Regulatory Focus™ > News Articles > Regulators, Contractor in Spat Over Accidental Release of Documents

Regulators, Contractor in Spat Over Accidental Release of Documents

Posted 25 July 2012 | By Alexander Gaffney, RAC 

US regulators and health officials are currently engaged in a 'he-said, she-said' argument with a federal contractor over how nearly 80,000 documents related to a surreptitious surveillance program and potentially confidential industry information were published to an unsecured website, reports The Washington Post.

The matter stems from a July 2012 report from The New York Times, who, along with lawyers from the National Whistleblowers Foundation, had discovered the trove of records through an online Google search of the name of a former employee of the US Food and Drug Administration (FDA) engaged in a lawsuit against the same agency. The report immediately set off a firestorm of criticism from legislators, public advocacy groups and journalists, and raised questions regarding how the information came to find its way online in the first place.

Subsequent reporting by The Wall Street Journal revealed the contractor in question was Quality Associates Incorporated, a Maryland-based contractor reportedly charged with making documents available to parties engaged in litigation.

A 24 July report by The Post sheds additional light on how those documents came to be public in the first place. Quality Associates reportedly released documents to congressional investigators within the past few days detailing that a government work order said the released documents were clear of any "classified, sensitive or personal information."

This, however, was not the case. The files contained intercepted-and potentially confidential and legally protected-communications between FDA employees and various outside agencies, as well as confidential medical device data and information reportedly linked to General Electric.

An Emerging Mini-Scandal

The release of the documents is becoming a scandal unto itself, with Senator Charles Grassley (R-IA) calling on government agencies, including FDA, to disclose how the documents were made public.

"Federal agencies have a responsibility to handle documents carefully," Grassley wrote in a public statement.  "Agencies should know when they are releasing internal documents to the public and should do so deliberately, with appropriate protections for truly private information, rather than merely hiding details about the public's business from the public.   It's not clear from this incident whether the agencies were looking for any sensitive materials before shipping files over for archiving and possibly inadvertent public distribution."

The potentially embarrassing episode-and the added congressional scrutiny-is leading to finger-pointing between FDA and Quality Associates, reports The Post.

Quality Associates' CEO Scott Swidersky told the paper his company was just following the agency's directives when the documents were made public. "In the case of the FDA, if they're not informing us otherwise, then we're simply moving the data along" Swidersky said in an interview with The Post. "Our role is very, very limited." Data passed on from the agency is not looked at by the company, he added.

FDA officials meanwhile told The Post the company was not authorized to publish the documents online, and placed blame on Department of Health and Human Services (DHHS) officials for the lapse. "We are continuing to investigate the unauthorized disclosure of these documents," FDA wrote in a statement.


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