The FDA Spy Caper

Chuck Grassley, the Republican U.S. senator and Iowa farmer was, well, pissed off and practically spitting out his words during an interview with CNN on Monday, July 16.

“The agency doesn’t belong to them, ” said Grassley, “it belongs to the people of the United States.”

Targeted Electronic Surveillance

What got the normally calm Midwesterner all wound up was the news that the chief counsel’s office at the FDA had authorized email surveillance of a group of agency scientists that had gone to journalists, Congress, lawyers and the White House claiming that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.

According to a story in The New York Times on July 14, more than 80, 000 pages of computer documents were generated by the surveillance effort.

“The FDA’s actions represent serious impediments to the right of agency employees to make protected disclosures about waste, fraud, abuse, mismanagement, or public safety, ” wrote Grassley in a letter to agency. He demanded that the agency release a copy of the memo authorizing the surveillance and the name of the FDA official who requested it.

Erica Jefferson, an FDA spokeswoman, said that the agency is looking into the matter. She said that the surveillance was limited in scope and reiterated that it was relegated to government computers. “We did not impede or interfere with any employee communication to Congress, their staff, media or federal investigators, ” she said.

The Washington Post reported on July 17, that the FDA acknowledged that targeted surveillance of five employees began in mid-2010, but it said that was not ongoing today, according to a letter sent to Grassley by Jeanne Ireland, the agency’s assistant commissioner for litigation. The FDA said on July 16 that the computer surveillance was limited to five employees. But, according to the Post, an internal document shows that the agency targeted at least seven employees beginning in 2010.

The targeting of the employees’ communications, including e-mail and other online activities, was reported by the Post in January. The agency monitored personal e-mail accounts accessed from government computers, took electronic snapshots of computer desktops and reviewed documents saved on hard drives.

The Post story said the database was apparently posted inadvertently online by an FDA contractor included an FDA “scoping” document of targets for future e-mail interception that included congressional staff members. Also captured were draft complaints being prepared by the scientists to the Office of Special Counsel, an independent federal agency that investigates disclosures of government wrongdoing and retaliation against those who report it.

Privacy and Retaliation

At the heart of this lies the question of whether or not FDA employees have a right to privacy when using government computers and was the information used against those employees for the purpose of retaliation.

FDA computers post a warning to users, according to the Post, visible when they log on, that they should have “no reasonable expectation of privacy” in any data passing through or stored on the system, and that the government may intercept any such data at any time for any lawful government purpose.

Internal documents obtained under the Freedom of Information Act by the scientists, some of whom have been fired, show that the FDA was concerned that they had improperly disclosed confidential business information about the medical devices used to screen patients for colon cancer and breast cancer.

The scientists who were targeted in the FDA’s effort have filed suit against the agency for violating their privacy and right to free speech.

“Given the public health and safety nature of the concerns raised by these doctors and scientists, any authorization by the chief counsel would be startling, disturbing and should result in a swift investigation, ” said Stephen M. Kohn, an attorney for the scientists.