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FDA Surveillance of Medical Device Employees Posted Online

FDA Surveillance of Medical Device Employees Posted Online

July 16, 2012 — The U.S. Food and Drug Administration (FDA) is being sued by six employees who found out they were being monitored by their employer as they worked with journalists and Congress to expose problems with the FDA’s approval of medical devices. The FDA defended itself by saying that they had to ensure the disgruntled employees were not sharing trade secrets from new medical devices. Now it appears that the FDA accidentally posted the hour-by-hour surveillance on a public website, and New York Times journalists have reviewed the records.

The scientists were employed in an office charged with overseeing the approval of radiological devices. They originally voiced their concerns in 2007, when twelve radiological devices were approved against the recommendations of doctors and scientists within the agency. Some of the devices could miss signs of cancer, misdiagnose osteoporosis, or deliver high doses of radiation that could cause cancer.

The FDA responded by placing surveillance software on the employees’ laptop computers, which were used at work and at home. The software logged keystrokes, collected passwords, intercepted emails, copied documents on thumb drives, took periodic snapshots of the screen, and sent alerts when certain keywords were entered.

This software is mostly used by the U.S. military and intelligence agencies to monitor employees who may leak national secrets. It is very unusual for a public agency to use this type of surveillance against its own employees.

The agency has defended its actions by saying that they were only trying to ensure that the employees were not sharing trade secrets about the devices they were reviewing.

For more than two years, the FDA collected 80,000 pages of documents from 21 agency employees and their correspondents, including Congressional officials, medical researchers, and journalists.

According to the New York Times,

“The documents captured in the surveillance effort — including confidential letters to at least a half-dozen Congressional offices and oversight committees, drafts of legal filings and grievances, and personal e-mails — were posted on a public Web site, apparently by mistake, by a private document-handling contractor that works for the F.D.A. The New York Times reviewed the records and their day-by-day, sometimes hour-by-hour accounting of the scientists’ communications.”

In January this year, the scientists filed a lawsuit against the FDA, alleging that the agency illegally monitored their private communications and fired them as a way to quell a whistleblower lawsuit and criticism of the FDA’s approval of medical devices.

The government has sent a notice that employers are allowed to monitor employees’ activities on work computers, but they are not allowed to intimidate whistleblowers.

In recent years, there has been growing criticism of the FDA’s system for approving medical devices. There have been numerous high-profile incidents where the FDA approved a device that later caused thousands of severe injuries. Examples include metal-on-metal hip implants, transvaginal mesh, brain stents, gastric bands, and more. Some of these devices were approved through the 510(k) approval system, which allows manufacturers to avoid conducting expensive, lengthy safety studies so long as they claim their device is “similar” to an existing device.

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