Lawmakers and Government Oversight Office Investigate FDA's Email Monitoring Program
The Washington Post recently reported on a lawsuit filed by six whistleblowers, who are former Food and Drug Administration scientists and doctors, accusing FDA of secretly reading their personal email accounts after they warned Congress that the agency was coercing them to approve medical devices that pose an unacceptable risk of harm to patients. The Complaint, which was filed in the United States District Court for the District of Columbia, alleges that FDA violated their constitutional rights, which ultimately led to harassment or dismissal of the six whistleblowers.
The challenged medical devices - most of which have been approved by supervisors despite their objections - include three devices that could miss signs of breast cancer, a devise that exposes patients testing for colon cancer to unnecessarily high levels of radiation (which can cause cancer in otherwise healthy patients), a device that risks falsely diagnosing patients with osteoporosis, and an ultrasound device used with pregnant women that could malfunction and harm the fetus.
FDA surveillance took place over a period of two years as the employees communicated with congressional staffers and their attorneys using personal Gmail accounts on government computers. FDA intercepted emails and draft whistleblower complaints containing information protected by the attorney-client privilege, and took snapshots of their computers.
Internal documents show that FDA reported the whistleblowers' conduct to the Office of the Inspector General in May 2010, stating that the whistleblowers had improperly disclosed confidential information about the devices and requesting that an investigation be opened. OIG declined to do so.
Among the communications intercepted by FDA were emails sent to the Office of Special Counsel, which was established by Congress to provide a secure and confidential avenue for whistleblowers to disclose government fraud, waste, and abuse, including health and safety issues. Recently, OSC broadened the scope of its investigation into the matter to determine whether FDA's surveillance and attempts to initiate criminal investigations against the whistleblowers violated the Whistleblower Protection Act. Under the Whistleblower Protection Act, federal employees are authorized by law to provide any information to OSC, including confidential information, to report government misconduct.
In a statement released by OSC, Special Counsel Carolyn Lerner said that "[m]onitoring employee emails with OSC of Congress could dissuade employees from making important disclosures" and is "unacceptable." She encouraged other agencies to "review their policies to ensure that they are not monitoring or otherwise impeding employee disclosures to OSC or Congress."



