U.S. gov't agency suspends drug production after contamination

The U.S. National Institutes of Health (NIH) said on Thursday it has suspended operations of its Pharmaceutical Development Section (PDS), a facility that makes products for certain clinical research studies, due to the discovery of fungal contamination in drugs it produced.

The problem first emerged in April, when two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination.

Vials made from the same batch were administered to six patients, although it is unknown whether those or other vials were contaminated. The NIH said in a statement that the patients have been notified and are being followed closely for any signs of infection.

At this time, none has developed signs of infection or illness, the U.S. government medical research agency noted.

Officials from the U.S. Food and Drug Administration (FDA), who inspected the PDS between May 19 and May 29, identified "a series of deficiencies" at the facility, including flaws in the air handling system, and operational failures such as inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures.

NIH Director Francis Collins called the situation "distressing and unacceptable". He said he will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible.

So far, it has notified the individual principal scientists responsible for each of those studies and is in the process of notifying the participants.

According to the NIH, about 250 patients in 46 clinical studies, who are currently scheduled to receive products manufactured by the PDS, are affected.

The vast majority of patients in these studies are not immediately due for treatment and the NIH said it is working to secure alternative sources for the products. Endi