Research activity on systemic contraceptive drugs by the U.S. pharmaceutical industry, 1963-1976.

The process of drug development and regulation in the U.S. is first reviewed, with special reference to contraceptives. We next summarize recent data on all pharmaceutical innovation in terms of new chemical entities (NCEs) developed by the U.S.-owned pharmaceutical industry from 1963-1976, and then examine the data on all contraceptive NCEs brought to the stage of clinical investigation by the U.S.-owned firms during that period. Of the 956 NCEs studied in man by 39 U.S.-owned firms, 20 NCEs from ten firms were identified as antifertility agents. Of these, 17 had INDs filed, three of the INDs reached NDA submission, and two of the submissions were approved. Since the mid-1960s there has been a decline in the number of antifertility NCEs taken into human testing anywhere in the world and in the number filed as INDs by U.S. firms. Apart from the approved NDAs, there were only two antifertility NCEs with active INDs at the end of 1976. There have been no marked differences between the oral systemic contraceptive NCEs marketed in the U.S. or Britain since 1963. However, taking both countries together, no true NCE has been introduced for systemic contraceptive use since 1968. Although this study shows declining activity in research on contraceptive NCEs by the U.S. industry, thus supporting to some extent Djerassi's prediction of a decade ago, it should be recognized that it does not include complete data on the research activities in this area by the U.S. government or other non-industrial organizations, or on research sponsored by any group on new contraceptive methods other than NCEs.