HHS OIG Report Cites Problems With FDA Oversight Of Clinical Trials

October 1, 2007 – 1:10 pm | posted in Clinical Trials / Drug Trials

FDA does not take adequate action to ensure the safety of millions of participants in clinical trials, according to a report from the HHS Office of Inspector General scheduled for release on Friday, the New York Times reports.

According to the report, written by HHS Inspector General Daniel Levinson, FDA — which oversees trials conducted by companies that seek approval to market medications and medical devices — lacks information on the number of ongoing trials, audits less than 1% of trial sites and often performs inspections of the sites after the completion of trials. FDA has 200 inspectors, some of whom audit trials part time, to inspect about 350,000 sites, the report found. In addition, the report found that FDA officials downgrade serious violations found by inspectors at trial sites 68% of the time and that the agency in many cases does not perform additional inspections to determine whether recommended corrective actions occurred.

The report recommended that FDA establish a registry of all ongoing trials, a complete registry of research ethics boards and a database of inspections of trial sites, as well as obtain more authority to regulate research assistants.

According to some research ethics experts, the problems with FDA oversight of trials cited in the report are, “in many ways, identical to criticisms leveled at other agency functions, including its oversight of imported food, foreign drug manufacturers, animal food and the safety of older medicines,” as the “size and complexity of the tasks facing the agency have grown enormously as the number of inspectors for those tasks has generally declined,” the Times reports (Harris, New York Times, 9/28).

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