This series of two articles will try to delineate the forces that are propelling the pharmaceutical industry into a major new phase of its evolution.

In the period 1946-1965, the leading drug companies were the primary determinants of the prescription practices of physicians. They enjoyed the initiative; they could, therefore, in large measure, control their own destinies. Since 1963, and with increased intensity since the beginning of 1966, the U. S. Food and Drug Administration has tried to displace the drug industry as the preponderant influence on prescribing. But its exercise of that role is predicated on faulty premises about how the safety and efficacy of a drug can be established and about how drugs might best be used in medical practice. The first article concludes that the FDA approach to drug regulation will be rejected by the medical profession.

The second article will describe the development of an alternative mode of drug control that will gradually displace that represented by the FDA and the implications of this development for the drug industry.