Tuesday, March 9, 2010

GAO: FDA Criminal Investigations Unit Lacks Oversight

As posted online in Securing Pharma, according to a report from the General Accounting Office (GAO) the U.S. Food and Drug Administration’s (FDA) unit responsible for investigating counterfeit drugs, contaminated food and other criminal activities lacks sufficient oversight and operational review.

The GAO report on the FDA was initiated based on a request from Senator Charles Grassley (R-Iowa).

The GAO found that the FDA’s Office for Criminal Investigations (OCI) needs to be more closely monitored by the FDA and have appropriate performance measures in place for proper assessment.

The OCI operates semi-autonomously within the FDA and is not mandated to provide any information on its investigations. According to the study, the 2008 the budget for the OCI was $41M. The OCI as a unit within the FDA employed 230 people and instigated approximately 400 prosecutions.

Securing Pharma reports:

· 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."
· 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.

Secure Pharma Chain endorses an enhanced oversight of the regulatory agencies and the continued growth of their enforcement tools to adequately protect vital supply chains and consumers.

To read the entire Securing Pharma story, visit: http://www.securingpharma.com/40/articles/399.php.

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