U.S. Report Faults FDA Oversight of Drug Trials
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.
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