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1 Introduction Most sexually active Americans have had some experience with contraception. But despite widespread contraceptive use, concern persists about the safety, effectiveness, cost, convenience, and acceptability of modern contraceptives. Outside the United States, particularly in developing countries where medical services appropriate for the diagnosis and treatment of contraceptive-related side effects are limited and where the health risks of pregnancy, labor, and delivery are much greater than in the United States, there is also a great deal of concern about people's ability to use existing contraceptive methods to meet their varying needs for safe, effective, and acceptable fertility control. The costs of unwanted pregnancies and childbirth for mothers and children, as well as for their families and the communities in which they live, can be very high. Questions about the social costs of different patterns of fertility and the desire on the part of sexually active men and women for better contraception have led to a renewal of interest in the development of new techniques for the control of fertility. The AIDS epidemic has also focused public attention on the potential impact of new contraceptive methods, but anxiety about AIDS is just the latest in a series of factors that have led specialists and concerned citizens alike to wonder why there have been so few advances in contraceptive technology over the past several decades. This report examines the obstacles to contraceptive development as well as the opportunities that current work in the field presents. The report addresses contraceptive development activities under way in the United States or supported by U.S. institutions. To consider the institutional 7

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8 DEVELOPING NEW CONTRACEPTIVES arrangements and policies that influence contraceptive development in other countries would require a separate study and much greater involvement of non- American experts. There are two exceptions to our focus on the United States. First, at several places in the report, we discuss the consequences that decisions related to contraceptive development made in the United States appear to have on people in developing countries. Second, we examine the role of the World Health Organization (WHO) and its Special Programmer of Research, Development, and Research Training in Human Reproduction in the development of new contracep- tives. WHO is one of the most important institutions involved in contraceptive development, and American scientists and organizations have Slaved a cn~cin1 role in WHO's program. Err L_ ._ ^L ~ ~.~ , ,_ __ W i; llvpe trials report Will oe read by the people who directly or indirectly shape contraceptive development policy in the United States. Three groups seem par- ticularly important in this regard. First are the legislators who set policy (for example through patent and tax laws), establish budgets, earmark funds, provide direction to regulatory agencies, and otherwise act to shape research priorities for the nation. A second group we hope to reach are the executives at organizations actively involved in efforts to develop new contraceptives. This group includes people working at pharmaceutical firms, those employed by the nonprofit groups engaged in contraceptive development, as well as the staff at the National Insti- tutes of Health, the Agency for International Development, and the private foun- dations that support research on new contraceptives. Third, we have tried to write the report in language and style that is easily comprehended by the public. It is a commonplace to claim that a particular problem or issue has broad public rele- vance, but that claim is more accurate when applied to contraceptive development than when used to describe most matters of science policy. Few other products touch so many neonle in ~ intimate anal Vat for rPar~hintr 'Amp ao ^~^A~;~^ do. We have worked to provide an empirical foundation for our analysis. The committee collected and reviewed data on the prospects for the introduction of new contraceptive methods; on public attitudes toward contraceptive develop- ment; on the costs and time needed for regulatory approval of new contraceptives; on the relationships among organizations involved in contraceptive research and development; on recent and proposed changes in regulatory requirements for contraceptives; on contraceptive products liability cases; and on the availability and costs of product liability insurance for contraceptive products. Because of the proprietary nature of information on research and development costs, new methods under development, and contraceptive products liability cases, it was impossible to obtain all of the information the committee would have liked. Individual companies were especially reluctant to divulge information on prod- ucts liability cases, contraceptive sales, or research and development costs. Nev- ertheless, we believe the report contains ample evidence to support the committee's analysis, conclusions, and recommendations. ~ ~ _ ~w _.A_ ~_-A~--A,5, ~v~ ~ ~vll~a~

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INTRODUCTION 9 ORGANIZATION The report, which is composed of nine chapters, describes the history, current status, and prospects of contraceptive development; analyzes the impact of a variety of institutional factors that shape the contraceptive development process; and makes recommendations on ways to accelerate the pace of contraceptive development in the United States. Following this introductory chapter, Chapter 2 provides an assessment of the advantages to be gained from new contraceptive methods. We argue that new male and female contraceptive methods would contribute to the well-being of men, women, and their families both in the United States and other industrialized countries and, with potentially far greater impact, among people in the less developed world. Chapter 3 reviews the specific contraceptive innovations that are being devel- oped, some of which could be available within the next 15 years. Chapter 4 provides a brief overview of Americans' attitudes toward fertility control and contraceptive development, noting their roots in values related to sex, childbear- ing, family life, and the role of women. These values have been much debated in recent years. To the extent that government officials, researchers, and executives of U.S. drug companies see new contraceptive products as likely sources of public controversy or disapproval, development may have been discouraged. The four chapters that follow address specific issues that the committee be- lieves are significant influences on the pace and direction of contraceptive re- search and development. Chapter 5 reviews the organization of contraceptive research and development and examines how existing organizational arrange- ments and recent changes in them influence development. Special attention is given to the links among the various types of organizations involved in He development process and the unique problems that small firms and nonprofit organizations have in trying to bring contraceptive products to the market. Fac- tors affecting the involvement of the pharmaceutical industry in the development and marketing of contraceptives are also discussed. One frequently overlooked factor that may influence the speed of progress in a scientific field is the pool of scientific personnel working in the area. Chapter 6 discusses both the human and financial resources available for contraceptive research, how these have changed over time, and how these changes may have affected the pace of development. Chapter 7 examines the role of the Food and Drug Administration (FDA) in the regulation of the development, testing, and use of contraceptives. The chapter reviews the efforts of the FDA to balance risks and benefits to individuals and society and examines recent changes in the regulation of contraceptive products. A number of specific issues related to the regulation of contraceptives in the United States and with relations between American and foreign regulatory agen- cies are also discussed.

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10 DEVELOPING NEW CO=~CE~~ES Chapter 8 analyzes tort liability for contraceptive products, which many people regard as the most important barrier to development efforts in the United States. We present data on the levels and Rends in liability actions for contraceptive products and review the history of cases in this area. This chapter also examines the relationship between liability and insurance, and the extent to which these affect the market for contraceptives and, hence, the incentives for research and development in this area. The final chapter summarizes the committee's review and makes recommen- dations for increasing the likelihood that new contraceptives will be developer In most cases, when faced with a choice between summarizing and presenting the specific pieces of evidence we drew on, we chose to provide the details. We hope this will enable readers to appreciate better the complex factors that shape the contraceptive development enterprise and to better understand our arguments and recommendations. We have also provided a brief executive summary for those who wish to have an overview of the report. The report concludes with a glossary to help readers who are unfamiliar with specific technical terms. There are no quick fixes to the problems caused by the limited range of contraceptive methods available to men and women in the United States and to millions of other men and women around the world. The regulation of human fertility is a complex process, and the development of new contraceptive products costs millions of dollars and takes years, not weeks or months, to complete. There are, however, opportunities for innovation that are not being pursued because of a series of identifiable barriers. This report analyzes those barriers, evaluates their impact on the way new contraceptives are being developed, and suggests ways of changing the organization of contraceptive development and the policies govern- ing work in the field that we believe would accelerate the pace of development.