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DEVELOPING _ . CONTRACEPTIVES Obstacles and Opportunities Luigi Mastroianni, Jr., Peter J. Donaldson, and Thomas T. Karate, editors Committee on Contraceptive Development Committee on Population Commission on Behavioral and Social Sciences and Education National Research Council and Division of International Health Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. 1990

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NATIONAL ACADEMY PRESS 2101 Constitution Avenue, NW Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distin- guished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Frank Press is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its ad- ministration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Robert M. White is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. Ibe Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Samuel O. Thier is president of the Institute of Medicine The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Prank Press and Dr. Robert M. White are chairman and vice chainnan, respectively, of the National Research Council. Library of Congress Cataloging-in-Publication Data Developing new contraceptives: obstacles and opportunities / Luigi Mastroianni, Jr., Peter J. Donaldson, and Thomas T. Kane, editors; Committee on Contraceptive Development ... [et. al.]. p. cm. Includes bibliographical references. ISBN 0-3()904147-3 1. Contraceptives Research United States. 2. Contraceptive dIugs~esearch- United States. L Mastroianni, Luigi. II. Donaldson,PeterJ. m. Kane,ThomasT., 1951-l RC137.D48 1990 613.9'4 dc20 Copynght ~ 1990 by the National Academy of Sciences Printed in the United States of America 89-13654 CIP

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Committee on Contraceptive Development LUIGI MASTROIANNI, JR. (Chair), Deparanent of Obstetrics and Gynecology, University of Pennsylvania WILLIAM A. CAMPBELL, Institute of Government, University of North Carolina RICHARD M. COOPER, Williams and Connolly, Washington, D.C. PATRICIA MUNCH DANZON, The Wharton School, University of Pennsylvania CARL DlERASSI, Department of Chemistry, Stanford University ANIBAL FAUNDES, Deparunent of Obstetrics and Gynecology, State University of Campinas, and the Population Council, Campinas, Brazil JOHN E. JEFFERIS, Pfizer, Inc., New York CHARLES B. KEELY, Department of Demography, Georgetown University PATRICIA A. KING, Georgetown University Law Center LOIS A. MONTIERO, Deparunent of Community Health, Brown University JANE M. MUTAMBIRWA, School of Medicine, University of Zimbabwe JUDY NORSIGIAN, Boston Women's Health Book Collective GORDON W. PERKIN, Program for Appropriate Technology in Health, Seattle, Wash. ALLAN G. ROSENFIELD, School of Public Health, Columbia University PETER TEMIN, Department of Economics, Massachusetts Institute of Technology BURTON A. WEISBROD, Department of Economics, University of Wisconsin PETER J. DONALDSON, Study Director THOMAS T. KANE, Research Associate DIANE L. GOLDMAN, Administrative Secretary

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Preface This report is the work of the Committee on Contraceptive Development, which is jointly staffed and administered by the National Research Council's Committee on Population and the Institute of Medicine's Division of Interna- tional Health. The report analyzes the process by which contraceptives are developed and approved for use in the United States and suggests ways to change that process to facilitate the development of safer, more effective, more conven- ient, and more acceptable new contraceptive methods. The study that produced this report is the most recent manifestation of a commitment by the National Research Council that began nearly 70 years ago with the establishment of its Committee on Research in Problems of Sex, for four decades a major force behind the development of scientific studies of human sexuality. Since then, other Research Council committees and, in this decade, the Institute of Medicine and the National Academy of Engineering have applied continuing analytic attention to a variety of issues related to human reproduction, population growth, and contraception. This report reviews the effects of factors that are widely believed to have slowed the development of new contraceptives, including the impact of the U.S. tort law system, the federal government's regulatory procedures, the organization of research and development activities, He distribution of scientific personnel and financial resources? as well as attitudes toward the control of reproduction. The Institute of Medicine and the Committee on Population were asked to undertake this study by the Andrew W. Mellon Foundation. The foundation, which has been a major supporter of reproductive biology and contraceptive development in the United States, had become concerned about the pace at which

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Vi PREFACE new products were being brought to the market and asked the committee to review the effects of organizational and policy issues on the contraceptive devel- opment process. The committee that undertook this study was composed of a diverse group of experts who represented a variety of backgrounds, perspectives, and disciplines. As with all committees of the National Research Council and of the Institute of Medicine, care was taken to ensure that the committee was balanced with respect to opinions and expertise related to contraceptive development. Particularly important in this regard was the fact that the scope of the committee's work and membership were reviewed by the Committee on Population as well as by the Commission on Behavioral and Social Sciences and Education and the Institute of Medicine, thus ensuring particularly careful scrutiny at the very earliest stages of the committee's work. During the course of the study, the Committee on Population reviewed the progress of the committee's work at each of its meetings and took responsibility for reviewing the final report. The Committee on Population also asked outside experts to review portions of the report. In addition, six other experts reviewed the report on behalf of the Commission on Behavioral and Social Sciences and Education and the Institute of Medicine. In short, since its inception, the work of the Committee on Contraceptive Development has been characterized by particu- larly high standards, broad representation, and careful scrutiny. In the course of its meetings, the committee heard from representatives of a variety of organizations involved in contraceptive development, including experts from federal government agencies, nonprofit organizations, the university re- search community, international organizations, and the pharmaceutical industry. The committee learned about contraceptive acceptability and use in the develop ing world from two of its members, one from sub-Saharan Africa and another from Latin America. The committee also commissioned several background papers on topics related to the development of new contraceptives. The Institute of Medicine and the Committee on Population appreciate the opportunity provided by the Andrew W. Mellon Foundation to investigate the process of contraceptive development and approval. Mellon Foundation support enabled the Committee on Contraceptive Development to undertake a detailed review of the development process and to carefully examine a variety of poten- tially important changes to the way contraceptives are developed and regulated. We are very grateful to the members of the Committee on Contraceptive Develop- ment, and especially to Luigi Mastroianni, Jr., the committee chair, for their efforts on this report ALBERT I. HERMALIN Chair, Committee on Population SAMUEL 0. THER President, Institute of Medicine

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Acknowledgments The committee is particularly grateful to the following people, who presented their views to the committee on the development of new contraceptives: Wayne Bardin of the Population Council, Jose Barzelatto of the World Health Organiza- tion, Leon Dash of the Washington Post, Gary Gereffi of Duke University, Florence Haseltine of the National Institute of Child Health and Human Develop- ment, Gary Hodgen of Eastern Virginia Medical College, Richard Lincoln of the Alan Guttmacher Institute, John McGuire of the Ortho Pharmaceutical Corpora- tion, Malcolm Potts of Family Health International, James Shelton of the Agency for International Development, Solomon Sobel and Bruce Stadel of the Food and Drug Administration, Bruce Vorhauer of Polymed Laboratories, and Koenraad Wiedhaup of Organon International. Their thoughtful presentations and their willingness to provide detailed answers to the committee's questions contributed greatly to the quality of this report. The committee also appreciates the work of Richard Lincoln, Malcolm Potts, and Cynthia Green, who prepared background papers for this report The committee especially appreciates the help of specialists who provided data and other information to the committee: Gabriel Bially, Arthur Campbell, Peggy Garner, Florence Hazeltine, Darlene Levenson, George Leverenz, and Ruth Ver- stieg of the National Institute of Child Health and Human Development; Linda Atkinson and Peter Carpenter of ALZA Corporation; Jacqueline Darroch Forrest, Susan Jew, and Richard Lincoln of the Alan Guttmacher Institute; Henry Ga- belnick of the Contraceptive Research and Development program; Laneta Dorflin- ger and James Shelton of the Agency for International Development; Sheldon Segal of the Rockefeller Foundation; J. Kellum Smith and Carolyn Makin son of . . V11

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~ ~ Vlll ACKNOWLEDGMENTS the Andrew W. Mellon Foundation; Wayne Bardin, Martha Brady, Oscar Har- kavy, and Elsie Millaway of the Population Council; San Balogh, Gary Grubb, Susan McIntyre, Robin Foldesy, and Roberto Rivera of Family Health Interna- tional; Philip Corfman, Susan Daugherty, Mark Ellengold, Raja Kammala, and Lillian Yin of the Food and Drug Administration; Henry Grabowski of Duke University; Richard Levin of Yale University; Ronald Hansen of the University of Rochester; Steven Wiggins of the University of Texas; John Wundrock and Pat Thome of Wisconsin Pharmacal; Lee Beck and Daniel Lewis of Stone Research and Development Corporation; Joan Dunlop of the International Women's Health Coalition; Louis Lasagna and Barbara Richard of the Center for Drug Develop meet; Roderick Mackenzie, Mary Kurtz, and Nancy Larson of GynoPharma; Peter Rowe of the World Health Organization; and Jacqueline Sherris and Patti Benson of the Program of Applied Technology in Health. Staff at the following organizations were also very helpful: Public Citizen; the National Right to Life Committee; the National Human Life Federation; the Kennedy Institute Center for Bioethics; the Pharmaceutical Manufacturers Asso- ciation; the Food, Drug, and Cosmetic Law Institute; and the Association for Vol- untary Surgical Contraception. The products liability attorneys, public relations officers, and directors of research and development and of regulatory affairs at companies involved in contraceptive research or marketing provided whatever in- formation their corporate policies allowed. We owe particular appreciation to Peter Donaldson, study director, and Tho- mas Kane, research associate, who helped organize the committee, provided necessary support throughout the study, and assisted with the drafting and coordi- nation of the report. We also thank Anna Boe, who provided a great deal of help with Chapters 7 and 8. We are grateful to Lisa Brecker, who aided the committee by collecting and analyzing data on various aspects of contraceptive develop meet. We also wish to thank Jill Gay, Jennifer Hess, Katherine Kost, Sahr Kpun- deh, and Susan Rogers, who assisted the committee in organizing its work. Eu- genia Grohman, associate director for reports of the Commission on Behavioral and Social Sciences and Education, critically reviewed the report. Christine McShane, CBASSE editor, edited and significantly improved the report; she also coordinated its review and publication. This report is truly a committee document. Members of the committee were committed and involved throughout the study, from early drafting through the final revisions. All of my colleagues on the committee made generous contribu- tions of time and expert knowledge; their insights and ideas were pivotal in the de- velopment of this report. LUIGI MASTROIANNI, JR. Chair, Committee on Contraceptive Development

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Contents Executive Summary..... Introduction ............ 2 The Need for New Contraceptives .... 3 The Current Status of Contraceptive Research . . 4 Values and Contraceptive Development............ 5 Organizational Structure of Contraceptive Development. 6 Funding for Contraceptive Development ................ 7 Regulation and Contraceptive Development .......... 7 . . . 30 . . . 41 89 8 Products Liability and Contraceptive Development 118 9 Contraceptive Development: Obstacles and Opportunities 147 References Legal Cases Related to Contraceptive Development. . . Glossary .... Index 1X 155 ........... 175 181

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