Congress’ Probe Could Mean End Is Near for FDA’s Office of Criminal Investigations


Congressional Republicans want information from the FDA on efforts to improve the agency's criminal investigations office and they want it fast.

Leaders of the House Energy and Commerce Committee, in a Sept. 20 letter, asked the FDA to provide information by Oct. 12 about management and oversight at the agency's Office of Criminal Investigations and sources tell me that this could be the first step in congressional efforts to get rid of the OCI entirely.

The OCI, created in 1991, is the law enforcement arm of the FDA, and its special agents arrest suspected parties, gather evidence and forward cases to the Justice Department or state court systems, as appropriate, for prosecution. It investigates criminal activities including counterfeit drugs and illegal drug marketing.

Off-the-record, my sources tell me that there have been some concerns that the OCI’s existence isn’t justified and that the cases it opens don’t necessarily reflect the agency’s overall priorities.

The committee is seeking FDA data on the number of arrests, convictions, new investigations and recovery amounts for fiscal years 2012 to 2015 and the number of full-time employees for the OCI and the Office of Internal Affairs.

It also wants to know whether the agency has implemented any of the several recommendations government watchdog agencies made in 2010 and 2012 to improve OCI's management, including instituting performance measures, establishing a case tracking system, addressing how cases are initiated, and assessing the OIA’s compliance with its investigative policies. The OIA is responsible for conducting investigations of alleged FDA employee misconduct.

The committee's probe into the OCI's operations illustrates the tension that exists between the FDA's overall mission to protect public health and safety and the OCI's law enforcement function.

Meanwhile, the FDA declined to comment on any specifics but said it would respond directly to the committee.

Stay tuned to see whether this congressional inquiry could be the proverbial nose under the camel’s tent in terms of restructuring law enforcement efforts at the FDA . . .

A copy of the letter is available at

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