1
Introduction

In late 1996, the Institute of Medicine's (IOM) Committee on Contraceptive Research and Development completed a major study of the state of contraceptive science, the need for new contraceptives, and factors helping or hindering response to that need.1 As part of its work, the committee reviewed case histories of experience with the development and introduction of new contraceptives, including a brief review of the contraceptive implant, Norplant®. The committee believed that the Norplant experience echoed critical elements in the history of several other contraceptives and that a detailed analysis of that experience would be particularly instructive. As the first real contraceptive innovation in over two decades and as a long-acting method requiring clinical intervention for application and removal, the method raised an especially wide range of issues that could offer valuable lessons about the barriers and problems to be addressed if other new technologies are to enter the contraceptive marketplace.

Thus, in April 1997, a subcommittee of that original study committee convened a workshop, Implant Contraceptives: An Illuminating Case Study in Current Dilemmas and Possibilities.2 Its objectives were to: (1) review newly available data on Norplant's efficacy, safety, and use; (2) extract lessons from presentations on diverse aspects of the method's development, introduction, use, and market experience; and, (3) explore approaches to developing and introducing new contraceptives based on learning from that experience.

The workshop consisted of 17 formal presentations; two organized dialogues, one on consumer perspectives, the other on new strategies for developing and introducing new contraceptive technologies; and extensive discussion among subcommittee members, presenters, and invited participants on the information presented and its implications. The subcommittee met in executive session after adjournment to analyze the workshop proceedings and develop a list of lessons and points for further consideration or action.



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OCR for page 1
1 Introduction In late 1996, the Institute of Medicine's (IOM) Committee on Contraceptive Research and Development completed a major study of the state of contraceptive science, the need for new contraceptives, and factors helping or hindering response to that need.1 As part of its work, the committee reviewed case histories of experience with the development and introduction of new contraceptives, including a brief review of the contraceptive implant, Norplant®. The committee believed that the Norplant experience echoed critical elements in the history of several other contraceptives and that a detailed analysis of that experience would be particularly instructive. As the first real contraceptive innovation in over two decades and as a long-acting method requiring clinical intervention for application and removal, the method raised an especially wide range of issues that could offer valuable lessons about the barriers and problems to be addressed if other new technologies are to enter the contraceptive marketplace. Thus, in April 1997, a subcommittee of that original study committee convened a workshop, Implant Contraceptives: An Illuminating Case Study in Current Dilemmas and Possibilities.2 Its objectives were to: (1) review newly available data on Norplant's efficacy, safety, and use; (2) extract lessons from presentations on diverse aspects of the method's development, introduction, use, and market experience; and, (3) explore approaches to developing and introducing new contraceptives based on learning from that experience. The workshop consisted of 17 formal presentations; two organized dialogues, one on consumer perspectives, the other on new strategies for developing and introducing new contraceptive technologies; and extensive discussion among subcommittee members, presenters, and invited participants on the information presented and its implications. The subcommittee met in executive session after adjournment to analyze the workshop proceedings and develop a list of lessons and points for further consideration or action.

OCR for page 1
The report is organized in the following manner: The first section reviews the major points in the workshop presentations and dialogues, concluding with a summation of the principal lessons they provided and the areas of action most urgently suggested for the future. It is followed by three appendixes and detailed endnotes. Appendix A contains abstracts of the 15 formal presentations in a common format. Appendix B presents background material on the technology and a chronology of its development and market experience. Appendix C provides the workshop agenda and list of participants. The endnotes consist of references made by presenters and other information deemed necessary to support and clarify the text.