Published On: Fri, Jun 5th, 2015

Contamination Forces NIH to Suspends Drug Production for 46 Clinical Trials

fda-suspends-drug-productionWall Street Journal — The National Institutes of Health suspended production of clinical-study drugs for 46 different clinical trials, after two vials of drugs were found to have fungal contamination and federal inspectors found deficiencies in the way drugs are made there.

Two vials of albumin derived from human blood were found to be contaminated with fungus. Vials from the same batch had been given to six patients, but none has developed signs of infection or illness, the NIH said.

NIH Director Francis S. Collins called the developments a “distressing and unacceptable situation,” adding that “the fact that patients may have been put in harm’s way…is deeply troubling.”

Among the most serious consequences of suspending production is the fact that about 250 patients were due to receive the drugs imminently. Some will get alternative drugs, including some commercially available. Patients for whom an alternative isn’t available will continue to receive medicines made at the NIH, said Lawrence A. Tabak, the NIH principal deputy director.

Thomas M. Burton

Thomas M. Burton

Wall Street Journal reporter writing about medicine and the FDA. Winner of the Pulitzer Prize for Explanatory Journalism.
Thomas M. Burton

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