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Congressman Wants Name of FDA Official who Authorized Surveillance

Congressman Wants Name of FDA Official who Authorized Surveillance

July 17, 2012 — An ongoing Congressional investigation into the U.S. Food and Drug Administration (FDA) electronic surveillance of whistleblower employees has uncovered evidence that the program was explicitly authorized from the agency’s top leaders. One of the Congressmen whose emails were collected in the surveillance, Senator Charles E. Grassley (R-Iowa), said in a Washington Post article that “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.” Grassley and others are now demanding to know the name of the official who authorized the surveillance.

The saga began in 2007, when several FDA scientists, researchers, and doctors became concerned that the agency heads had approved 12 unsafe radiological devices against the recommendations of experts within the agency. In recent years, the FDA has faced mounting criticism for approving devices with serious safety issues — including metal-on-metal hip implants, brain stents, transvaginal mesh, and more.

In 2010, the FDA sent a request to the Department of Human Services (DHS) to pursue a criminal investigation against the scientists. The FDA alleged that they had evidence that the employees were disclosing trade secrets about the medical devices they were criticizing. DHS denied the agency’s request. According to documents obtained under the Freedom of Information Act, that same year, the FDA purchased surveillance software and placed it on the employees’ computers.

Over the next two years, the employees continued to voice their concerns about unsafe devices being approved by the FDA. They corresponded with Congressional officials, lawyers, and journalists. They drafted whistleblower complaints. All of this communication was done on a work computer, and all of it was under surveillance — a keystroke-logger collected passwords, sent alerts when certain keywords were entered, collected emails, took snapshots of the monitor, downloaded the contents of thumb drives, and more.

According to the New York Times investigation, the surveillance collected 80,000 pages of documents which were apparently accidentally posted on a public website. Documents included lists of targets for future surveillance and draft complaints being prepared by the scientists to disclose wrongdoing to the federal government.

Employers have strongly-protected rights to monitor employee activity on a work computer. However, it is illegal to use surveillance as a way to intimidate whistleblowers. Employers cannot deter employees from voicing concerns about safety, corruption, or other abuses. Any employer action that might have a “chilling effect” on other whistleblowers is also illegal.

Although the FDA claims it was just trying to make sure the employees were not leaking trade secrets, many people are now questioning the agency’s motives in surveilling employees who were voicing serious public health concerns. All six of the employees were fired, disciplined, or passed over for promotions.

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