Los Feds despejan el grupo del dispositivo del FDA de mala conducta

por Brendon Nafziger, DOTmed News Associate Editor | November 09, 2010
For the second time this year, federal inspectors have cleared the U.S. Food and Drug Administration of any wrongdoing over allegations that agency officials bullied reviewers who refused to approve medical devices they thought unsafe, according to the Associated Press.

"[T]his case is closed," concluded the Oct. 14 report by the Office of the Inspector General for the U.S. Department of Health and Human Services, according to the AP.

In its review of administrative misconduct, the OIG said there was no evidence managers punished employees, echoing findings of a February investigation into criminal violations, where the OIG said there was no evidence of wrongdoing.
DOTmed text ad

New Fully Configured 80-slice CT in 2 weeks with Software Upgrades for Life

For those who need to move fast and expand clinical capabilities -- and would love new equipment -- the uCT 550 Advance offers a new fully configured 80-slice CT in up to 2 weeks with routine maintenance and parts and Software Upgrades for Life™ included.

Both investigations stem from a 2008 complaint by nine anonymous whistleblowers at the agency who said officials pressured reviewers within the Centers for Devices and Radiological Health to approve devices despite safety concerns or lack of evidence for effectiveness.

But some of the whistleblowers remain unmollified. Dr. Julian Nicholas, a gastroenterologist and former CDRH reviewer who claimed this summer he was sacked from the agency for refusing to approve CT scanners for virtual colonoscopies, told the AP he wasn't contacted for the OIG's investigation.

"It's hard for me to believe this was a bona fide investigation when they haven't even contacted the people who reported these violations," he told the AP.