- The National Institutes of Health (NIH) has permanently closed a facility used to produce drugs for early-stage clinical trials as part of an ongoing review of all aseptic manufacturing at the NIH's Clinical Center.
- Last year an inspection by the Food and Drug Administration revealed serious violations of proper sterility procedures at the NIH's Pharmaceutical Development Section (PDS) and the Clinical Center's pharmacy. The NIH promptly suspended sterile production, but a recently posted letter from the FDA reveals the NIH permanently closed the PDS on May 27.
- A new interim pharmacy unit, reflecting modifications to resolve the violations flagged by the FDA, is slated to open by the end of October, according to the letter.
In May of last year, an unscheduled inspection by FDA staff uncovered a number of lapses in good manufacturing practices (GMP) at the Pharmaceutical Development Section, which the NIH used to produce drugs for Phase 1 and Phase 2 clinical trials.
A month prior, two vials of albumin, a drug used to administer interleukin in experimental studies, were found to be contaminated. Other vials from that same batch had been administered to six patients, although none developed infection or illness.
Since then, the NIH has moved to remedy the violations—suspending sterile production and hiring a contracting firms to evaluate PDS operations. NIH director Francis Collins quickly appointed a task force to examine the deficiencies, before eventually setting up a new Office of Research Support and Compliance in December 2015.
But the NIH decided in May to permanently close the PDS after completing the first phase of its review, thereby halting all aseptic manufacturing of sterile products at the unit.
"Phase 2 reviews begin this month and will look at instrumentation qualification, standard operating procedures and training, under the oversight of the newly established NIH Office of Research Support and Compliance," a spokesperson for the agency said in a statement.
The NIH plans to seek alternative sources to provide the products it typically would produce at the PDS, but there are no plans for any future restart of the unit.
Less severe violations had also been found last year in the Clinical Center's pharmacy unit, known as the Intravenous Admixture Unit, or IVAU. The NIH has since taken, in the words of the FDA, "significant steps" to resolve the problems and current plans for an interim IVAU represent a "substantial improvement" over past practices.
"By the end of this calendar year, we expect a new interim Intravenous Admixture Unit (IVAU) to be operational," an NIH spokesperson said.
A laboratory at the National Cancer Institute and a National Institute of Mental Health facility were also caught up in the NIH's review. As a result of the NIH's efforts to check compliance, violations were found in both facilities, leading to a suspension of work. The suspension affected 13 clinical studies tied to Kite Pharma and Lion Biotechnologies, but five have since restarted, according to EP Vantage.