Ironically, within hours of President Bush signing the FDA Amendments Act of 2007 into law, a report is released finding the U.S. Food and Drug Administration doesn’t do enough to ensure the safety of patients who help test drugs in clinical trials
The New York Times 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.
While FDA inspectors often show up long after the tests have been completed, the agency said it lacks the resources to do the job properly — it has 200 inspectors responsible for 350,000 testing sites.
Being Washington, the report also blames the regulators noting that FDA officials downgraded negative findings from inspectors 68 percent of the time. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.
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.
An inspector general’s report in 2000 criticized the oversight of clinical trials and noted that the inspections mostly focused on whether study information was accurate and not on whether human subjects were protected.
See the NY Times article here.
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