Serious manufacturing issues tied to fungal contamination in NIH facility

NIH headquarters--Courtesy of NIH

The FDA, which has been going full bore after offending compounding pharmacies, has now turned its attention to one of its sister agencies. The result is that the National Institutes of Health has closed its Pharmaceutical Development Section after FDA inspectors found "serious manufacturing problems" that resulted in fungal contamination in a drug used in clinical trials.

The NIH said FDA inspectors checked out the operation in May after tests earlier determined that two vials from a batch of albumin used for the administration of the drug interleukin in experimental studies, had fungal contamination. The agency said 6 patients had already been injected from vials from the same batch, although it didn't know if those vials were also tainted. The agency said none of the 6 have shown signs of infection.

According to the inspection report, which the NIH posted, the FDA uncovered problems with the section's air handling systems, saying the aseptic area was not adequately separated from the common pharmacy and that an employee that was processing sterile drugs had an exposed arm which could result in contamination.

"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 a panel of outside experts to evaluate its procedures. It also has had to notify 250 patients in 46 drug studies who were slated to get drugs made by the NIH that it has closed down drug manufacturing but is looking for alternatives for them. Both the NIH and FDA operate under the Department of Health and Human Services.

It was fungal contamination of steroids manufactured by New England Compounding Center (NECC) that led to a nationwide fungal meningitis outbreak in 2012 that infected 750 people, of whom 64 would die. Federal authorities last year indicted former owners and employees of the now defunct compounding pharmacy, including two who were indicted on 25 counts of second-degree manslaughter. It also led to a crackdown by the FDA on the largest drug compounders and eventually to a new law that gave the agency more authority over the industry.

- here's the NIH announcement
- read the inspection report