WASHINGTON Feb 26 The U.S. Food and Drug
Administration exceeded its authority when it set up a
surveillance program to monitor employees in its medical device
division who it suspected of leaking trade secrets, two
prominent Republican lawmakers said on Wednesday.
The charge was made in a report released by Representative
Darrell Issa, chairman of the House oversight panel, and Senator
Charles Grassley, the ranking Republican on the Senate Judiciary
It followed a two-year investigation initiated after The New
York Times reported on the surveillance in 2012.
The report found that the FDA may have broken laws
protecting whistleblowers and that interim policies put in place
by the agency last year to safeguard them were insufficient.
FDA spokeswoman Erica Jefferson said in a statement that the
agency had not been given an opportunity to review the full
report but said "many of the findings outlined paint an
incomplete picture of the matter."
In April 2010, the FDA engaged contractors to check on
first one scientist and then four more using a software
monitoring program called Spector 360, the report said.
The surveillance followed media reports that the agency had
ignored warnings from FDA scientists about the potential health
risks of radiation exposure associated with some medical
"FDA officials were able to obtain sensitive information and
protected communications, including attorney-client
communications, communications with Congress, and communications
with the OSC," the report said, referring to the Office of
Special Counsel which protects government employees from
reprisals for whistleblowing.
"Federal law protects disclosures to OSC and Congress," it
The FDA's Jefferson said the agency did not target,
intercept or prevent any communications to Congress or retaliate
against medical device division scientists for their complaints
She said the FDA and the U.S. Department of Health and Human
Services, under which it falls, "have robust protections in
place for whistle blowers, including an Ombudsman, and for
removing protected information from any investigation."
Issa's House Committee on Oversight and Government Reform
was due to hold a hearing the matter on Wednesday.
The DHHS's internal watchdog, the office of inspector
general, released a report on Tuesday, that found that the FDA
had reasonable concern that confidential information had been
disclosed. It said the agency had notified its scientists
through a network log-on banner that there was no right to
privacy on its computer network.
"We found no evidence that FDA had obtained or used
passwords to any of the scientists' private email accounts," the
report said, "nor did we find any evidence that FDA logged into
any of the scientists' computers in order to gain live access as
a user of the computer."
Still, OIG found that there was no policy in place to ensure
that use of the monitoring devices complied with the law and
said the agency should have obtained legal advice before using
The FDA's Jefferson said the agency agreed with the OIG's
recommendations and had already taken additional steps to
enhance its monitoring procedures to ensure that "if necessary
it is done in a matter that protects protected information."