recommended reading

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.

Threatwatch Alert

Thousands of cyber attacks occur each day

See the latest threats


Close [ x ] More from Nextgov

Thank you for subscribing to newsletters from
We think these reports might interest you:

  • It’s Time for the Federal Government to Embrace Wireless and Mobility

    The United States has turned a corner on the adoption of mobile phones, tablets and other smart devices, outpacing traditional desktop and laptop sales by a wide margin. This issue brief discusses the state of wireless and mobility in federal government and outlines why now is the time to embrace these technologies in government.

  • Featured Content from RSA Conference: Dissed by NIST

    Learn more about the latest draft of the U.S. National Institute of Standards and Technology guidance document on authentication and lifecycle management.

  • A New Security Architecture for Federal Networks

    Federal government networks are under constant attack, and the number of those attacks is increasing. This issue brief discusses today's threats and a new model for the future.

  • Going Agile:Revolutionizing Federal Digital Services Delivery

    Here’s one indication that times have changed: Harriet Tubman is going to be the next face of the twenty dollar bill. Another sign of change? The way in which the federal government arrived at that decision.

  • Software-Defined Networking

    So many demands are being placed on federal information technology networks, which must handle vast amounts of data, accommodate voice and video, and cope with a multitude of highly connected devices while keeping government information secure from cyber threats. This issue brief discusses the state of SDN in the federal government and the path forward.

  • The New IP: Moving Government Agencies Toward the Network of The Future

    Federal IT managers are looking to modernize legacy network infrastructures that are taxed by growing demands from mobile devices, video, vast amounts of data, and more. This issue brief discusses the federal government network landscape, as well as market, financial force drivers for network modernization.


When you download a report, your information may be shared with the underwriters of that document.