OIG accuses FDA of severe lack of oversight
WASHINGTON According to a report by the Department of Health and Human Services Office of the Inspector General, the Food and Drug Administration does not know how many clinical trials are going on at any given time.
The report also said that the FDA is unaware of how many sites are conducting these trials and how many institutional review boards are overseeing them. The FDA’s over reliance on voluntary compliance by the recipients of warning letters and other weaknesses in information systems and management processes harm its oversight of clinical trials.
“Warning letters and untitled letters rely on voluntary compliance, so [the] FDA must re-inspect individuals who receive these letters to ensure that they do not repeat violations in future clinical research,” the OIG report says.