AN ANALYSIS OF DRUG REGULATORY AFFAIRS AND PHARMACEUTICAL RESEARCH AND DEVELOPMENT IN FRANCE, JAPAN AND THE UNITED STATES 1960-1980 (LAWS)

The use of drug therapy as a first line treatment for human disease expanded significantly in the mid 1940's. Since that time, new drugs have had a profound effect upon morbidity and mortality. Drug therapy today is perhaps the most cost efficient approach to the treatment of human disease. Therefore, the availability of new drugs in any specific country can be expected to have a significant impact upon the quality and cost of health care.; Research concerning the number of new drug introductions in the United States since 1940 revealed a marked rise up to 1959, followed by a precipitous fall through 1978. Wardell and others have attributed the fall in new drug introductions in the United States to drug regulations. Their comparative studies have demonstrated greater numbers on new drug introductions in Europe than the United States as well as shorter drug approval times.; This study examined the drug regulatory environment and pharmaceutical research and development in France, Japan and the United States from 1960-1980 in an effort to determine if comparative regulatory environments in addition to other factors (such as economies of scale) have caused certain types of drug development studies to be carried out in other key industrialized countries rather than in the United States. This movement of research activities outside the United States would explain the earlier registration of drugs abroad as well as providing insight into the operations of multinational pharmaceutical companies.; The case study method was utilized in this analysis, due to the proprietary nature of information associated with the movement of new drugs by multinationals during research and development.; The findings of this analysis include: (1) the emergence of a geocentric approach by multinationals toward pharmaceutical research and development and drug regulatory affairs (2) the movement of early preclinical studies to France and Japan from the United States, due in great measure to comparative regulatory environments, economies of scale and the multinational geocentric approach to research and development.