Within the Food and Drug Administration (FDA) is the Office of Criminal Investigations (OCI), which investigates individuals and companies external to FDA. In addition, FDA also has the authority to investigate allegations of FDA employee misconduct through internal investigations conducted by the Office of Internal Affairs (OIA), a distinct office within OCI. Over the last decade (1999 to 2008), the Government Accountability Office (GAO) was asked to examine three particular areas within these offices:
– oversight of OCI investigations;
– oversight of OIA investigations; and
– funding, staffing, and workload for OCI.
In order to carry out this study, GAO interviewed agency officials, reviewed FDA documents including those describing its investigative policies, and examined FDA data on OCI resources and workload, from fiscal years 1999 to 2008. The final report, which was recently issued, is titled “Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations.” The report found that:
– FDA's funding for OCI generally increased annually between fiscal years 1999 and 2008 ($19 million in fiscal year 1999 to over $41 million in fiscal year 2008, a 73% increase);
– FDA’s staffing for OCI increased by about 40 percent during this period, from about 165 full-time equivalent employees to over 230;
– OCI's investigative workload also increased 27 percent over this 10-year period;
– the number of cases that OCI’s criminal investigators actively worked at the end of a fiscal year increased by 66 percent, from 655 to 1087; and
– Of the 24 total office assessments that should have been completed by August 2009, only 7, or about 30 percent, were completed and one office had not been assessed in over 10 years;
One of the issues that GAO found was that although OCI has policies to guide its investigations of individuals and companies external to FDA, FDA’s oversight of OCI’s criminal investigations is limited. In particular, FDA has not ensured OCI’s compliance with investigative policies and procedures within prescribed time frames. Additionally, the report found FDA lacks performance measures that could enhance its oversight of OCI by allowing it to assess OCI’s overall success. For example, there is no requirement for OCI to report regularly on specific topics to FDA senior-level offices as part of the formal reporting relationship, leaving the OCI Director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management.
According to the OCI Director, some of these issues occur because of limited resources and logistical issues, which have prevented FDA from assessing field office compliance with OCI’s investigative policies and procedures every 3 years. Another reason why OCI has little control over the outcome of cases is because investigations priorities often affect staffing and resources within a U.S. Attorney’s Office and may indirectly affect the ability of the office to proceed on every matter presented for prosecution.
Discussion
In response to the report, Senator Charles Grassley (R-IA), noted that the “report has made a difference already by securing a much needed commitment from the Commissioner to make the FDA’s investigative unit live up to its significant responsibilities.” He added further that there was “no excuse for the fact that this division’s failures have gone unchecked for years, and having the FDA leadership focused on fixing what’s broken is the first, very important step needed.”
One nuance to the report is that OCI’s investigative load increased over the time frame studied. Although staffing and funding were also increased, the GAO did not comment on the ability for additional funds and staff to address the increased case load. It is unlikely however, that staffing and funding was enough since the OCI Director cited “limited resources” as one of the reasons why investigations were not continued and conducted.
The commitment Senator Grassley was referring to came from a letter written by FDA Commissioner Hamburg, who asserted that the agency is currently developing meaningful performance measures for OCI, in response to GAOs recommendations. Dr. Hamburg also noted that the agency is “implementing other significant efforts that address the issues in GAO’s report to enhance coordination, communication and strategic alignment of public health priorities between OCI and other Agency components.” She also indicated that a new committee was formed in August 2009 with members from various health agencies (e.g. CMS, HHS, etc.) to address regulatory priorities and activities.
With regards to the issues found in GAO’s report, Dr. Hamburg asserted that OCI is conducting outreach to the Centers and District Offices to better educate them about OCI’s role and responsibilities. She also addressed the fact that FDA is now developing criteria to include in its revised policies for consideration in selection of misdemeanor prosecution cases to hold “responsible corporate officials accountable.”
Recommendations
GAO concluded its report with the following three recommendations:
· To ensure OCI's compliance with investigative policies the Secretary of Health and Human Services (HHS) should instruct the Commissioner of FDA to have regular assessments of OCI's field offices conducted in accordance with its existing policy.
· To ensure OIA's compliance with investigative policies, the Secretary of HHS should instruct the Commissioner of FDA to establish a review procedure for the assessment of OIA's compliance with its investigative policies.
· To assess whether OCI's criminal investigative program is achieving its desired results, the Secretary of HHS should instruct the Commissioner of FDA to establish performance measures and assess program results against them.
Conclusion
While it seems clear that FDA has already begun implementing such changes and addressing the concerns of GAO, paying attention to the problems the OCI Director spoke of are equally important.
Prosecuting company officials and increasing the use of disbarment or disqualification can have a chilling and negative effect on developing new and innovative technologies and treatments.
Prosecutions for headlines should be avoided when OCI specifically noted that a problem with these investigations is that as the number of cases increases, the number of resources are limited (staff and funding). As a result, before any extreme measures are implemented, FDA should consider what increasing more resources to OCI would do to ensure better compliance with GAOs recommendations and which of those recommendations will actually keep us safer.