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University’s PET research halted after repeated violations of FDA regulations

The New York Times reported this week that a university has quietly stopped research at a well-known brain imaging center after federal investigators found that it had regularly injected mental patients with drugs that contained potentially dangerous impurities. The brain imaging center is regarded by experts as the nation’s leader in the use of positron emission tomography (“PET”) for psychiatric research. However, the federal investigations revealed that the brain imaging center repeatedly violated Food and Drug Administration (“FDA”) drug safety regulations over a four-year period.

PET research is a nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body. In the university’s brain imaging center, the FDA found in a series of inspections that the center had failed to correct manufacturing problems in a lab that makes experimental drugs injected into psychiatric patients to help capture images of brain activity. In one product liability warning letter, an FDA office described problems dating back to at least 2004 citing a litany of violations, including a failure to reject batches of medication that did not pass required tests.

More information on the FDA violations is available at the New York Times website.