FDA promises a revamp of its criminal investigations unit

The Food and Drug Administration's unit for investigating counterfeit drugs, contaminated food and other criminal activities is suffering from a lack of oversight and operational review, according to the US government's General Accounting Office.

The Office for Criminal Investigations (OCI) needs to be more closely monitored by the FDA and have performance measures laid down to assess whether it is fulfilling its remit, says the GAO in a new report available here.

The OCI does not have to provide any information on the reasons for and nature of its investigations and how it is making use of funding, according to the report. In 2008 the office had a budget of $41m, employed 230 people and undertook 400 prosecutions.

The GAO notes that out of the 24 total office assessments that should have been completed on the OCI's six field offices by August 2009, "only seven, or about 30 per cent, were completed, and one office had not been assessed in over 10 years."

Meanwhile, another FDA unit which investigates cases of potential misconduct, criminal activity and other transgressions by FDA employees - the Office of Internal Affairs (OIA) - also needs to measures put in place to improve oversight and accountability, says the GAO.

The report was undertaken at the request of Senator Charles Grassley (Republican - Iowa), who said he was spurred into action after receiving "allegations about lax standards and poor accountability in the criminal division."

In response to the report, FDA Commissioner Margaret Hamburg sent a letter to Sen. Grassley indicating that the agency had already started work on "meaningful performance measures" for the OCI unit.

In August 2009, the agency formed a high-level committee to "enhance coordination and strategic alignment" between OCI and other FDA departments.

Recommendations from this exercise included improved procedures for information sharing, ways to better align criminal enforcement and regulatory activities, and an increase in the use of misdemeanour rather than felony prosecutions for "responsible corporate officials."

Hamburg also defends the OCI's record, noting that between its formation in 1992 and the end of 2009 it has obtained more nearly 4,400 convictions that resulted in the imposition of $9.89bn in fines.