Congressman Wants Name of FDA Official who Authorized Surveillance

July 17, 2012 — Congressman Charles E. Grassley (R-Iowa) is calling for release of a memo with the name of the U.S. Food and Drug Administration (FDA) official who authorized surveillance of five whistleblower employees. The surveillance also collected correspondence from Congressman Grassley, other government officials, journalists, and lawyers, as the employees expressed concerns and drafted whistleblower complaints. In a Washington Post article, Grassley said “The FDA’s actions represent serious impediments to the right of agency employees to make protected disclosures about waste, fraud, abuse, mismanagement, or public safety.”

The FDA has been criticized for approving several medical devices with serious safety issues, such as transvaginal mesh, metal-on-metal hip implants, brain stents, and more. Many of these devices were fast-tracked through the approval process without being required to conduct safety studies.

The employees began voicing their concerns about 12 radiological devices back in 2007, including devices that could cause cancer or kill fetuses by delivering excessively high amounts of radiation. In 2010, FDA officials asked the Department of Human Services (DHS) for permission to pursue a criminal investigation against the employees, allegedly because they were leaking trade secrets. DHS did not allow a criminal investigation. In that same year, documents obtained under the Freedom of Information Act reveal that the FDA purchased surveillance software.

For the next two years, the surveillance software collected approximately 80,000 pages of documents from the employees. The software took pictures of the monitor, collected passwords, intercepted email correspondence, downloaded documents on thumb drives, and sent alerts when certain keywords were entered.

Then, according to the New York Times the documents were accidentally posted on a public website. The Times journalists reviewed correspondence, drafts of whistleblower complaints, and more.

FDA officials continue to assert that they did nothing wrong, and they initiated the surveillance program to make sure the employees were not leaking trade secrets about medical devices. Furthermore, when the work computers were turned on, they displayed a warning that employees had no expectation of privacy while using the computers.

Although employers are allowed to monitor the activities of employees using a work computer, they are not allowed to intimidate whistleblowers, because this might deter employees from alerting the government about corruption, safety issues, or other abuses. It is illegal for employers to engage in any activity that might have a “chilling effect” on whistleblower lawsuits.

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