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The Champion

September/October 2010 , Page 40 

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Counseling Responsible Corporate Officers in a New Age of Government Food and Drug Enforcement

By Christopher R. Hall; Gergory G. Schwab

The U.S. Food and Drug Administration (FDA) gave notice to the pharmaceutical and medical device industries in March 2010 that the agency would use the responsible corporate officer (RCO) doctrine to enforce compliance with healthcare program fraud and abuse regulations. By letter to Sen. Chuck Grassley dated March 4, 2010, FDA Commissioner Dr. Margaret Hamburg announced that her Office of Criminal Investigations (OCI) would use the doctrine in “appropriate” cases to “hold responsible corporate officials accountable” through misdemeanor prosecutions. Dr. Hamburg also advised Congress that the FDA would measure the efficacy of its enforcement effort in part by tracking the number of RCO prosecutions it brings. On a parallel track, the FDA has locked horns with several former pharmaceutical executives in a heated battle to establish its authority to exclude executives convicted under the RCO doctrine from participating in federal healthcare programs for care

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