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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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