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FDA investigates how confidential files went public

An FDA worker checks samples for salmonella.

An FDA worker checks samples for salmonella. // Food and Drug Administration

The Food and Drug Administration is investigating how a document-management company apparently inadvertently made public 75,000 pages of confidential files about how medical devices were approved at the agency, the Wall Street Journal reports.

The documents are largely related to a surveillance operation that involved monitoring the email inboxes of five agency scientists who complained in 2008 about the way new medical devices were being greenlit by the FDA's medical-device center.

The agency used spy software that logged their keystrokes, intercepted their personal emails, copied the documents on their personal thumb drives and tracked their messages as they were drafted in real time, according to a New York Times investigative report. The scientists filed lawsuits against the FDA.

During the process of answering document requests in that litigation, the FDA made the files available to an outside contractor, Quality Associates Inc. of Fulton, Md., officials told the Wall Street Journal. The company was hired to print the materials and make them available to various parties in the litigation. The agency officials said the confidential files were available to the public on the Internet for at least several days as recently as May of this year.

The news comes as Transportation Security Administration is shopping for a computer program to snoop into the online activities of agency employees for signs of potential leaks, NextGov previously reported.

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