FDA officials surreptitiously tracked and archived tens of thousands of personal emails sent to non-FDA-affiliated individuals and the media by former and current scientists and staff regarding concerns about the agency's medical device review and approval processes, the New York Times reports.
More than 80,000 pages of documents were generated during the secret surveillance effort, which included communications involving 21 FDA employees with members of Congress, lawyers, labor officials, journalists and even President Obama, the Times reports.
According to the Times, the surveillance began in mid-2010 after a routine agency investigation into complaints by the scientists, who alleged that FDA was using faulty review procedures for the approval of certain medical imaging devices (Lichtblau/Shane, New York Times, 7/14).
Background on the Case
In January, six current and former FDA scientists and physicians filed a lawsuit alleging that FDA monitored their personal email after they warned congressional staffers that the agency approved medical devices that might pose risks to patients.
According to government documents gathered by the plaintiffs, FDA started intercepting personal emails between several of its employees and congressional staffers in January 2009 and continued the surveillance for two years. FDA also took screenshots of the employees' computer desktops and reviewed documents that they had saved on their hard drives (iHealthBeat, 2/17).
FDA Defends Email Tracking Effort
FDA officials acknowledged that the secret computer-monitoring effort involved members of Congress, journalists and other individuals, but added that it was limited to communications from five scientists whom they suspected of leaking confidential information about the safety and design of medical devices, the Times reports. The documents generated do not identify who at FDA authorized the surveillance effort or whether it still is ongoing.
FDA officials said the surveillance effort was not intended to impede scientists' communications with external entities and individuals.
After Obama administration officials learned about the extent of the surveillance, the White House Office of Management and Budget last month sent a memo detailing federal policy on such programs. The memo stated that internal monitoring of communications is permitted, but it must be conducted in ways that "do not interfere with or chill employees' use of appropriate channels to disclose wrongdoing."
According to the Times, FDA's program might have tracked, archived and analyzed confidential information that specifically is protected under federal law, including attorney-client communications, whistleblower complaints to Congress and workplace complaints filed with the government (New York Times, 7/14).
Lawmakers Angered by Surveillance Program
Members of Congress raised concerns over the monitoring, noting that the documents included communications with their offices, Reuters/Hartford Courant reports.
Rep. Chris Van Hollen (D-Md.), whose name and those of his staff surfaced in the documents, said, "It is absolutely unacceptable for the FDA to be spying on employees who reach out to members of Congress to expose abuses or wrongdoing in government agencies."
Sen. Chuck Grassley (R-Iowa) -- who also was identified in the emails -- said, "The FDA has a lot of explaining to do in the weeks ahead" (Lange et al, Reuters/Hartford Courant, 7/15). Grassley said FDA "is discouraging whistleblowers," and added that officials "have absolutely no business reading the private emails of their employees. They think they can be the Gestapo and do anything they want" (New York Times, 7/14).
FDA Investigates Leak
In related news, FDA officials said the agency is investigating how the tens of thousands of documents that were generated as part of its main investigation into the scientists' complaints were made available to the public, the Wall Street Journal reports.
According to the Journal, FDA gave an external contractor -- Maryland-based Quality Associates -- access to the files so it could print the documents and distribute them to various parties involved in the lawsuit that the scientists filed against FDA. FDA officials said that the files were available online for several days in May but that they since have been removed (Burton, Wall Street Journal, 7/15).