House Committee Leaders Want OCI Update

Reps. Fred Upton (R-MI), chairman of the House Energy and Commerce Committee, and Rep. Tim Murphy (R-PA), who heads the committee’s Oversight and Investigations Subcommittee, are asking (includes link to committee letter) FDA for an update on its Office of Criminal Investigations (OCI) in the wake of information from independent watchdogs that identified weaknesses in the organization. OCI also has been the subject of a Reuters investigation.

“Two independent reports, one from the Government Accountability Office (GAO) in 2010 and one from the Department of Health and Human Services Inspector General in 2012, have identified OCI management issues and made recommendations for improvements,” the two lawmakers wrote FDA commissioner Robert Califf. “The GAO report on FDA OCI found that FDA maintained limited oversight of the investigations conducted by OCI and lacked sufficient performance measures. The GAO report also raised concerns about the OIA (Office of Internal Affairs), a component of OCI comprised of OCI detailees, responsible for conducting (sic) internal allegations of misconduct by FDA employees.”

The letter to Califf says the committee is concerned about OCI’s management and possible morale issues with field offices. It asks for this information: 

•          If FDA implemented a GAO recommendation for performance measures for OCI’s criminal investigative program and assessed the program results against them. If so, it asks for the performance measures and results, and whether the results showed if the OCI criminal investigative program is achieving its results.
•          How FDA has addressed concerns about OCI case initiation procedures.
•          What is FDA’s existing policy for conducting regular assessments of OCI field offices? What regular assessments has FDA conducted of OCI field offices since 1/1/12? What field offices were assessed? What subjects were covered by the assessments? Who conducted the assessments? What is involved in the assessment process?
•          Did FDA implement a GAO recommendation to establish a review procedure to assess Office of Internal Affairs compliance with its investigative policies? If so, what actions were taken?
•          Has FDA established a procedure authorizing domicile offices? If so, provide documentation stating the procedure.
•          What is the justification for allowing the OCI director to have a duty station and work at the OCI Miami field office? Provide all applicable documentation to support the arrangement, including agency telework agreements, OCI domicile office location approval from OCI headquarters, and official duty station paperwork. Also provide any internal assessments used to justify the management model of the OCI director working from the Miami field office with headquarters staff remaining at the Rockville, MD, headquarters.
•          FDA has stated to the committee that “OCI, as part of FDA, has an overriding responsibility to protect the public health and safety, which is often jeopardized by crimes involving FDA-regulated products. In OCI investigations, protection of the public health is paramount, even at the expense of the criminal investigation, if necessary.” How do the OCI’s case initiation procedures reflect these values? What is the process for OCI to open a criminal case? How many average days does it take to open a criminal case? Does OCI have any expediting procedures for opening cases where there is a public health exigency such as product tampering?
•          For FY 2012-2015, please provide number of arrests, number of convictions, number of new investigations opened, and amounts of recoveries.
•          Provide the number of current full-time equivalent employees for OCI and OIA.
•          Provide a copy of OCI’s performance plan and/or work plan for FY 2016.
•          Has FDA established a system to enable Centers to identify which products and product types are currently under investigation? If so, describe the system and when it was established.