The National Institutes of Health has halted production at a plant that makes drugs for clinical trials after discovering some alarming manufacturing mishaps, a move that affects 46 ongoing studies.
In an inspection last month, the FDA noted some serious contamination issues at the NIH's Bethesda, MD, manufacturing facility, called the Pharmaceutical Development Section, or PDS. Investigators found two vials of albumin that contained fungus, the FDA said, and vials from that same batch were administered to 6 patients.
NIH doesn't know whether those vials were contaminated, but the agency has suspended all production at PDS until it can rectify a host of compliance issues. The 6 patients have thus far shown no signs of infection, NIH said, but physicians are following them closely to be sure.
In the 46 studies affected by PDS's sudden hiatus, about 250 patients are scheduled to receive drugs manufactured at the facility, NIH said. The vast majority of those patients aren't in immediate need, the agency said, and NIH is working to lock down alternative sources for the drugs in question.
The problems at PDS stem from facility issues, including air filtration and pressure, and process problems like inadequate sterilization and insufficient employee training, according to the FDA.
"This is a distressing and unacceptable situation," NIH Director Francis Collins said in a statement. "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."
Those steps include bringing in an external group of experts to audit how PDS produces drugs, reviewing its policies, staffing and training before making recommendations to Collins.
- read the statement
- here's the FDA citation (PDF)