FDA Kept An Enemies List to Silence Critics

FDA Kept An Enemies List to Silence Critics

July 17th, 2012 // 12:24 pm @


Earlier this year, a group of current and former FDA employees filed a whistleblower lawsuit in which they claimed that personal e-mails were monitored after they warned Congress the agency was forcing employees to approve medical devices they maintained posed unacceptable risks. Now, though, documents relating to this case indicate the FDA was actually engaged in a broader campaign to counter outside critics of its review procedures, The New York Times writes.

The agency effort involving captured thousands of e-mails that the former and current FDA employees had sent privately to members of Congress and their staffers; lawyers; labor officials; journalists and President Obama, according to the paper (read an example here). The operation was uncovered by accident, though, when one of the disgruntled scientists found an Internet link to some 80,000 documents that was mistakenly posted by an FDA contractor.

In its defense, the FDA tells the paper that surveillance was limited to the five scientists suspected of leaking confidential info about safety and design of medical devices. The agency acknowledged the surveillance tracked communications with Congressional staffers and others, but insisted it was only intended to determine whether info was being improperly shared. FDA officials also insisted that people outside the agency were never targets, but were suspected of receiving confidential information.

As reported previously, the agency monitoring cited in the whistleblower lawsuit took place over a two-year period during which the FDA employees accessed their personal e-mail accounts from government computers. They claim they were harassed and eventually dismissed from their jobs in the Center for Devices and Radiological Health, but alleged various problems prompted their complaints, including devices that could have missed signs of detecting breast cancer (back story with documents).

The employees charge that the snooping began in January 2009, when they sent this letter to the Obama administration to complain that they were under investigation by the FDA Office of Criminal Investigation over a November 2008 letter sent by the chairman of the House Energy and Commerce Committee to FDA officials about allegations that the process for approving devices was coercive and intimidating.

The House Committee on Government Oversight and Reform subsequently began an investigation (read here). And the Times adds that a confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found the medical claims by the scientists were sufficiently valid to warrant a full investigation into what it termed “a substantial and specific danger to public safety.”

The Times writes cites one example in which intercepted e-mails revealed a few of the FDA employees who were under surveillance were drafting a complaint two years ago that they planned to send to the Office of Special Counsel. But shortly aftewards, but before the complaint was filed, two of the disgruntled employees were dismissed and a third was suspended.

The episode raises questions about whether the FDA broke the law. As the Times notes, federal agencies have discretion to monitor employee computer use, but the spying may have been illegal since confidential information the agency obtained is legally protected, including attorney-client communications, whistleblower complaints to Congress and workplace grievances filed with the government.

“The conduct by FDA managers, designed to undermine a group of doctors and scientists who reported significant health and safety violations, is deplorable. Those involved must be held accountable,” says Stephen Kohn, executive director of the National Whistleblower Center and the lead attorney for the FDA whistleblowers, in a statement. “…We hope that the revelations… will mark a turning point in the battle to stop the retaliatory surveillance of whistleblowers who risk their careers to report misconduct.

“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.

In fact, the White House Office of Management and Budget sent a governmentwide memo last month to emphasize that monitoring employee communications is permissble, the Times adds, but could not be used under the law to intimidate whistleblowers. Any monitoring must be done in ways that “do not interfere with or chill employees’ use of appropriate channels to disclose wrongdoing,” the memo reportedly said.

For those wondering how the FDA grabbed the info, the agency used spy software designed to help employers monitor workers, captured screen images from their government laptops as they were being used at work or at home, The Times writes, adding that “the software tracked keystrokes, intercepted personal e-mails, copied documents on personal thumb drives and followed line-by-line messages as they were drafted.” The software costs $2,875 to place on 25 computers.

One Congressional staffer tells us he is not surprised. “You could very easily capture any of the emails to Grassley staff simply by searching for @finance-rep.senate.gov. That’s why I always tell people to use their private accounts and use them from home on your personal computer. This surveillance program is outrageous and beyond the pale,” Paul Thacker, a former investigator for US Senator Chuck Grassley who worked with FDA whistleblowers during the time the agency surveillance program was in place.

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