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Regulatory Focus™ > News Articles > Agency Takes Aim at FDA in Whistleblowing Guidance

Agency Takes Aim at FDA in Whistleblowing Guidance

Posted 21 June 2012 | By Alexander Gaffney, RAC 

A federal agency tasked with protecting whistleblowers has released a new guidance to other federal agencies urging them to "heed whistleblower rights when monitoring employee communications"-a warning seemingly directed squarely at the US Food and Drug Administration (FDA).

FDA has been under investigation by various agencies and legislators since January 2012 after six former employees of its Center for Devices and Radiological Health filed suit in federal court alleging the agency monitored their protected communications to members of Congress and other agencies in violation of the Whistleblower Protection Act.

One of those agencies, the Office of Special Counsel-an investigative and prosecutorial agencies largely tasked with protecting whistleblowers-opened an investigation into FDA in February in light of what it called "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."

"Monitoring employee emails with OSC or Congress could dissuade employees from making important disclosures," said Special Counsel Carolyn Lerner in a statement in February.

Now OSC is firing off additional warning shots in the form of guidance to all federal agencies, though its language speaks largely to situations similar to those FDA now finds itself in.

"The memorandum, distributed by the Office of Management and Budget, underscores the right of federal workers to disclose wrongdoing without fear of retaliation," explained OSC in a statement. "It encourages agencies to ensure that their monitoring policies and practices do not interfere with or discourage employees from disclosing wrongdoing, including whistleblowing to the Office of Special Counsel or an agency Inspector General."

The agency adds that any monitoring conducted by agencies must be legitimate in purpose and not "chill employees from disclosing wrongdoing."

"Agencies should create a climate that encourages employees to report problems," concludes Lerner.  "Whistleblowers are essential to good government, because they help root out waste, fraud and abuse, and save taxpayers billions of dollars."

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