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

Counseling Responsible Corporate Officers in a New Age of Government Food and Drug Enforcement
Christopher R. Hall, Gregory G. Schwab, Co-authors
The Champion

Christopher R. Hall, chair of the White Collar and Government Enforcement Practice Group and Gregory G. Schwab, associate in the Litigation Department, wrote this article in the September/October 2010 issue of The Champion, a publication by the National Association of Criminal Defense Lawyers (NACDL). The article discusses the dawn of new era in FDA compliance enforcement which began in March 2010 when the FDA gave notice to the pharmaceutical and medical device industries that it would use the responsible corporate officer (RCO) doctrine to enforce compliance with healthcare program fraud and abuse regulations.

The authors seek to guide practitioners in their assessment of whether their current compliance processes meet the governance obligations required by the RCO doctrine, and the possible collateral consequences that may follow if they do not, as well as offer best practices to avoid RCO liability and exclusion.