FDA managers cleared in device division probe

Federal investigators have determined FDA managers didn't lash out against staffers who disagreed with the approval of several devices, said the inspector general for HHS. The investigation resulted from a letter sent by scientists and physicians to the White House in January 2009. The whistleblowers claimed that the agency's process for reviewing potential new medical devices had been "corrupted and distorted by current FDA managers, thereby placing the American people at risk," according to the Wall Street Journal. Specifically, the group said outside stakeholders were influencing the review process and managers had taken punitive action against those who'd objected to the approval of certain devices.

FDA chief counsel Ralph Tyler said the FDA revealed the inspector general's findings because two members of the group voiced their objections at this weeks' FDA meeting on the overuse of CT scans that was closely watched by the media and medical community. 

Although no criminal charges will be filed, the whistleblowers have been asked to meet with management advisors hired to help resolve issues that were not addressed by the investigation and to restore confidence in the device division. "At least management has recognized that some of the violations of regulations we raised may not be criminal, but are nonetheless serious, and hurt the workings of the division," one whistleblower told the WSJ.

- here's the Wall Street Journal article

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