Washington, D.C., partner Jesse Witten wrote an article for Pharmaceutical Compliance Monitor titled, “Pharmaceutical Industry Executives Face Enforcement Risks Under the Responsible Corporate Officer Doctrine.”

Jesse discusses the recent decision of the D.C. Circuit in Friedman v. Sebelius, which demonstrates the enforcement risk to pharmaceutical and medical device industry executives under the “responsible corporate officer” (RCO) doctrine.  Under the RCO doctrine, officers, managers and in-house counsel employed by life sciences companies could face misdemeanor criminal liability and exclusion from Medicare and other federal health programs, even if they were not personally involved in wrongdoing. 

Jesse examines the origin and development of RCO, including interest expressed by the FDA and OIG in bringing misdemeanor prosecutions and exclusion actions under the doctrine. He notes both the Supreme Court and D.C. Circuit have issued opinions supporting the government’s enforcement theories.

“Executives can reduce their enforcement risks by ensuring that their organizations have effective compliance programs,” he said.

Click here to read the entire article.



Source: Pharmaceutical Compliance Monitor