Developing New Contraceptives Obstacles and Opportunities (1990) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-6
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The Committee on Contraceptive Development was appointed to explore organizational and policy issues affecting the development of such new contraceptive technologies. THE NEED FOR NEW CONTRACEPTIVES The committee found that important changes have taken place in contraceptive research and development over the past two decades.
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In the case of contraceptive products, however, the FDA assesses the potential impact of a contraceptive on healthy users, without sufficient recognition that the risks associated with a particular contraceptive drug or device may be outweighed by the advantages of the method for some users. The committee believes more weight should be given to variations among potential users that could influence their contraceptive practice.
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PRODUCTS LIABILITY LAW AFFECTING CONTRACEPTIVES The committee also recommends a change in public policy related to liability law that would contribute to the development of new contraceptives. Two aspects of recent products liability litigation and its impact are significant in the context of contraceptives: one is the unpredictable nature of litigation, which results in part from the absence of stable and uniform national products liability rules and in part from the often erratic character of the litigation system; the other is that, although manufacturers may introduce evidence of compliance with FDA regulations in a products liability lawsuit, this evidence is given no special status in most states.
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The committee believes that the products liability rules can be changed to remove most of their undue negative consequences for contraceptive development without increasing the health risks of contraceptive users. The committee has concluded that an aspect of a contraceptive drug or device that complies with the requirements of federal food and drug law should not be determined to be a defect or a breach of warranty under state law; that the manufacturer of that contraceptive product should not be held negligent for complying with FDAapproved designs or warnings; and therefore that the manufacturer of a specific contraceptive drug or device should not be the source of compensation to someone injured by that aspect of the particular contraceptive drug or device.
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But new birth control methods-even safer and more effective ones-will be of little benefit if they are not accessible, if they are not delivered properly with adequate screening and counseling, if they are not used, or if they are used incorrectly. Better education about human reproduction, sexuality, and contraception, shared responsibility, and more open communication between parmers about sex, health, and family planning are likely to increase motivation to use contraception and the ability of individuals to use methods effectively.
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