Federal regulation: philosophy and practice.

The philosophy of drug regulation as expressed by Congress has progressively embraced concepts of misbranding and adulteration, safety, efficacy, and, most recently, control of the investigational process. The intent of Congress has been implemented by a series of regulations intended to protect the public health and to assure that available drugs are safe and effective. This has resulted in more centralized, standardized, uniform government control, with a slowdown in the development and approval of new drugs, an increase in the cost of developing and marketing new drugs, and costly control procedures. It is time to ask whether the benefit of more centralized government control is being exceeded by its cost.