NIH closes drug production facility blamed for contamination issues

The National Institutes of Health (NIH) has permanently closed its facility that manufactured investigational drugs a year after “a series of deficiencies” were found in the unit by Food and Drug Administration (FDA) inspectors.

The issues in the Pharmaceutical Development Section, or PDS, located within the NIH Clinical Center in Bethesda, Maryland, were first discovered in April 2015. Fungal contamination was discovered in vials of albumin in the PDS after vials from the same batch were administered to six patients. These safety issues led to the FDA inspection and subsequent closure of the section’s sterile production unit.

In a July 29 letter to NIH, the FDA’s compliance director, Thomas Cosgrove, said “ongoing work in the PDS had been decommissioned” as of May 27.

The clinical center’s other drug production facility, the Intravenous Admixture Unit (IVAU), is focused on drug compounding, but had been cited for similar safety violations, like not adequately separating hazardous and non-hazardous operations. The current facility remains in use, but the FDA letter stated NIH plans to move into an interim space by October 31, while a new IAVU is built “that will meet or exceed all relevant regulatory requirements.”

The safety issues identified by the FDA last week led to a series of changes at the center. An agency-appointed task force released a report in April 2016 which said the center had emphasized research needs over patient safety, which led to agency director Francis Collins appointing a new management team at the facility.

The gaps in sterility processes weren’t limited to drug production, either. Two labs, one which produces PET materials, and another involved in cell production therapy, were closed in April 2016 after the agency found evidence the labs were “not in compliance with quality and safety standards.”