The 1990 report on contraceptive development by the National Research Council and Institute of Medicine (NRC/IOM 1990) paid detailed attention to the magnitude of regulatory factors and product liability as obstacles to new advances in the field. The study committee did not find the U.S. Food and Drug Administration (FDA) and its regulatory authority over contraceptives to be major obstacles, owing to important legislative and procedural changes that had occurred in the decade of the 1980s. In fact, the committee voiced support for the FDA's rigorous review and approval processes and described its own limited recommendations as ways to make the evaluation of product safety more meaningful and more specific to different user populations.

In contrast, the study committee concluded that the impact of product liability litigation, particularly on the cost and availability of liability insurance, was a very large contributor to the climate of disincentives for the development of contraceptive products. The weightiest aspects of litigation were its unpredictability and the fact that evidence of compliance with FDA regulations was granted no special status in liability lawsuits in most states. Thus, the committee recommended that the U.S. Congress enact a product liability statute that would, first, establish uniform standards for lawsuits involving contraceptives and, second, give manufacturers of an FDA-reviewed contraceptive product a defense based on FDA's acceptance of that product.

This chapter is an update of the work of that 1990 committee, meant to respond to the following questions: What of note has happened since 1990 in the areas of regulation and product liability related to contraceptive research and development; has the weight of those two variables on the field increased or

Front Matter (R1-R14)

Executive Summary (1-28)

1 Introduction (1-28)

2 The Need and Demand for New Contraceptive Methods (29-46)

3 Contraceptive Technology and the State of the Science: Current and Near-Future Methods (47-93)

4 Contraceptive Technology and the State of the Science: New Horizons (94-124)

5 The Market for New Contraceptives: Translating Unmet Need Into Market Demand (125-165)

6 The Translators: Sectoral Roles in Contraceptive Research and Development (166-235)

7 Issues of Law, Regulation, Information, and the Environment for Contraceptive Research and Development (236-340)

8 Recommendations (341-348)

Appendix A: Female Methods (349-380)

Appendix B: Male Methods (381-400)

Appendix C: Immunocontraceptive Approaches (401-429)

Appendix D: Barrier Methods and Mucosal Immunologic Approaches (430-473)

Appendix E: Agendas and Participants in Committee Workshops (474-489)

Appendix F: Committee Biographies (490-494)

Glossary (495-504)

Index (505-519)