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    744171

    Factors limiting the development of new contraceptives.

    Bennett JP

    Journal of Reproduction and Fertility. April 1974; 37(2):487-498.

    The rapid decline in the introduction of new drugs in the U.S. can be attributed to the Kefauver-Harris Amendment to the Food and Drug Act of 1962 under which the Food and Drug Administration gets its authority. The regulatory requirements for contraceptive development have greatly curtailed research by pharmaceutical companies in this area. Such aspects as the patent life-span of 17 years when compared to the amount of overall development time to provide the necessary data for the regulatory agencies (for chemical contraceptives about 10 years) reduces the patent life to a point where for industry the commercial return for high research investment is extremely poor. Regulations specifying the kinds of animals used in testing or oral contraceptive (OCs) or the dose levels used in such species have questionable relevance to the human experience. Decisions by the regulatory agencies before marketing which are without appeal, such as the case of chlormadinone acetate, certainly affect the U.S. drug industry. Recent contraceptive development has occurred outside of the U.S. Adverse publicity by lay press increasing fears about OCs has also led to cutbacks in the research by pharmaceutical houses. The introduction of the Contraceptive Development Branch by the United National Institue of Child Health and Human Development in 1969 was a big step forward in directing research towards new approaches to contraception. However, industry has been slow to involve itself in this program because of the restrictive patent laws of the National Institutes of Health. The Expanded Program of the World Health Organization in support of training and of research in new contraceptives is anxious to enlist the support of the pharmaceutical idustry and will operate under more enlightened patent rules. The total estimated funds required to support research in the reproductive field is $500-$600 million over 5 years. It is suggested that industry will become involved again in contraceptive research if government will share the risk of contraceptive development. Our incomplete knowledge of the forms in which contraceptive steroids act at levels in man represent a major obstacle to better steroidal contraceptive development.
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