Report faults FDA oversight of drug trials

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http://news./s/nm/20070928/hl_nm/fda_safety_dc

Report faults FDA oversight of drug trials

 

Fri Sep 28, 11:30 AM ET

 

WASHINGTON (Reuters) - A report to be released on Friday finds the U.S. Food and Drug Administration does very little to ensure the safety of patients who help test drugs in clinical trials, The New York Times reports.

 

It quotes Daniel Levinson, the inspector general of the Department of Health and Human Services, as saying FDA officials do not know how many clinical trials are being conducted and have audited fewer than 1 percent of the testing sites.

FDA inspectors often show up long after the tests have been completed, the Times quotes the report as saying.

HHS is the parent department of the FDA, which, among other duties, approves new drugs. Clinical trials -- those involving real human patients -- are a key part of this approval process.

But the FDA has been accused of lax oversight of drug trials in general. The agency has said it lacks the resources to do the job properly.

It has 200 inspectors who are responsible for 350,000 testing sites, the Times said.

The report found that top drug officials in Washington downgraded negative findings from these inspectors 68 percent of the time.

The FDA disqualified researchers from conducting further clinical trials 26 times from 2000 to 2005 and disqualified their data twice, although it found serious problems at trial sites 348 times, the newspaper quotes the report as saying.

Levinson recommended that the agency create a registry of all continuing clinical trials.

President George W. Bush signed a measure into law on Thursday that will give the FDA more power and money to do this as part of better policing of reports of dangerous side effects from prescription drugs after they reach the market.

The legislation is largely a response to a string of drug safety controversies, including the 2004 withdrawal of Merck & Co Inc's widely used arthritis pill Vioxx after it was linked to heart attacks and strokes.