FDA Executives Knew About Plan to Spy on Scientists

FDA Executives Knew About Plan to Spy on Scientists

August 9th, 2012 // 2:17 pm @

Top U.S. Food and Drug Administration executives knew about the monitoring of scientists’ emails after they questioned FDA safety standards, The Wall Street Journal reported. And although they didn’t order the surveillance, the agency leaders did tacitly condone the secret actions taken against employees who sought to keep the public safe from defective medical devices.

The electronic surveillance began in spring 2010 after pharmaceutical companies complained to the FDA that proprietary information about medical devices was leaked to the media, according to The Wall Street Journal, which cited FDA officials and a letter the agency sent to Senate investigators. The subjects of the monitoring were nine researchers who previously had alerted President-elect Barack Obama about lax safety protocols at the agency.
Whistle-Blowers Targeted by the FDA

Since the surveillance first was revealed several months ago, Sen. Chuck Grassley, R-Iowa, has pursued an investigation into how and why the whistle-blowers were targeted by the FDA. In addition to being a member of the judiciary committee that helps regulate civil liberties, Grassley has a personal interest because the agency intercepted protected correspondence to and from his congressional office. However, the senator is not alone in his concern that such underhanded actions by the agency could negatively affect the decisions of researchers who must deliver news of further safety issues.

Sources told The Wall Street Journal that the email monitoring began with one vocal scientist, Robert C. Smith, who was a medical officer in the radiological-devices branch. Information that was gathered from his computer led to an expansion of the operation to four additional whistle-blowers and then four more FDA staffers.
Suing the FDA

The employees are suing the FDA because they say the monitored emails were not just their work accounts, but also their personal email accounts, and because they have suffered retaliation because of their roles as whistle-blowers.

“The information secretly obtained by defendants included plaintiffs’ legally protected documents and information that was stored by plaintiffs in folders labeled ‘For Congress’ and other folders that clearly indicated the intent of plaintiffs to raise issues of public concern with appropriate authorities,” according to the Jan. 25 court filing, Bloomberg Businessweek reported.

The plaintiffs’ lead attorney and executive director of the National Whistleblowers Center, Stephen Kohn, said the group wrote about 20 medical devices, some used to screen for cancer, that were unsafe or ineffective. The agency ultimately approved 19 of the 20 devices. The FDA doesn’t require most medical devices to undergo testing on humans before they can be marketed.

In a 2011 survey conducted by the Union of Concerned Scientists (UCS) among the FDA’s Center for Devices and Radiological Health, more than one-quarter of the participants said they feel pressured to approve medical devices that they are not sure are safe.

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