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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
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