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  • Title: Introducing new contraceptives.
    Author: Segal SJ, Coutinho E.
    Journal: Draper Fund Rep; 1986 Dec; (15):27-32. PubMed ID: 12341234.
    Abstract:
    At this time, private research efforts to discover new contraceptives are threatened. Drug companies, particularly in the US, have reduced their interest in contraceptive development due to concern over the rising cost of product liability insurance, the cost of lawsuits in defense of liability claims, and the fear of extremely high awards by juries in product liability cases. The current form of private-public collaboration, now threatened by the liability crisis, works under a few simple principles of agreement. Private industry agrees to supply its patented chemical compounds for assessment as contraceptive agents, to be willing to enter into negotiations with public sector organizations to develop the contraceptive drugs if initial tests warrant it, and to release compounds to another company if the patent-holder declines to proceed with contraceptive development. The public-sector program agrees to fund the studies, keep the industry informed, and maintain confidentiality. When the technology is discovered by the public sector and is of potential interest to private industry, the collaboration involves other issues. The public agency agrees to supply manufacturing know-how and all biological and clinical information, to license under applicable patents, and to permit cross reference to regulatory agency filings. Private industry agrees to use its best efforts to bring the product to market, to manufacture the product at reduced cost for public sector use, or to provide know-how for others to do so. It also agrees to assume product liability and to grant the public sector agency licenses to any patented improvement in its product. Contraceptive research both within and outside the US is feeling the effects of the US litigious atmosphere. Companies from abroad now wish to steer clear of contraceptive research, even though these companies would be prepared to meet the requirements of the Food and Drug Administration. Contraceptives, considered to be high risk targets for lawsuits, are receiving little of the research budgets of pharmaceutical companies. Opposition anti-abortion forces also has had an effect. When the Population Council received new drug approval for the Copper-T-200, it was the 1st time the FDA had issued approval to a noncommercial sponsor. This unprecedented event established a new phase in the cooperative efforts between industry and the nonprofit sector to develop contraceptive products. It showed that given adequate funding, nonprofit agencies can carry out full product development, including the initial regulatory agency clearances.
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