On July 23, 2012, a federal judge ordered the U.S. Food and Drug Administration to turn over previously undisclosed documents to attorneys for former and current employees of the FDA who claim that the FDA illegally spied on them after they reported allegedly improper medical device approvals by the FDA to the U.S. Congress. The employees allege that the FDA intercepted their emails from their personal e-mail accounts that were transmitted over agency networks, which began three years ago after nine FDA employees signed a letter they delivered to President Obama’s presidential transition team alleging that there was governmental misconduct in the FDA’s approval of medical devices, including an imaging device used in breast cancer screening.
Additionally, after an article appeared in the New York Times in 2010 that described FDA scientists’ criticism of the FDA’s medical device approval process, the FDA allegedly expanded its surveillance of the employees’ private e-mails.
The federal judge’s order in the Freedom of Information Act lawsuit that parallels the employees’ separate civil rights lawsuit requires the FDA to turn over 4,000 pages of surveillance-related documents sought by the employees by August 24, 2012, with the remaining requested documents produced by September 10, 2012. Congress and the U.S. Office of Special Counsel have also been investigating the alleged spying by the FDA.
The civil rights case is captioned Hardy v. Shuren, Case No. 11-01739, and the Freedom of Information Act case is captioned National Whistleblower Center v. Department of Health and Human Services, Case No. 10-CV-02120, both of which are pending in the U.S. District Court for the District of Columbia.
Source: The Daily Record, July 24, 2012.
All of us should be concerned that the federal agency whose mandate is to prevent defective and dangerous drugs and medical devices from entering the supply stream in the United States allegedly engaged in secret and illegal spying of its own employees who brought their concerns about agency misconduct that may have endangered members of the public to the attention of the U.S. Congress and other investigative entities.
While one would expect that federal employees would use proper and approved channels to voice their concerns about alleged misconduct within their agencies that may harm the public, one would also hope that the integrity and moral compass of those whose job is to supervise FDA employees who are responsible to protect the public from harms that may be caused if dangerous or defective products gained FDA approval under questionable circumstances would temper their efforts to investigate and punish employees who “go public” in violation of agency policies.
Public employees (those employed by the federal government, as well as state and local governments) are unlike private company employees in that public employees work for us — their jobs are to protect us and to further the public’s interests. When public employees become aware of their agencies’ serious misconduct or wrongdoing that poses an immediate and substantial danger to members of the public, then who can fault them for contacting members of the U.S. Congress, which has authority and investigative power over many federal agencies, with their concerns that are not being timely or properly addressed by their respective agencies (we are not suggesting that sensitive, confidential, secret, or personal/private information should be readily disclosed in violation of federal agency or U.S. government requirements).
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