The patients have been notified and are being monitored for the development of infection.
The FDA’s inspection report can be found here. It reads as a heavy indictment of the NIH facility. 17 specific observations are listed, describing the NIH’s lack of compliance with the government’s own standards. For example, FDA writes “an operator was observed processing sterile drug products with an exposed wrist from a gap between their gloves and their gown. The same operator had exposed facial hair.”
The Washington Post lists a number of other FDA concerns, including no filter or screen covering a vent into a laboratory “clean room.” Insufficient documentation about the cleaning of the facility. Insects found in a pair of ceiling light bays in clean rooms. Employees not wearing protective apparel. A water system that could harbor “microbial proliferation.” Inspectors found that the facilities themselves were “not designed and controlled to prevent contamination risks to sterile drugs.”
According to the NIH release, the following steps are being taken immediately to protect patients:
Operations of The Pharmaceutical Development Section have been suspended and no products will be made or distributed until all problems are fully understood and corrected. Materials produced by the Section are being systematically tested for contamination.
Of the participants in the 46 studies that are potentially affected, approximately 250 are currently scheduled to receive products manufactured by the PDS. NIH has notified the individual principal scientists responsible for each of those protocols, and is in the process of notifying the participants in these protocols. The vast majority of these patients are not immediately due for treatment and NIH is working to secure alternative sources for the products.
In addition to the immediate steps NIH is taking, it will provide an interim corrective action plan to the FDA by Friday, June 19, 2015.
“This is a distressing and unacceptable situation,” said NIH Director Francis S. Collins, M.D., Ph.D. “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. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible.”
Discussion
This event is reminiscent of the FDA’s New England Compounding Center inspection controversy. FDA’s inspectors observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination. In that case The U.S. Centers for Disease Control and Prevention (CDC) reported that 751 patients in 20 states were diagnosed with a fungal infection after receiving injections from the NECC. Of those 751 patients, the CDC reported that 64 patients in nine states died.
The closure is a good example just how difficult and costly it is to produce pharmaceutical grade products. Pharmaceutical and biologic manufacturing requires skill sets and often overtime commitments that don’t match government’s skills and experience. This serves as an example to academics and Pharmascolds that the government is not capable of doing everything and needs the pharmaceutical industry to do what they do best.
Francis Collins has to take responsibility for the mess. He announced he is personally overseeing this. But the best use of his time may be in finding alternative manufacturing then quickly returning to focus on developing cures. In the future NIH should consider contracting the manufacturing to facilities near NIH. Maryland has a robust Biotech Corridor which has extensive manufacturing experience and familiarity with FDA inspections and procedures.