Soon after receiving a greatly expanded mandate through the 1938 Federal Food, Drug, and Cosmetics Act the agency had to deal with the tremendous increase in production by regulated industries and with the extensive involvement by other government agencies in the wartime economy. This article describes how FDA met these challenges during the war, and further suggests that FDA's wartime experience has influenced the subsequent development of American administrative practice to a much greater extent than generally has been acknowledged. The staff works closely with FDA Centers during each significant recall with the goal of maintaining agency-wide consistency in policy and procedures. Business continues to be a prime target for government enforcement agencies. Corporations particularly are vulnerable because they are responsible for their employees' conduct in many instances, even where that conduct defied express direction.
Individuals operating in highly regulated industries are subject to the same threat.
A responsible relationship to a violation can suffice for a conviction, even without participation in the violative conduct. In this environment, prevention is the best defense, demanding a corporate culture that requires and rewards ethical and legal conduct, and that deters and punishes violative conduct. Internal compliance program are important to the achievement of these goals. Corporate compliance programs, if operated effectively, can produce tangible benefits in the event of a criminal investigation, and can help reduce certain civil liability. Moreover, in the near future, such programs may be necessary to comply with the duty of care imposed on corporate directors and managers.