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FDA spying may have broken whistleblower laws, congressional probe finds

Two years after press reports revealed that the FDA was extensively monitoring communications by some of its employees, a congressional committee has wrapped up its investigation. The verdict, announced by Rep. Daryl Issa (R-CA) and Sen. Charles Grassley (R-IA): The agency overstepped its authority–and may have broken laws meant to protect whistleblowers.

According to a joint report of the House Oversight and Government Reform Committee and the Senate Judiciary Committee, the FDA launched a surveillance program to monitor employees who contacted legislators with concerns about the agency’s medical device approval process. The FDA used a software program called Spector 360 to spy on 5 employees, the report says.

FDA managers were allegedly free to review correspondence between the employees and Congress, the U.S. Office of Special Counsel (OSC), and any attorneys who may have been involved, according to a statement released by the House Oversight and Government Reform Committee. The investigators “found the FDA acted without regard for employees’ whistleblower rights, which protect their communications to Congress and OSC.”

The FDA also conducted the program without setting up adequate guidelines, the committee found. Nor did the agency make an effort to exclude “protected communications” from surveillance, according to the report.

The saga of the FDA surveillance program dates back to 2007, when several employees reportedly complained internally that at least 12 radiological devices had been approved, despite adequate proof that they worked. Some of the devices used radiation levels that could cause cancer in healthy people, they alleged. In 2012, 6 former FDA employees sued the agency claiming they were fired, harassed, or passed over for promotions because they reported their concerns about device approvals. That lawsuit is still pending.

An FDA spokeswoman told Reuters that the agency is reviewing Congress’ full report but that “many of the findings outlined paint an incomplete picture of the matter.” She added that the agency did not target any employees or retaliate against them for their complaints to Congress.

– read the Reuters story
– here’s the statement from Congress
– access Issa and Grassley’s complete report here

February 27, 2014 | By 

Read more: FDA spying may have broken whistleblower laws, congressional probe finds – FiercePharma http://www.fiercepharma.com/story/fda-spying-may-have-broken-whistleblower-laws-congressional-probe-finds/2014-02-27#ixzz2uZdS75mz
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