The staff of the Pharmaceutical Development Section pose with their new capsule machine in the cleanroom (July 2013)

The staff of the Pharmaceutical Development Section pose with their new capsule machine in the cleanroom (July 2013)

It’s a scary day when even the federal government can’t keep a laboratory sterile for drug-making. Following the New England Compounding Center (NECC) fungal outbreak in 2012, the Food and Drug Administration (FDA) has shut down the government’s own compounding pharmacy run by the National Institutes of Health (NIH) over a failed quality inspection after six patients received vials of medication contaminated with fungus. The lab, called the Pharmaceutical Development Section – Clinical Center Pharmacy, is located in Bethesda, Maryland and primarily makes drugs used in government-sponsored clinical trials.

Thankfully, none of the six patients have shown any signs of fungal infection at this time. The drug at issue was albumin which is typically used for the administration of another drug called interleukin. Interleukin is commonly used in experimental studies for cancer. Several vials made from the tainted batch were administered to the six affected patients.

The FDA visited the laboratory on May 19 – 21 and May 26 and 29 and found the following violations (not a comprehensive list, please refer to the full inspection report):

  1. Protective apparel not worn as necessary to protect drug products from contamination
    1. Operators observed with exposed wrists and exposed facial hair
  2. Systems for maintaining equipment used to control aseptic conditions in the aseptic processing areas deficient
    1. The lab didn’t study air flow patterns in the ISO 5 hoods used to make sterile drugs.
  3. The system for cleaning and disinfecting the room and equipment in the aseptic processing areas to produce aseptic conditions were deficient
    1. Specifically, the lab didn’t use a sporicidal disinfection agent.
  4. The building was not maintained in a clean and sanitary condition.
    1. The inspectors found insects in the cleanroom light bays.

These were not the only deficiencies found at the NIH lab, but are among the most serious. As such, the NIH has taken the following steps to protect patients.

  1. “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.
  2. 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.
  3. An external group of experts in microbiology and sterile manufacturing practices will be appointed to conduct a thorough review, including an assessment of all standard operating procedures, policies, staffing, and training, and make recommendations to the NIH director on the corrective actions required.
  4. 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.”

Hopefully, this particular government lab can clean up its sterility protocols and begin producing safe and effective drugs for its patients without fear of fungal infection. Less importantly, we hope that the NIH will be able to rehabilitate its own image after this sour note in the agency’s history so that it can one day lead by example in the realm of patient safety. It is, after all, the federal government’s primary federal agency conducting important clinical research for the field of medicine.