FDA clinical trial oversight blasted

WASHINGTON, Sept. 28 (UPI) -- A new report says the Food and Drug Administration is failing to properly keep an eye on the thousands of U.S. clinical trials.

A review by Department of Health and Human Services Office of Inspector General Daniel R. Levinson found that federal health officials didn't even know how many clinical trials were being conducted, The New York Times said Friday.

The report said the FDA has 200 inspectors to police an estimated 350,000 testing sites. It estimated that only 1 percent of all clinical trials were audited between 2000 and 2005. The FDA also was faulted for failing to make sure that any problems found are properly addressed.

The FDA oversees the safety of trials by companies seeking approval to sell drugs or devices. There is no federal oversight for private, noncommercial trials, the newspaper said.

The inspector general's report calls for the creation of a comprehensive database of all clinical trials, a federal registry of clinical trial inspectors and increased legal oversight.

Copyright 2007 by United Press International

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