WASHINGTON, Feb 26 (Reuters) - 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 Committee.
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 devices.
“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 said.
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 to Congress.
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 them.
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.”