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

JOIN THE DISCUSSION

Close [ x ] More from Nextgov
 
 

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

  • Modernizing IT for Mission Success

    Surveying Federal and Defense Leaders on Priorities and Challenges at the Tactical Edge

    Download
  • Communicating Innovation in Federal Government

    Federal Government spending on ‘obsolete technology’ continues to increase. Supporting the twin pillars of improved digital service delivery for citizens on the one hand, and the increasingly optimized and flexible working practices for federal employees on the other, are neither easy nor inexpensive tasks. This whitepaper explores how federal agencies can leverage the value of existing agency technology assets while offering IT leaders the ability to implement the kind of employee productivity, citizen service improvements and security demanded by federal oversight.

    Download
  • Effective Ransomware Response

    This whitepaper provides an overview and understanding of ransomware and how to successfully combat it.

    Download
  • Forecasting Cloud's Future

    Conversations with Federal, State, and Local Technology Leaders on Cloud-Driven Digital Transformation

    Download
  • IT Transformation Trends: Flash Storage as a Strategic IT Asset

    MIT Technology Review: Flash Storage As a Strategic IT Asset For the first time in decades, IT leaders now consider all-flash storage as a strategic IT asset. IT has become a new operating model that enables self-service with high performance, density and resiliency. It also offers the self-service agility of the public cloud combined with the security, performance, and cost-effectiveness of a private cloud. Download this MIT Technology Review paper to learn more about how all-flash storage is transforming the data center.

    Download

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