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John O’Sullivan
2 months ago
Lawsuits filed by six whistleblowers from within the Food and Drug Administration (FDA) claim the regulatory agency monitored their emails and communications with Congress regarding the procedures bypassed to get new medical devices on the market faster. According to several reports, the accusations made by these whistleblowers raise questions about the true aim of the […]
Lawsuits filed by six whistleblowers from within the Food and Drug Administration (FDA) claim the regulatory agency monitored their emails and communications with Congress regarding the procedures bypassed to get new medical devices on the market faster.
According to several reports, the accusations made by these whistleblowers raise questions about the true aim of the FDA, the scope of Big Brother and overall treatment of whistleblowers. The news has sparked an investigation from Sen. Charles Grassley (Rep., Iowa), a Ranking Member of the Senate Judiciary Committee.
In a release announcing Grassley’s investigation, the Senator said the whistleblowers first sent a letter to President-Elect Barack Obama’s Transition Team office, notifying the soon-to-be President of the FDA’s definition of oversight and who it was really overseeing. Collectively, the whistleblowers accuse the agency of monitoring personal communications (including phone calls and emails) between themselves and some members of Congress, including Sen. Grassley.
The emails and other communications intercepted or monitored by the FDA dealt with the ignorance of critical safety data on several new medical devices, information that, if it remains hidden from the public, could result in serious injuries or death. A New York Times editorial identifies these medical devices as those used to detect colon and breast cancer, as well as other diseases.
The currrent and former employees and contractors included in the lawsuit filed last week against the agency were hired as scientists and physicians by the FDA to help mitigate safety data on new device approvals.
As an initial part of the investigation, which was also prompted in part due to the release of information from the National Whistleblowers Center, Grassley has asked FDA Commissioner Margaret Hamburg whether the six whistleblowers were “singled out” by the agency because of their doubts concerning these devices.
The executive director of the National Whistleblowers Centers, Stephen Cohn, said in a statement the agency is overstepping the bounds of its employee surveillance policy. “They unconstitutionally targeted one group of employees simply because they had the guts to speak up about misconduct.”
The group also said that intimidation of public employees has a “chilling effect” on others employed by any form of government. Knowledge that they could be watched, monitored or followed likely would deter any would-be whistleblower from speaking out about suspected misconduct by any government agency.
To target these whistleblowers, who’ve filed a lawsuit against the agency last week, the FDA installed spyware and other monitoring software of their computers. This allowed them to read password-protected emails sent from Google email accounts. The software also enabled the FDA to take screenshots of employee computers.
The FDA has previously attempted to bring criminal charges against the whistleblowers but to no avail. Despite this, the FDA continued to monitor these employees.