As scrutiny intensifies over a sprawling surveillance program the Food and Drug Administration carried out against its own employees, a top Republican senator alleges the controversy goes at least as high as the chief counsel's office.
Sen. Charles Grassley, R-Iowa, claimed in a letter to the FDA commissioner this week that, despite the agency's refusal to say who authorized the spying against agency doctors who had complained about medical device safety, the senator's office can confirm it was "explicitly authorized" by the General Counsel's Office.
Grassley also accused the FDA of monitoring "communications with Congress" and punishing whistleblowers, and said he was referring the case to the Justice Department for "further investigation."
"FDA's misconduct cannot be ignored," Grassley wrote.
The stern letter from Grassley is the latest development in the rapidly evolving controversy concerning a surveillance program the FDA enacted against several agency doctors. Though Grassley is pressing for more information, the FDA acknowledges that it monitored a group of five employees starting in 2010.
That surveillance was extensive.
After installing monitoring software on the targets' computers, the FDA began collecting volumes of data. This included screenshots, "taken every five seconds," of whatever was on their computer monitors; all email traffic; all network activity; all data stored on and printed from the computers; and "all keystrokes."
The New York Times recently reported that the internal investigation into five scientists, though, grew into a bigger campaign to monitor critics -- the Times reported that the agency had a database of more than 80,000 pages from the monitoring campaign. According to the Times, the campaign actually flagged 21 employees, congressional officials and others thought to be putting out "defamatory" information about the FDA. The dispute reportedly sprouted from scientists' complaints that medical devices exposed patients to radiation following improper agency reviews.
In a July 13 letter to Grassley, FDA Assistant Commissioner for Legislation Jeanne Ireland defended the agency's practice.
She noted that the FDA "has important obligations to ensure the integrity of the medical device premarket review process." For instance, she said disclosure of "trade secrets" and other commercial information could "cause competitive harm" to companies they are dealing with. She cited a letter they received from GE Healthcare's counsel in April 2010 claiming the FDA had disclosed confidential information from one of its submissions.
Despite concern from Grassley that the FDA was flagging communications with Congress, Ireland wrote that the FDA knew of communications with Congress as far back as October 2008, yet didn't start monitoring employees until 18 months later. "The impetus for the monitoring was not any communication to Congress," she wrote.
However, Grassley decried Ireland's response as "incomplete and misleading."
For one, he said a so-called "scoping document" targeted "future communications with Congressional offices for interception." He said screen shots taken by the agency included emails from his committee staff and that of Rep. John Dingell, D-Mich.
"I have reminded FDA in the past that interfering with a Congressional inquiry is against the law, that denying or interfering with employees' rights to furnish information to Congress is also against the law," Grassley wrote, before saying he's handed the documents he has over to several federal offices including the Justice Department.
Scientists targeted by the FDA are suing the agency, though the FDA maintains its employees are "subject to monitoring of their use of government-owned equipment" in accordance with federal law.