‘Quality And Safety’ Issues Halt Work At NIH Labs For Internal Inquiry
Lab conditions and the risk of contamination were determined to not be suitable to produce clinical-study drugs at two facilities. No evidence of patient harm has been found.
The Wall Street Journal:
Inquiry Halts Work At Two NIH Labs
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. (Burton, 4/19)
NPR:
NIH Halts Some Research Amid Concerns Over Contamination And Safety
"There is no evidence that any patients have been harmed, but a rigorous clinical review will be undertaken," the NIH said in a statement provided to NPR Tuesday. "NIH will not enroll new patients in affected trials until the issues are resolved." (Greenfieldboyce, 4/19)
STAT:
Contamination Problems Prompt NIH To Suspend Operations At Two Facilities
The National Institutes of Health has suspended operations at two of its facilities involved in clinical research trials after a probe last year identified serious contamination problems. (Scott, 4/19)
