Bloomberg News

FDA Accused of Spying on Staff Over Complaints to Congress

February 03, 2012

(Updates with details from filing in third paragraph.)

Jan. 30 (Bloomberg) -- U.S. Food and Drug Administration employees accused the agency spying on staff members who told lawmakers it was improperly approving medical devices used to screen for cancer.

The allegations include the interception of e-mail from personal accounts sent across agency networks. The claims were added last week to a civil rights lawsuit filed by current and former agency employees in September in federal court in Washington against FDA officials and the Health and Human Services Department.

The employees said the agency monitored their communications using spyware to capture screen shots and learn the workers’ identities, as well as “the tactics and strategy,” they were planning to use in “blowing the whistle to Congress, the inspector general, among other proper authorities,” according to the filing.

The monitoring began three years ago, after nine FDA employees signed a letter to President Barack Obama’s transition team alleging government misconduct in the approval of medical devices, including an imaging device used to diagnose breast cancer, according to the filing. It was expanded in 2010 after the New York Times published an article in which FDA scientists criticized the device-approval process.

‘For Congress’

“The information secretly obtained by defendants included plaintiffs’ legally protected documents and information that was stored by plaintiffs in folders labeled ‘For Congress’ and other folders that clearly indicated the intent of plaintiffs to raise issues of public concern with appropriate authorities,” according to the Jan. 25 court filing.

Details of the Jan. 25 filing were reported earlier by the Washington Post.

The lead plaintiff in the case is Paul Hardy, a former officer of the U.S. Public Health Service Commissioned Corps. The other plaintiffs are three former FDA scientists -- Ewa Czerska, Robert Smith and Julian Nicholas -- and two current FDA employees -- R. Lakshmi Vishnuvajjala and Nancy Wersto.

Erica Jefferson, an FDA spokeswoman, said the agency doesn’t comment on litigation.

Bolster Scrutiny

A government report found the FDA required extensive testing for less than one-10th of about 13,500 devices it cleared from 2003 to 2007. The 2009 Government Accountability Office examination of the device-review process called on the agency to bolster scrutiny of products that pose the greatest risk.

The FDA lets most devices reach the market through a less stringent approval process that doesn’t require human testing. After the 2009 report, the agency granted expedited reviews to at least 67 “high-risk” devices, including pacemakers and artificial hips, according to testimony to Congress in April by the GAO.

The Institute of Medicine, the scientific advisers to the nation, suggested in July that the FDA scrap expedited review for devices that pose greater risk. The agency disagreed.

The case is Hardy v. Shuren, 11-01739, U.S. District Court, District of Columbia (Washington).

--With assistance from Anna Edney in Washington. Editors: Andrew Dunn, Charles Carter

To contact the reporter on this story: Tom Schoenberg in Washington at tschoenberg@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.


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