NIH Temporarily Shuts Its Drug-Making Operation
Written by Editor   
Wednesday, June 17, 2015 04:30 PM
Quick Brief: The National Institutes of Health stops developing pharmaceuticals after “serious manufacturing problems” are found by the Food and Drug Administration.


The National Institutes of Health (NIH) has stopped operating its Pharmaceutical Development Section after discovering "serious manufacturing problems" leading to contamination of clinical drug lots, the agency announced.

The NIH also found that the section was not complying with standard operating procedures, the agency said in the announcement. The problems were discovered after the FDA received a complaint about the section and conducted inspections in mid-to-late May.

The drug development unit manufactures products for certain clinical research studies conducted in the NIH's hospital and at other facilities. "In April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination," the announcement explained. "Vials made from the same batch were administered to six patients, although it is unknown whether those or other vials were contaminated."

The six patients have been notified and are being monitored; none have become infected or ill so far, the agency said.

"This is a distressing and unacceptable situation," NIH Director Francis Collins, MD, PhD, said in the announcement. "The fact that patients may have been put in harm's way because of a failure to follow standard operating procedures ... is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible."

Problems uncovered during the FDA's inspections included flaws in the air handling system, inadequate quality control, and insufficient employee training, the agency said.

Specific operational problems included insufficient systems for cleaning and disinfecting certain areas of the facility, an employee with exposed skin and facial hair working with sterile drug products, and chemotherapy drugs being produced in an area that was not negatively pressured for containment, according to the inspection reports.

The NIH said it was taking several steps to protect patients:

  • Suspending operations of the section, with no products made or distributed until all problems are fully understood and corrected. Materials produced by the section are being systematically tested for contamination.
  • Notifying investigators and participants in 46 studies that were scheduled to receive products made by the section. The vast majority of the 250 patients involved are not immediately due for treatment; the NIH is looking for other sources for the products.
  • Appointing an external group of experts in microbiology and sterile manufacturing practices to conduct a thorough review, including an assessment of all standard operating procedures, policies, staffing, and training, and to make recommendations to the NIH director on the corrective actions required.

The agency also said it will provide an interim corrective action plan to the FDA.

The situation and the remedies being implemented point out the need to guard against complacency and to seek external oversight when necessary.  Even the NIH has realized they could do well with having an external group of experts to look at the processes.