The National Institutes of Health shut down production of clinical-study drugs at two laboratories after an internal inquiry found them “not in compliance with quality and safety standards.”
One lab of the National Cancer Institute, and another of the National Institute of Mental Health, weren’t suitable to produce the sterile or infused drugs that have been used in clinical studies, the inquiry found. However, NIH officials said they are working rapidly and hope to have the laboratories up and running again soon.
The cancer study involves 13 terminal patients with metastatic disease, in which each person’s immunotherapy is individualized for that patient. NIH officials weren’t immediately able to give details about the mental health study, in which the lab makes a contrast agent used in certain brain imaging.
The NIH said it has no evidence that patients were harmed as a result of the production issues, but that it still is conducting a clinical evaluation. The agency’s actions stem from findings by two quality-assurance and drug-compounding companies brought in to evaluate NIH study-drug production.
“We’re going to work with the facilities to get them in compliance,” said Kathy Hudson, an NIH deputy director who helps oversee the drug-study issue at the agency. “The entirety of NIH is working shoulder-to-shoulder to make this happen as soon as we can.”
The inquiry originated from sterility problems uncovered in the NIH Clinical Center pharmacy nearly a year ago. Dr. Hudson said that issue served as a “canary in the coal mine” that caused the NIH to look at clinical-study drug production more broadly.
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