House Panel Probes FDA's Criminal Investigations Office

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By Dana A. Elfin

Sept. 22 — Congressional Republicans want information from the FDA on efforts to improve the agency's criminal investigations office.

Leaders of the House Energy and Commerce Committee in a Sept. 20 letter asked the FDA for information about management and oversight at the agency's Office of Criminal Investigations. The letter, addressed to FDA Commissioner Robert Califf, asked the FDA to respond by Oct. 12.

Full committee Chairman Fred Upton (R-Mich.) and Oversight and Investigations Subcommittee chairman Tim Murphy (R-Pa.) signed the letter, which includes a request for arrest and conviction rates.

OCI, created in 1991, is the law enforcement arm of 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.

The committee 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 Office of Internal Affairs' (OIA) compliance with its investigative policies. The OIA is responsible for conducting investigations of alleged FDA employee misconduct.

The panel is also 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 OCI and OIA.

Law Enforcement/Regulatory Tensions

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

“That tension is one many law-enforcement agencies have to balance,” Ty E. Howard, of Bradley Arant Boult Cummings LLP in Nashville, Tenn., told Bloomberg BNA Sept. 22, “but it can be particularly tough with a hybrid agency such as the FDA.”

For example, Howard, a former state and federal prosecutor, said an early disclosure in an investigation that might serve FDA's regulatory function could potentially jeopardize a criminal investigation. The committee's questions about the timing of opening cases, procedures, and arrest and conviction numbers likely reflect the committee’s concern in this regard, Howard said.

“The letter reflects a concern over FDA OCI’s internal management and structure and, more broadly, about OCI’s mission and priorities,” he said.

“Overall, this appears to me to be appropriate congressional oversight to determine whether an agency is effectively and efficiently fulfilling its mission,” Howard said.

FDA Promises Response

When contacted for comment on the committee's letter, the FDA declined to comment on any specifics.

“The FDA has received the letter and will respond directly to the committee,” FDA press officer Lyndsay Meyer told Bloomberg BNA Sept. 22.

The Pharmaceutical Research and Manufacturers of America (PhRMA), the lobbying arm for the pharmaceutical industry, declined to comment on the letter.

GAO, OIG Reports

OCI operations were the focus of a 2010 Government Accountability Office (GAO) report and a 2012 report from the Department of Health and Human Services' Office of Inspector General.

The GAO report faulted the agency's oversight of OCI field offices and also criticized the agency for failing to have performance measures for OCI.

In 2012, the HHS OIG's report raised similar concerns, including that OCI and OIA were operating without sufficient oversight or accountability. The 2012 report also documented tension between OCI headquarters and OCI field offices over investigative priorities and case initiation, the letter said.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

A copy of the letter is available at

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