The US Food and Drug Administration (FDA) plans to increase criminal prosecutions of “responsible corporate officials,” agency Commissioner Margaret Hamburg has said.
Her comments came in a letter yesterday (March 4) to Republican Senator Charles Grassley, following a highly critical investigation of the agency’s oversight of its Office of Criminal Investigations (OCI), which reported this week that the FDA is not fulfilling its required assessment of the six OCI field offices.
“Of the 24 total office assessments that should have been completed by August 2009, only seven, or about 30%, were completed, and one office had not been assessed in over 10 years,” says the report of the investigation, conducted by the Government Accountability Office (GAO) at the request of Sen Grassley.
Moreover, while the OCI’s director meets weekly with a senior official in the Office of Regulatory Affairs (ORA) – the FDA office in which OCI is located – the OCI is not required to report specific information to ORA or other FDA senior-level offices as part of its formal reporting relationship, reports the GAO, which adds that, according to a senior ORA official, “OCI operates more autonomously than other offices.”
The OCI director also meets periodically with the manager of the agency’s Office of Internal Affairs (OIA), but again, there is no requirement to report specific information to the OCI or other FDA senior-level offices on its investigative activities or any process to routinely monitor the OIA’s compliance with its investigative policies.
The GAO investigators were told by the OIA manager that the number of investigations is such that he is generally involved in all of them, and can therefore review investigative documents before closing cases to assess compliance with investigative policies – his review alleviates the need for a process to monitor compliance with OIA’s investigative policies, he said. However, the investigators comment: “the potential effectiveness of this review is limited because it relies on the OIA manager, who is also responsible for supervising investigations.”
Among its recommendations for improvements, the GAO says the FDA should establish performance measures for the OCI and monitor it regularly, and set up a process to monitor the OIA for compliance with its investigative policies.
Commenting on the report’s findings in her letter to Sen Grassley yesterday, Commissioner Hamburg says the agency accepts its concerns and is already working on improvements, including an increase in “the appropriate use of misdemeanour prosecutions, a valuable enforcement tool, to hold responsible corporate officials accountable.”
It is also enhancing its debarment and disqualification procedures to prevent “non-compliant investigators from participating in new product development,” with faster, more transparent and consistent actions, and greater clarification as to how such actions can proceed concurrently with pending criminal investigations and prosecutions.
“The agency also will take steps to ensure that sponsors involved in the testing and development of new medical products have ready access to information about FDA’s debarment and disqualification actions. In addition, the FDA now is posting initiated and completed disqualification and debarment actions on-line,” she writes.
The OCI has been successful in its declared mission “to conduct and coordinate investigations of suspected criminal violations…and to collection evidence to support successful prosecutions,’ Dr Hamburg tells Sen Grassley. From its inception in 1992 until the end of FY2009, it obtained 4,392 convictions that resulted in the imposition of $9.89 billion in fines and restitution and forfeited assets worth over $1 billion, she notes.
Sen Grassley responded that the GAO report had “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. There’s 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,” he said.
– The OCI’s funding rose about 73% from $19 million in FY1999 to more than $41 million in FY2008, while staffing increased by about 40% during this period, from about 165 full-time equivalent employees to over 230, the GAO report also notes.
