WASHINGTON (AP) -- A new report says the Food and Drug Administration gives little oversight to the testing of experimental drugs and medical devices on millions of patients.
Health and Human Services Department inspector general Daniel Levinson raises questions about the FDA's ability to ensure the safety of study participants. His report says the agency inspected just one of every 100 clinical trial sites over a six-year period.
The report indicates that even when inspectors do turn up serious problems, senior officials frequently downgrade the findings. It says the problems are rarely followed by inspections to see whether the issues have been resolved.
The FDA says inspections make up only one part of its efforts to ensure participants are protected. The most important step to ensure safety, the agency says, is its review of study protocols before the trials get under way.
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