FDA Puts NIH’s Pharmaceutical Development Section on Hold

The National Institutes of Health (NIH) Clinical Center suspended operations of its Pharmaceutical Development Section (PDS) following the discovery of serious manufacturing problems and lack of compliance with standard operating procedures.

NIH clinical center

NIH clinical center

A June 4 press release explained that, upon receipt of a complaint, the US Food and Drug Administration (FDA) inspected the PDS between May 19 and May 29. They found a series of deficiencies that require the NIH Clinical Center to take corrective actions.

The PDS makes products for clinical research studies conducted in the hospital and collaborating facilities.

In April, 2 vials of albumin, used for the administration of interleukin in studies, were found to have fungal contamination. Vials made from the same batch were administered to 6 patients, although it is not clear whether those or other vials were contaminated. The 6 patients have been notified and are being followed for signs of infection, although so far, none have developed signs of infection or illness.

“This is a distressing and unacceptable situation,” NIH Director Francis S. Collins said in the press release. He said that putting patients in harm’s way because of a failure to follow standard operating procedures at the NIH is deeply troubling.” I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible,” he added.

The FDA also identified deficiencies in the physical facility, including flaws in the air handling system, and operational failures including inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures.

The New York Times wrote that the findings added to a series of mistakes with potentially lethal substances in government laboratories. The US Department of Defense said on June 3 that it had mistakenly sent suspected live samples of anthrax to at least 51 laboratories in 17 states and 3 other countries. Last July, vials of smallpox and other infectious agents were discovered in a lab at the NIH after being stored and apparently forgotten for decades.

The NIH announced that it is taking immediate steps to protect patients, including suspending operations of the PDS—no products will be made or distributed until all problems are fully understood and corrected. Materials produced by the PDS are being systematically tested for contamination.

As many as 46 NIH studies could be affected by the PDS shutdown; approximately 250 patients were scheduled to receive products manufactured by the PDS. The NIH has notified the individual principal scientists responsible for each of those protocols, and is in the process of notifying the participants.

The NIH says that most of these patients are not immediately due for treatment and that it is working to find alternative sources for the products.

An external group of experts in microbiology and sterile manufacturing practices will be appointed to conduct a thorough review of the PDS and assess all standard operating procedures, policies, staffing, and training, and make recommendations to the NIH director on the corrective actions required.

The NIH says it will provide an interim corrective action plan to the FDA by June 19, 2015.

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