OSC Now Involved Over Probe on FDA Employee Whistleblowers

OSC Now Involved Over Probe on FDA Employee Whistleblowers

February 16th, 2012 // 2:35 pm @

Source: Pharmalot

The probe into the sensational charges that the FDA secretly monitored several former and current employees, and then harassed and dismissed some of them, has now widened. The Office of Special Counsel, which is an independent federal investigative and prosecutorial agency, is also investigating. This follows a probe opened by the House Committee on Government Oversight and Reform (see here).

The back story: the employees accused the FDA of secretly reading their personal email accounts, while the agency maintained they illegally disclosed confidential business information after writing to Congress to complain they were being coerced to approve devices that posed unacceptable risks (back story). The recently filed a lawsuit charging the FDA repeatedly attempted to initiate formal criminal investigations and harmed their reputations.

They were motivated by alleged problems. The employees, who are all scientists and doctors, charged three devices could have missed signs of detecting breast cancer, according to the paper. Other examples: one device risked falsely diagnosing osteoporosis and an ultrasound device could malfunction while monitoring pregnant women in labor.

In a statement, the OSC notes the FDA acknowledged monitored emails that were sent by employees at the Center for Devices and Radiological Health to congressional investigators and also OSC staff. And the OSC says it has received “new and troubling allegations of retaliatory surveillance of OSC communications and other acts of retaliation against the whistleblowers, including FDA attempts to initiate criminal prosecution of the whistleblowers. We are reviewing these additional allegations and information from Congress and will take appropriate action.”

“Monitoring employee emails with OSC or Congress could dissuade employees from making important disclosures,” Special Counsel Carolyn Lerner says in a statement. “Monitoring communications with OSC is unacceptable. We encourage other agencies to review their policies to ensure that they are not monitoring or otherwise impeding employee disclosures to OSC or Congress.”

In a letter to FDA commish Margaret Hamburg last week, House committee chair Darrell Issa noted that federal law prohibits managers from initiating personnel actions against employees in response to protected whisteblowing.


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