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Executive Summary Currently available contraceptive methods are not well suited to the religious, social, economic, or health circumstances of many Americans and, therefore, a wider array of safe and effective contraceptives is highly desirable. Important individual and social benefits are associated with lower rates of abortion and unwanted pregnancy, especially among teenagers, that new contraceptive meth- ods might help to bring about. The Committee on Contraceptive Development was appointed to explore organizational and policy issues affecting the develop- ment 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. All but one of the large U.S. pharmaceutical companies formerly conducting research on new contraceptives have withdrawn from the field. Partly as a result of this change, and partly as a consequence of changing patterns of support from the federal government, non- profit organizations and small firms have become more important for contracep- tive development. Although these organizations have experienced some initial difficulties, they are becoming better equipped to develop new products. Prog- ress, however, has been slow and it is not clear whether these groups will have the resources to discover, develop, and market fundamentally new methods success- fully. Although the rate at which new products will be developed cannot be forecast precisely, significant innovations in contraceptive technology are currently being 1

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2 DEVELOPl~G NEW CO=RACE~~ES studied in the United States and in other countries. Moreover, important improve- ments in contraception are already available to people in other countries; their appropriateness in the United States should be considered. New methods would help men and women meet the changing needs for contraception that they face during the different stages of their reproductive lives. An increase in the total number and type of contraceptive options available would help to ensure a better, healthier match of methods to users. Furthermore, societal needs change over time, and new methods could help societies address important social problems, such as the prevalence of sexually transmitted diseases. The significant gaps that currently exist in the range of available methods could be filled, in part, by developing new, safe, effective, and acceptable contraceptive methods for men, for breastfeeding women, for teenagers, for older women, and for those with a particular health condition or illness. Ensuring adequate and sustained financial and human resources is an impor- tant step in strengthening the ability of existing organizations and scientists to develop new contraceptives. Given the relatively small pool of scientists working in this field, the committee believes that special attention should be given to enhancing the training opportunities for young scientists interested in careers in reproduction and contraceptive development. FDA REGULATION OF CONTRACEPTIVE PRODUCTS The committee concludes that recent policy changes by the Food and Drug Administration (E7DA) have improved the review and regulation of contraceptive products. Questions remain, however, about the standards of safety and effective- ness applied to contraceptive products. For most drugs, the FDA reviews their risks compared with their benefits against a specific health condition or illness. 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. In addition, the committee concludes that the FDA should increase the weight it assigns to contraceptive effectiveness and convenience of use. Given the potentially serious health consequences of an unwanted pregnancy resulting from contraceptive failure, methods with fewer side effects are not necessarily safer if they have higher failure rates. The social and health risk of pregnancy will be important considerations for users and must be weighed in the calculation of the safety of methods. The committee does not propose reducing the safety requirements applicable to contraceptives. Instead, we propose adding new criteria to the evaluation of safety to make it more specific to different groups of users. The committee therefore proposes a change in policy with regard to FDA

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EXECUTIVE SUMMARY 3 practices that it believes would contribute to contraceptive development: the committee recommends that the FDA further revise its procedures for evaluating new contraceptive products by recognizing special safety advantages of new methods for identifiable groups not adequately served by already approved con- traceptive methods. FDA should be prepared to approve a contraceptive drug or device even if that drug or device presents a risk, if it can be shown that the new contraceptive also offers a safety advantage for an identifiable group of users when compared with that group's actual contraceptive practice, including nonuse. Such a contraceptive should be indicated only for a well-defined population that, in fact, is not adequately served by other contraceptives. The product's labeling should discuss all significant risks presented by the contraceptive. The effect of such changes might be that the FDA would view as adequate to support approval a benefit-risk ratio currently viewed as inadequate to support approval. Such an approval should be subject to conditions to help ensure that approval will enhance the health of users of the new contraceptive. In order for the FDA to make an adequate assessment that a contraceptive product is benefi- cial, it needs feedback about its effects on the health of users. The committee's recommendation that a comprehensive postmarketing surveillance system be established is a good way to ensure systematic and timely feedback. The committee does not consider an increase in the weight ascribed to contra- cepiive effectiveness and convenience to be a major change in the FDA regulation of contraceptives or a departure from the policy that the FDA applies with respect to other drugs. Rather, we view it as an effort to make the FDA's regulation of contraceptive drugs and devices more similar to its regulations of other drugs and devices. The committee strongly endorses the FDA's paramount concern for the safety of users of contraceptives, but we believe that concern can be most effectively exerted by changing the current standard applied by the FDA for approval of new contraceptives. The proposed change would still impose on contraceptive products a safety standard more demanding than that for other drugs and devices. 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. FDA approval, for example, does not entitle the manufacturer to a presumption that it acted with due care. Because of the length of time necessary for develop

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4 DEVELOPING NEW CO=RACE~IVES ment of a new contraceptive product and the costs of that development, manufac- turers, in considering whether to remain in the contraceptive field, are likely to give special attention to the prospects of extensive litigation. Without changes in the products liability rules and procedures, it appears likely that even fewer firms will allocate even fewer resources to contraceptive research and development. The committee believes that the products liability rules can be changed to remove most of their undue negative consequences for contraceptive develop- ment 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 FDA- approved designs or warnings; and therefore that the manufacturer of a specific contraceptive drug or device should not be the source of compensation to some- one injured by that aspect of the particular contraceptive drug or device. This defense would not be available if the contraceptive manufacturer withheld rele- vant information from the FDA in the approval process, or if information devel- oped after approval was not reviewed by the FDA for purposes of determining whether the contraceptive product, its marketing, or its labeling should be changed. The committee also notes that the important issue of providing adequate compen- sation to persons injured by defective products is part of a much broader question of the adequacy of existing private and social insurance mechanisms, and as such goes beyond the scope of this report. The committee therefore recommends that Congress enact a federal products liability statute that gives contraceptive manufacturers credit for FDA approval of contraceptive drugs and devices. Pharmaceuticals and medical devices are unique among products in the United States in the degree to which quality is regulated before they are released in the market. Given that a system of careful premarket- ing review exists, the necessity for liability as a quality control mechanism is greatly reduced. When the FDA has considered the relevant health and safety data on a contraceptive product, has approved the product, and has required warning and instructions to accompany the product, it is sound national policy to make this approval available to manufacturers as a limited defense and not to penalize them for something they could not have known at an earlier point. Because the statute would interact with postmarketing surveillance efforts, this recommendation would be more compelling if formal postmarketing surveillance studies were generally required. CONCLUSION There has been a tremendous growth in the use of modern contraceptives over the past three decades. Concern about side effects and the effectiveness of exist- ing methods and demand for safer, more effective, more convenient, and afford

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EXECUTIVE SUMMARY 5 able contraceptives have also grown. The importance of these issues both in the United States and in over countries is likely to increase in the decades to come. 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. But, unless steps are taken now to change public policy related to contraceptive development, contraceptive choice in the next century will not be appreciably different from what it is today.

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