Research halted at NIH PET equipment facility over contamination concerns

Work has been put on hold at two National Institutes of Health (NIH) facilities after evidence was found that the laboratories are “not in compliance with quality and safety standards.”

The facilities include a National Institutes of Mental Health facility that produces PET materials, along with a National Cancer Institute lab involved in cell production therapy.

“There is no evidence that any patients have been harmed, but a rigorous clinical review will be undertaken,“ NIH said in a statement released Tuesday. “NIH will not enroll new patients in affected trials until the issues are resolved.”

These findings are the result of a review of all NIH production facilities after a separate safety issue in April 2015. Fungal contamination was discovered in vials of albumin at NIH’s Clinical Center Pharmaceutical Development Section, after vials from the same batch were administered to six patients. An inspection by the FDA in May 2015 found “a series of deficiencies” leading to the closure of the section’s sterile production unit.

Two companies – Working Building and Clinical IQ – were then hired by NIH to “evaluate all of its facilities producing sterile or infused products for administration to research participants.”

Along with the facility review, NIH Director Francis Collins, MD, PhD, formed a working group in December to “examine the structural and cultural issues and make recommendations to improve the organization, financing, and management of the NIH Clinical Center.” The group’s report is scheduled to be delivered to the Advisory Committee of the Director Thursday afternoon.