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Regulatory Focus™ > News Articles > Senator: FDA Stonewalling Investigation into Secret Monitoring

Senator: FDA Stonewalling Investigation into Secret Monitoring

Posted 14 June 2012 | By Alexander Gaffney, RAC 

Senator Charles Grassley (R-IA) is not pleased with the US Food and Drug Administration (FDA). Grassley, who serves on the Senate Judiciary Committee, has been investigating FDA for months after allegations were raised about the agency's handling of a whistleblowers within its medical device reviewing group, and whether the agency intercepted communications between  the whistleblowers and Congress.

But those months have borne little other than frustration for Grassley, who said in a statement that FDA seems to be stonewalling him with a lack of cooperation.

The entire incident stems from a lawsuit filed in January 2012 by six former employees of FDA's Center for Devices and Radiological Health (CDRH). The employees, all reviewers within CDRH's Office of Device Evaluation (ODE), had all separately raised concerns about the safety of some devices under their review around 2007. After their concerns were either allegedly rebuffed or ignored, the reviewers sent their concerns to Congress, which obtained significant amounts of media attention after they were publicized.

The disclosure did not sit well with FDA management, allege the former employees, and the agency soon after placed their communications at the agency under surveillance. Among the communications surreptitiously intercepted by FDA included further communications with Congress, allege the six, whose lawsuit charges FDA with unlawfully monitoring personal and protected communications.

The allegations brought swift attention from Grassley, who at the time said FDA's purported behavior was not a good use of staff resources. "It's hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their email accounts for legally protected communications with Congress," said Grassley in a statement.

Grassley and Representative Darrell Issa (R-CA), Chair of the House's Oversight Committee, also expressed concern about the intercepted communcations in a letter later sent to the Office of Management and Budget's Jeffery Zients. "To the extent that it monitored communications with the Congress and the Office of Special Counsel (OSC), the FDA was not legitimately investigating wrongdoing or tracing a security breach," the two wrote.

While FDA refused to comment on the lawsuit, FDA Commissioner Margaret Hamburg shed some light on FDA's views towards the approach in a February interview with National Public Radio's Michael Krasney.

"There's a lot of misinformation that is out there and circulating," said Hamburg. "At FDA, we take very seriously the responsibility to protect commercial and confidential information, and at FDA we do follow established guidelines and a legal framework for protecting certain kinds of data from inappropriate use and inappropriate distribution."

"FDA employees, when they sign on to their computers, are made aware about the possible monitoring of information. They don't have an assurance of privacy on certain types of communication," said Hamburg, who declined to discuss the specifics of the case during the interview.

According to Grassley and his staff, Hamburg also promised to release to his office a full response to his concerns within short order.

"After four months of pushing on our end, at last, the FDA commissioner herself indicated that an FDA response was on the way," wrote Grassley in a statement posted on his website. "Then the FDA abruptly switched gears and said an unnamed official in the Administration is reviewing the response.  That leaves the response in limbo."

"This puts us back to square one, and it's not a good development from an Administration that was supposed to be the most transparent in history," concluded Grassley.

An FDA spokeswoman, Erica Jefferson, told The Post the agency will be responding to Grassley "directly," though no time frame for the response was provided.

Read more:

The Washington Post - Sen. Charles Grassley says he is getting no answers from FDA on staff monitoring

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