Regulatory Focus™ > News Articles > Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices

Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices

Posted 16 July 2012 | By Alexander Gaffney, RAC 

An investigation into the US Food and Drug Administration (FDA) by The New York Times has revealed the agency established an extensive monitoring program aimed at both restricting leaks of confidential information and establishing what The Times refers to as "an enemies list of sorts."

The agency is currently under investigation--and is being sued by--various groups who allege the agency spied on its own employees, violating both whistleblower protection laws and violating constitutional protections.

An FDA contractor, Quality Associates Inc, was reportedly charged with obtaining documents related to a lawsuit and making them available to all parties of the lawsuit. In the process of releasing them, however, The Times reports the contractor inadvertently released more than 80,000 previously-unreleased documents to a publicly-available website, detailing both the agency's investigation into whistleblowing by some of its own employees and other proprietary information related to several medical devices.

A review of the documents confirmed many of the facts first reported in January 2012 by a Washington Post investigation.

"The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the [several FDA] scientists as they were being used at work or at home," The Times explained. "The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show."

Statements by FDA

The release of the information prompted FDA to release a statement to the press indicating its monitoring program was "limited and intended to determine whether confidential commercial information had been inappropriately released to the public," and did not focus on members of Congress or their staffs.

"The FDA's ability to protect and promote public health in the U.S. is tied to our ability to protect confidential information," continued FDA. "This allows us to work with industry to ensure the quality of FDA-regulated products and also encourages outside stakeholders to provide us with information that would allow the agency to identify any wrongdoing."

The statement itself is rare, as the agency typically does not comment on matters related to pending litigation.

Additional remarks by John Taylor III, counselor to FDA Commissioner Margaret Hamburg, this weekend seemed to indicate the program was overseen personally by Dr. Jeffery Shuren, of FDA's Center for Devices and Radiological Health (CDRH).

"We have a legal duty to investigate disclosures of confidential information," Taylor said in an interview with the Wall Street Journal on 15 June. "Dr. Shuren made sure there was adequate investigation of the allegations of the whistle-blowers."

Lawsuit Seeks Additional Information

The release of the information comes at an awkward time for FDA, which is presently being sued in the US District Court in Washington, DC over allegations that it spied on at least nine of its employees within CDRH.

Several of the nine employees are represented by The National Whistleblowers Center (NWC) and its Executive Director, Stephen Kohn. In an interview with Regulatory Focus on Friday-one day before The Times released its story-Kohn called FDA's actions "retaliatory and improper."

"FDA's actions are absolutely nefarious," Kohn said, adding his group wants to know "what types of tactics are being used by the government to spy on its employees."

The NWC has filed a Motion for Preliminary Injunction seeking to compel FDA to comply with a Freedom of Information Act (FOIA) request "for records concerning the warrantless surveillance program" the agency allegedly used against its own employees. "Specifically, [NWC] requests documents related to the Department of Health and Human Services' (DHHS) policy of conducting covert, warrantless surveillance of whistleblowers' private email correspondence." DHHS is FDA's parent agency within the federal bureaucracy.

While the group had originally planned to hear back from the court in June, its hearing before the DC District Court has been rescheduled until 23 July. The accidental release of documents related to the case, which appear to have gone far beyond what the group was asking for in court, could potentially complicate FDA's defense and ability to keep the documents from the public.

"The conduct by FDA managers, designed to undermine a group of doctors and scientists who reported significant health and safety violations, is deplorable," said Kohn after the release of The Times' article. "Those involved must be held accountable."

The group explained they already have "a limited number of documents that show the FDA conducted special targeted monitoring of employees who blew the whistle on misconduct and inappropriate approvals of unsafe medical devices."

"The FDA activated spyware on whistleblowers' work computers to spy on their password protected Gmail-to-Gmail correspondences to Congress, the Office of Special Counsel and other oversight authorities," NWC wrote.

Congressional Pressure Intensifies

The Times' report also details evidence of an "enemies" list within FDA-"unusual at domestic agencies that do not handle classified information," it noted. The documents detailed efforts to fire employees within the agency that had gone public with complaints, attempts to track contacts with members of the media, get in front of potentially damaging stories by assessing which members of its staff were contacting media outlets and rank members of congress deemed to be unfriendly towards the agency.

Some members of Congress-just days after approving a massive bill to reform FDA-were furious at FDA.

"[FDA has] absolutely no business reading the private e-mails of their employees," Said Senator Charles Grassley (R-IA). "They think they can be the Gestapo and do anything they want."

"[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," remarked Representative Chris Van Hollen (D-MA), who found himself ranked as an "ancillary actor" on one of FDA's lists.

An Expanding Investigation

The entire case stems from a January 2012 lawsuit filed by six former FDA staff members within the agency's medical device review group who alleged they were spied upon and retaliated against after they raised concerns about the safety of devices reviewed and approved by the Center for Devices and Radiological Health (CDRH).

The investigation almost immediately garnered the attention of Grassley, who, along with Rep. Darrel Issa (R-CA), launched a Congressional investigation into the matter.

"It's hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their email accounts for legally protected communications with Congress," said Grassley in a statement in January.

In a February letter to FDA Commissioner Margaret Hamburg, Grassley said the entire saga had thus far left him with concerns. "It is troubling to me to see your Agency actively pursue the dismissal of an employee against the advice of the Office of Special Counsel (OSC)-not because they violated procedure and leaked genuinely confidential classified information, but simply because you 'cannot trust him,'" wrote Grassley in his letter to Hamburg.

The OSC is a federal agency tasked with protecting whistleblowers within government and has investigative and prosecutorial powers.

Grassley and Issa would issue another letter to FDA in March seeking information about the burgeoning scandal, and OSC opened its own investigation in March. OSC also issued guidance in June seeking to limit the use of email monitoring-guidance almost specifically tailored to FDA's alleged actions.

Grassley, for his part, has expressed his frustration with what he sees as a lack of response from FDA thus far. In a 14 June letter to FDA, Grassley said Hamburg had failed to deliver on promises to make available documents related to the case.

"After four months of pushing on our end, at last, the FDA commissioner herself indicated that an FDA response was on the way," wrote Grassley in a statement posted on his website. "Then the FDA abruptly switched gears and said an unnamed official in the Administration is reviewing the response.  That leaves the response in limbo."


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