FDA Insists It Only Spied on 5 Scientists

July 19, 2012 — -- The Food and Drug Administration denies that it targeted more than five of its scientists or any congressional staff, outside medical experts or journalists in a surveillance operation to identify who leaked confidential information to the media.

Sen. Chuck Grassley, R-Iowa, called on the Justice Department this week to investigate what he deemed the FDA's "targeted spy ring" after thousands of documents collected by the agency's monitoring software was surreptitiously posted online last week, allegedly by accident.

The documents, which were first reported by the New York Times, had been collected from the government-issued computers of five FDA scientists who alleged that the oversight agency was approving medical devises that expose patients to dangerous levels of radiation.

That trove of information suggested that the spying operation extended not only to the five scientists, but included a list of 21 FDA employees, congressional officials, outside medical researchers and journalists that were thought to be putting out "defamatory" information about the FDA, the Times reported.

FDA spokeswoman Erica Jefferson said the agency is investigating the "data breach" and that the "enemies list" that the Times reported was "merely an internal summary of who the employees were corresponding with."

Grassley said the documents, which were hastily taken offline last Friday, made the FDA "sound more like the East German Stasi than a consumer protection agency in a free country."

In the documents, the agency referred to whistleblowers as "collaborators," called congressional staffers "ancillary actors," and dubbed journalists "media outlet actors," Grassley said Tuesday in a statement.

Because the scientists were using federally-issued computers, the FDA could legally track any emails sent on them. The agency could not, however, specifically target emails between its staff and Congress, the Department of Justice and the staff members' attorneys.

"Secret monitoring programs, spying on Congress and retaliating against whistleblowers -- this is a sad commentary on the state of affairs at the FDA," Grassley said Tuesday on the Senate floor.

Jefferson denied that the agency targeted congressional communications.

"Neither members of Congress nor their staffs were the focus of monitoring," Jefferson said in the statement. "At no point in time did FDA attempt to impede or delay any communication between these individuals and Congress."

Only one of the scientists targeted by the FDA's spy software still works for the agency. The other four were either fired or their contracts were not renewed.

All five of the spied-on scientists are now suing the agency for violating their constitutional rights to privacy and for stealing their private information, such as passwords to online banking sites that could have been recorded by the monitoring software.

"There were no boundaries in FDA," said Stephen Kohn, the lawyer representing the FDA scientists. "What started as a leak investigation metamorphosed within weeks to an explicit campaign to intercept communications to Congress."

The FDA said that since their spy software recorded every keystroke, it was "incidential" that the passwords to the scientists' personal email accounts were collected. The FDA did not "utlize or otherwise take any action related to such passwords," Assistant FDA Commissioner for Legislation Jeanne Ireland said in a letter to Grassley.

Kohn said that in trying to prevent a handful of confidential documents from being leaked to the press, the FDA collected thousands of documents from the computers of its staff that were somehow made public.

"They were doing what they were accusing the whistleblowers of," he said. "They were violating confidentiality rules."

The alleged confidentially breaches started two years ago when the New York Times published an article citing information from FDA scientists about the agency nearing approval of CT scans for colonoscopies and mammograms.

In response to the March 2010 article, the FDA higher-ups asked the Department of Health and Human Services to investigate the scientists for illegally leaking classified documents. The department dismissed the investigation, saying the documents were legally given to reporters as "matters of public safety," the Times reported.

FDA took matters into its own hands in April 2010 and began spying on the five scientists, using surveillance software to capture every keystroke, record every email and take screen shots every five seconds. The authorization for the possibly illegal spying was "explicitly authorized, in writing" by the highest officers at the agency, according to Grassley's office.

After the Washington Post reported in January 2012 that FDA scientists were being monitored by the agency, Grassley requested information about the spying from the agency.

Seven months after that request, FDA commissioner Margaret Hamburg responded, saying her agency began the surveillance in order to protect "trade secrets" and "confidential commercial information" which if made public could "cause competitive harm to the company submitting the information."

Breaching confidentially could also land the FDA in a civil lawsuit and the agency's employees could be charged with criminal or monetary penalties, Hamburg wrote in the July 13 letter.

But Grassley refuted the FDA's claims that they were merely protecting confidentiality.

"The scope and tone of the surveillance effort reveals an agency more concerned about protecting itself than protecting the public, which ironically is the agency's mission," Grassley said Tuesday in a statement.