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Capitol Health Call
April 14, 2010

Criminal Investigations

JAMA. 2010;303(14):1358. doi:10.1001/jama.2010.373

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg, MD, vowed that her agency is committed to improving the oversight and effectiveness of its Office of Criminal Investigations (OCI).

Hamburg's vow came in a March 4 letter to Sen Chuck Grassley (R, Iowa), who had requested a review in 2009 by the Government Accountability Office (GAO) into allegations of lax standards and poor responsibility in the FDA's criminal division. The GAO report (http://www.gao.gov/new.items/d10221.pdf) found the FDA's oversight of its OCI was limited, noting that 24 assessments of field offices, intended to ensure compliance with investigative policy, should have been completed by August 2009, but only 7 were finished. One office had not been assessed in more than 10 years. The OCI investigates a wide variety of criminal activities outside of the FDA, including the manufacture and sale of counterfeit drugs and illegal marketing of drugs.