U.S. officials have decided to step up their enforcement of a doctrine, dating back to the 1930s, that may put some drug company executives at risk.
In 1939, Congress authorized—as part of the Food, Drug and Cosmetic Act—the Responsible Corporate Officer doctrine. The doctrine held executives personally responsible for corporate violations to food and drug laws, allowing them to be criminally charged. The doctrine is particularly threatening to the health care industry.
Michael W. Peregrine, a partner at McDermott Will & Emery, told the Wall Street Journal yesterday that the doctrine is merely a way for prosecutors to work around the need to prove criminal intent. “It puts the pistol to the head of the very senior executives,” he added.
The government contends, however, that it seeks out cases where the executive was truly responsible for wrongdoing.
Read more about the government’s decision to step up enforcement on this doctrine.