FDA slammed on clinical trials oversight

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The FDA is failing to adequately police clinical trials, according to a report by the inspector general of the Department of Health and Human Services.

HHS IG Dan Levinson said the agency's oversight of clinical trials was disorganized, overly reliant on voluntary compliance and wholly inadequate, with inspections to an estimated 1% of clinical trial sites from 2000-2005. Guidance and regulations, he wrote, do not reflect current clinical trials practices.

HHS OIG recommended: that the agency develop a clinical trial database including all clinical trials, a step mandated under the omnibus FDA overhaul bill signed into law yesterday; the creation of an institutional review board registry, allowing for better inspection of review boards; creation of a cross-center database to facilitate better tracking of inspections; the establishment of a mechanism that ensures better feedback between investigators and agency centers; and new powers allowing inspectors to delve deeper into a clinical trial.

Rep. Rosa DeLauro (D-CT) told The New York Times that the FDA was “passive, they're reactive, and they often side with industry over public health.”
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