FDA pledges more criminal prosecutions

The FDA has this morning announced plans to increase criminal prosecutions of "responsible corporate officials," according agency Commissioner Margaret Hamburg.

Her comments come in a letter dated 4 March to Republican Senator Charles Grassley, following a highly critical investigation of the US Food and Drug Administration's (FDA) oversight of its Office of Criminal Investigations (OCI), which reported this week that the agency 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 percent, 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.

What's more, 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.

GAO investigators have reportedly been 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.

Compliance

His review alleviates the need for a process to monitor compliance with OIA's investigative policies, according to reports. 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, 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."

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."

He added that there is 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.

Matthew Buttell

Matt Buttell graduated from Bath Spa University in 2006. Since then he has written for several publications, before moving to the web. He now writes solely for the internet, continuing to cover key business issues while managing his own personal blog.

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