UPDATE 1-US group decries fewer FDA device inspections

Wed Feb 18, 2009 9:32pm GMT
 
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WASHINGTON, Feb 18 (Reuters) - The Project on Government Oversight (POGO) on Wednesday called for an investigation into the U.S. Food and Drug Administration's dwindling number of early laboratory inspections for high-risk medical devices.

The group urged lawmakers to give the FDA more funding to hire and train additional inspectors to monitor laboratories before manufacturers begin clinical trials.

FDA records show that early lab inspections dropped to 1 in 2008 from 33 in 2005, POGO said in a report released today.

The report said that in 2007, an FDA official said it was not feasible for companies to follow the FDA's lab regulations and that most do not.

POGO's Executive Director Danielle Brian said it was not clear whether the decline in inspections was because of budget issues or other pressures, possibly from companies.

"What we see this as is a case study of a bigger, more endemic problem with the FDA, where they are simply incapable of functioning the way they are intended to function," Brian told reporters.

A number of FDA scientists have complained that the agency's Center for Devices and Radiological Health (CDRH) stopped requiring device makers to undergo FDA preclinical lab inspections.

Under FDA regulations, companies must submit a safety study of their device and show compliance with the FDA's Good Laboratory Practices guidelines before getting approval to start clinical trials.   Continued...

 

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