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9 Contraceptive Development: Obstacles and Opportunities
Pages 147-154

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From page 147...
... The increasing number of younger men and women in the United States who opt for surgical sterilization as a method of family planning, the high prevalence of abortions, and the very high rate of teenage pregnancy all point to the potential advantages that additional contraceptive methods might yield. More difficult to quantify but equally important reasons to develop new methods are the 147
From page 148...
... Although the methods that would function best in the different circumstances of each developing country vary widely, a broader spectrum of contraceptive methods would have beneficial effects on the fertility, health, and the well-being of people throughout the developing world. Limited contraceptive options have a greater negative impact in developing countries than in the United States because the health risks of pregnancy and childbirth are higher and the social benefits of contraceptive use can be much greater there than in the United States.
From page 149...
... Whatever the reasons, the nation offers far more support for research to alleviate specific illnesses than to prevent the burdens and trauma of unwanted pregnancy and its medical, psychological, and social consequences. Most sexually active people in the United States have some experience with contraceptive use and therefore some interest in methods that are safer, more convenient and, overall, more to their liking.
From page 150...
... Since basic research represents the underpinning of any future development, support for such research must keep pace with the rising cost of research and development in the United States. The product introduction phase of contraceptive development, which in the past has been substantially neglected, also merits greater attention and increased funding.
From page 151...
... The committee believes its recommendations would increase the effective use of contraception in the United States by enabling FDA to approve methods that would allow both users and providers of contraceptives to tailor specific methods more closely to the health conditions and family planning needs of each individual. LIABILITY The most frequently cited barrier to the greater availability and faster development of contraceptives is referred to as the liability crisis.
From page 152...
... Specifically, the committee recommends that Congress enact a products liability statute that establishes uniform standards for products liability lawsuits involving contraceptives and that gives manufacturers of an FDA-reviewed contraceptive product a defense based on FDA's acceptance of that product. The operation of the legal system in the United States makes it very difficult to forecast precisely the extent to which enactment of the proposed statute would change the perception of liability risk.
From page 153...
... companies and research institutions is important to the health and well-being of people in the United States and around the world. Encouragement and financial support for American research organizations to initiate, resume, or expand their contraceptive development efforts, as well as reevaluation of and changes in the FDA's mechanisms of assessment of the risks and benefits of contraceptives, and changes in products liability rules will speed the development and introduction of safer, more effective, and more acceptable new contraceptives for the twenty-first century.


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