Campaign Against FDA Whistleblowers Inquiry Heats Up

Jane Akre
July 17, 2012

July 16, 2012 ~Most Americans believe the U.S. Food and Drug Administration (FDA) does a fairly adequate job at least keeping us safe from dangerous pharmaceuticals, medical devices, and food. However, a story in the New York Times (here) outlines the length to which the FDA went after its own whistleblowers when they tried to go outside of the agency to report unsafe medical devices and the pressure to approve them.

Earlier this year a group of five current and former FDA employees filed a whistleblower lawsuit claiming they were illegally monitored by the agency with sophisticated software technology after reporting they were being forced to approve risky medical devices.

The Times writes that the campaign went outside of the five employees and involved 80,000 documents tracking communications with 21 in all including Congressional staffers who were suspected of receiving confidential information that could harm a corporation, academics and journalists.

Now a Maryland Democrat is urging Kathleen Sebelius who heads the health and human services to conduct a full-blown investigation into whether or not the federal employees protections and whistleblower laws were violated.

The Times reported Sunday (here) that as far back as January 2009, the employees complained to the incoming Obama administration that they were being investigated by the FDA’s Office of Criminal Investigation after a November 2008 letter first alerted FDA officials that they were being intimidated by superiors. The Office of Special Counsel, in a confidential memo, found a “significant likelihood” that the devices complained about did post a public safety danger.

What sort of devices? Breast and colon cancer imaging devices that put out unsafe levels of radiation for one.

So far two of the five have lost their jobs and one has been suspended.

Did the FDA break the law? While federal agencies can look into employees computer use, the net was cast widely to include attorney-client communication, complaints by the whistleblowers to Congress and workplace grievances filed with the proper authorities.

Stephen Kohn, executive director of the National Whistleblower Center says the health and safety violations were deplorable.

“The spying program… was illegal… Government managers used a covert spying program to interfere with the ability of federal employees to lawfully report significant threats to the public safety to Congress, law enforcement officials and the American people. We hope that these public disclosures will mark the beginning of the end of government spying on employees who report misconduct to the appropriate authorities.”

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