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FDA Gets New Authority Over Clinical Trial Reporting



9/26/2012 8:16:06 AM

Here is an interesting development in the ongoing controversy over reporting clinical trial data in all its glory to the federal government. The US Department of Health & Human Services has transferred authority to the FDA to oversee information that is filed with ClinicalTrials.gov – the clinical trial registry data bank – and seek out those who fail to file, or file misleading or false data, according to a statement in the Federal Register (see here). Of course, the FDA reports to the HHS, but the move is likely to be more than symbolic, given the scandals that have ensued in recent years over a failure to provide complete trial data. Examples include the Avandia diabetes pill sold by GlaxoSmithKline, which recently paid a $3 billion settlement, partly for failing to report safety data (read this). And evidence that Merck hid risks associated with its Vioxx painkiller continues to emerge (look here).

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