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FDA Investigating how Surveillance Documents Posted Online

FDA Investigating how Surveillance Documents Posted Online

July 19, 2012 — The U.S. Food and Drug Administration (FDA) is currently investigating how a private document handling company inadvertently posted 75,000 pages of confidential files on a public website. The documents were part of a secret surveillance operation the FDA authorized against dozens of employees, five of whom were drafting whistleblower complaints about the FDA approving unsafe medical devices. On Sunday, the New York Times reported that they had reviewed the minute-by-minute surveillance.

The employees under surveillance have filed a lawsuit against the FDA, claiming that the surveillance was an illegal breach of privacy aimed at subverting whistleblowers. Although employers are allowed to monitor employees’ activities on work computers, they are not allowed to intimidate whistleblowers or impede complaints.

As part of the ongoing litigation, the Wall Street Journal reports that the FDA was required to answer document production requests. The documents were sent to an outside contractor, Quality Associates Inc. of Fulton, Maryland. The company was responsible for printing the electronic documents and distributing them to various parties in the litigation. Somehow, the confidential files became public on the Internet in May. The documents are no longer available online.

The surveillance program began in 2010, shortly after Dr. Jeffrey Shuren became director of the FDA’s medical device approval department. The Washington Post first disclosed the surveillance in January. The dispute began in 2008, when several employees of the FDA’s radiological medical device voiced concerns that the agency had approved dangerous devices against the recommendation of experts within the department. According to the employees, there were 12 devices in question, including several that could harm fetuses or cause breast cancer by delivering excessively high doses of radiation.

When they employees began using work computers to take their complaints to journalists, members of Congress, government officials, and lawyers, the FDA installed surveillance software on the computers. The software could take pictures of the monitor, log keystrokes, collect passwords, intercept emails, download documents on thumb drives, and send alerts when keywords were entered. For the next two years, as the employees drafted whistleblower complaints, the FDA collected at least 80,000 pages of documents.

The FDA has defended its actions by saying that they were only trying to ensure the employees were not disclosing trade secrets about the medical devices they were reviewing.

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