FDA Investigating how Surveillance Documents Posted Online

July 19, 2012 — Officials at the U.S. Food and Drug Administration (FDA) are trying to find out how 75,000 pages of confidential documents were accidentally posted on a public website. The documents were collected during a secret surveillance program enacted against dozens of FDA employees, including five who were drafting whistleblower complaints. The employees were doctors and scientists who were concerned that FDA officials were ignoring safety issues when they approved radiological devices. The New York Times reported the leak on Sunday, and also said that had reviewed documents that included minute-by-minute surveillance of the employees.


Soon after the Washington Post disclosed the surveillance operation in January, five employees who were placed under surveillance filed a lawsuit against the FDA, alleging that the agency illegally violated their privacy as a way to subvert whistleblowers. Employers have broad rights to monitor employees while they are using work computers, but it is illegal for an employer to intimidate or oppress whistleblowers.

As part of the discovery process in the lawsuit, the FDA was required to turn over the relevant documents that were collected on the employees. Approximately 80,000 pages of documents were given to a private, third-party document-handling agency, Quality Associates Inc. based in Fulton, Maryland. The company was hired to collect the documents, print them, and sent them to the parties involved in the lawsuit. Somehow, during this process, the documents were posted on a public website for at least a few days in May. The documents have been taken off the website.

The FDA began monitoring the employees in 2010, soon after Dr. Jeffrey Shuren became the director of the agency’s medical device office. Several doctors and scientists within the department had been complaining for years that the agency was ignoring safety issues and approving unsafe radiological devices, some of which could cause cancer or harm fetuses. Soon after the Department of Human Services (DHS) denied the FDA’s request to pursue a criminal investigation against the employees, officials at the FDA authorized an electronic surveillance program to monitor the employees’ activities on work computers.

For the next two years, the employees used their work computers to contact members of Congress, draft whistleblower complaints, complain to government officials, and contact lawyers. All of these communications were intercepted and collected as evidence, and then accidentally posted online. The surveillance software collected the employees’ correspondence with members of Congress, and much more.

FDA officials have responded by stating that they were only trying to protect trade secrets and ensure the whistleblower employees were not disclosing confidential information about the devices they were criticizing.

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