ABSTRACT
Pharmaceutical marketing is influenced by a variety of external controls. The most obvious encroachment on free and unrestrained marketing of pharmaceuticals is congressional enactment of federal and state statutes, regulations, and ordinances. In 1940, the Food and Drug Administration (FDA) was transferred to the Federal Security Agency, the predecessor of the Department of Health, Education and Welfare, which subsequently became the Department of Health and Human Services. There are numerous antitrust statutes and trade regulations, however, that are applicable to all business entities engaged in or affecting interstate commerce. Additional federal laws affecting pharmaceutical marketing include environmental statutes and regulations. State anti-substitution laws represent an example of local governmental activity in the absence of federal preemption, and serve as yet another form of external control on the marketing of pharmaceuticals. In an effort to protect public health and welfare, individual companies and their trade associations have developed guidelines concerning numerous industry practices.
