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References Adadevoh, Kwaku B. 1983 Needs for institutional support in developing countries. Pages 213-231 in E. Diczfalusy and A. Diczfalusy, eds., Research on the Regulation of Human Fertility, Volume 1. Copenhagen, Denmark: Scriptor. A.H. Robins Company 1980 1980 Annual Report. Richmond, Va.: A.H. Robins Company. 1938 The Dalkon Shield: Some Questions and Answers. Richmond, Va.: A.H. Robins Company. 1988 1988 Annual Report aM Form 10-K. Richmond, Va.: A.H. Robins Company. Alexander, Nancy J., and Deborah J. Anderson 1985 Immunologic approaches to fertility regulation. Pages 313-332 in Stephen L. Corson, Richard J. Derman7 and Louise B. Tyrer, eds., Fertility Control. Boston, Mass.: Little, Brown and Company. Alvarez, F., V. Brache, E. Fernandez, B. Guerrero, et al. 1988 New insights on the mode of action of intrauterine contraceptive devices in women. Fertility and Sterility 49:768-773. ALZA Corporation 1988a The OROS Technology: A Background Paper. ALLA Corporation, Palo Alto, Calif. 1988b Transdermal Technology: A Background Paper. ALZA Corporation, Palo Alto, Calif. American Fertility Society 1986 Ethical considerations of the new reproductive technologies. Fertility and Sterility 46:Suppl. 1. American Law Institute and National Conference of Commissioners on Uniform State Laws ~ or

156 REFERENCES 1965 Restatement of the Law, Second, Torts. St. Paul, Minn.: American Law Institute Publishers. Anand, Nitya, and V.P. Kamboj 1983 Role of the pharmaceutical industry of the developing countries in research on fertility regulation. Pages 975-986 in E. Diczfalusy and A. Diczfalusy, eds., Research on the Regulation of Human Fertility. Volume 2, Background Papers. Copenhagen, Denmark: Scriptor. Areen, Judith 1985 Cases and Materials on Family Low, 2nd ed. Mineola, N.Y.: The Foundation Press. Areen, Judith, Patricia King, Steven Goldberg, and Alexander Morgan Capron 1984 Low, Science and Medicine. Mineola, N.Y.: The Foundation Press. 1987 L - v, Science and Medicine: 19875upplement. Mineola' N.Y.: The Foundation Press. Atkinson, Linda E. 1979 Status of funding and costs of reproductive science research and contraceptive development. Pages 292-305 in Contraception: Science, Technology, and Application. Washington, D.C.: National Academy of Sciences. Atkinson, Linda E., Richard Lincoln, and Jacqueline Darroch Forrest 1985 Worldwide trends in funding for contraceptive research and evaluation. Family Planning Perspectives 17~5~(September/October): 196-207. 1986 The next contraceptive revolution. Family Planning Perspectives 18~1 )(January/ February): 19-26. Atkinson, Linda, S. Bruce Schearer, Oscar Harkavy, and Richard Lincoln 1980 Prospects for improved con~acepnon. Family Planning Perspectives 12~4~(July/ August): 17~1 92. Bardin, Wayne C. 1987 Public sector contraceptive development history, problems and prospects for He future. Technology in Society 9:289-305. Baulieu, Etienne-Emile 1985 RU486: An antiprogestin steroid win contraceptive ability in women. Pages 1-25 in Euenne-Emile Baulieu and Sheldon J. Segal, eds., The Antiprogestin Steroid RU486 and Human Fertility Control. New York: Plenum Press. Beck, L.R., and V.Z. Pope 1984 Long-acung injectable Norethistenone contraceptive system: Review of clinical studies. Research Frontiers in Fertility Regulation 3~2~:1-10. Berelson, Bernard 1969 National family planning programs: Where we stand. Pages 341-387 in SJ. Behrman, L. Corsa' and R. Freedman, eds., Fertility and Family Planning: A Worldview. Ann Arbor: University ofMichigallPress. 1978 Demographic Requirements of Fertility Control Technology: 15 Propositions. PIACT Paper, No. 1. Program for the Introduction and Adaptation of Contraceptive Technology (PIACT), Seattle, Washington. Berliner, V.R. 1974 U.S. Food and Drug Administration requirements for toxicity testing of contraceptive products. Acta Endocrinologica 75 (Suppl. 185~:4~265. Billingsley, Andrew 1968 Black Families in White America. Englewood, N.J.: Prentice-Hall. ~ ~ it, . .. .. .. . .

REFERENCES 157 Billy, John O.G. 1979 Accounting for the Availability of Family Planning Services in Counties of the U.S. Paper presented at the annual meeting of the Southern Regional Demographic Group. Birnbaum, Sheila L. 1980 Unmasking the test for design defect: From negligence [to warranty] to strict liability to negligence. Vanderbilt Law Review 33:593 649. Black Henry Campbell 1983 Black's Law Dictionary, abridged 5th ed. St. Paul, Minn.: West Publishing Co. Bleich, J. David 1981 Judaism and Healing. Hoboken, N.J.: Ktav Publishing House. Boulier, Bryan 1985 Evaluating Unmet Need for Contraception. Staff Working Paper, No. 679. The World Bank, Washington, D.C. Bracken, Michael B. 1985 Spermicidal contraceptives and poor reproductive outcomes: The epidemiologic evidence against an association. American Journal of Obstetrics and Gynecology 151:552-556. 1987 Vaginal spermicides and congenital disorders: Study reassessed, not retracted. Journal of the American Medical Association 257~21~:2919. Brown, Mark G., and Raynold A. Svenson 1988 Measuring R&D productivity. ResearchTechnologyManagement31~4~:11-15. Bruce, Judith 1987 User's perspectives on contraceptive technology and delivery systems: Highlighting some feminist issues. Technology in Society 9~3/4~:359-383. Buckles, R.G. 1979 Contraceptive Product Development in Public-Sector Programs. PIACT Paper No. 3. Program for the Introduction and Adaptation of Contraceptive Technology (PIACT), Seattle, Wash. Buday, Paul V. 1987 5100c~s and PMAs: Successfully meeting regulatory demands to commercialize medical devices. Food, Drug and Cosmetic Law Journal 42:559-566. Bulatao, Rodolfo A., and Ronald D. Lee, eds. 1983 Determinants of Fertility in Developing Countries. Committee on Population and Demography, National Research Council. New York: Academic Press. Bureau of National Affairs 1987 Product Safety and Liability Reporter 15~7~(February 13~:139. Cade, Toni 1970 The Pill: Genocide or liberation. Pages 162-169 in T. Cade, ea., The Black Woman: AnAn¢hology. New York: New American Library. Caldwell, John C., and Pat Caldwell 1988 Is the Asian family planning model suited to Africa? Studies in Family Planning 19(1):19-28. C1BA Pharmaceutical Company 1988 Background Information: The Transdermal Therapeutic System: Revolutionizing Drug Delivery. CIBA Pharmaceutical Company, Summit, N.J.

158 REFERENCES Clarke, R.N., F.R. Warren-Boulton, D.D. Smith, and M.J. Simon. 1988 Sources of the crisis in liability insurance: An economic analysis. Yale Journal of Regulation 5:367-395. Contraceptive Research and Development Program (CONRAD) 1988 Contraceptive Research and Development Program: CONRAD Investigators. Listing of Investigators and Projects, Eastem Virginia Medical School (March). Cook Rebecca, S. Bruce Schearer, and Jean Strand 1982 Contraceptives and Drug Regulation: AnIntemational Perspective. PLACT Paper No. 7. Program for the Introduction and Adaptation of Contraceptive Technology (PLACT), Seattle, Washington. Couric, Emily 1986 The A.H. Robins saga American Bar Association Journal 72(July 1~:56~60. Crooij, M.J., C.C.A. deNooyer, B.R. Rao, and G.T. Berends, et al. 1988 Termination of early pregnancy by the 3-Hydroxysteroid Dehydrogenase inhibitor Epostane. New England Journal of Medicine 319:813 817. Danzon, Patricia 1985 Medical Malpractice: Theory, Evidence and Public Policy. Cambridge, Mass.: Harvard University Press. 1 9 8 8 A _ Amy Insurance ror Contraceptives: Problems in Cost and Availability. Background paper prepared for the Committee on Contraceptive Development, National Research Council. Davis, Hugh J. 1970 The shield intrauterine device. American Journal of Obstetrics and Gynecology Degler, Carl 106~3~(February 1~:455-456. 1980 At Odds. New York: Oxford University Press. Department of Census and Statistics (Colombo) and Family Health International 1987 Sri Lanka Contraceptive Survey: An Innovative Approach to the Study of Traditional and Modern Contraceptive Practices. Colombo, Sri Lanka. Diczfalusy, E. 1985 Contraceptive futurology or 1984 in 1984. Contraception 31~1~(January):1-10. Diczfalusy, E., ed. 1977 Regulation ofHuman Fertility. Copenhagen, Denmark: Scriptor. Diczfalusy, E., and M. Bygdeman 1987 Fertility Regulation Today and Tomorrow. New York: Raven Press. Dienes, Thomas C. 1972 Law, Politics and Birth Control. Champaign-Urbana: University of Illinois Press. ~ ~ t -. - ~ ~ · ~ DiRaddo, J., and W.M. Wardell 1981 Research activity on systemic contraceptive drugs by the U.S. pharmaceutical industry. Contraception23~4~:345-365. Djerassi, Carl 1970 Birth control after 1984. Science 169:941-951. 1980 A new look at contraceptive testing. International Planned Parenthood Federation Bulletin 14~11(February): 1-2. 1981 The Politics of Contraception: Birth Control in the Year 2001, San Francisco, Calif.: W.H. Freeman and Company.

REFERENCES 1 59 1983 Future methods of fertility regulation in developing countries: How to make the impossible possible by December 31, l9g9. Pages 235-247 in E. Diczfalusy and A. Diczfalusy, eds., Research on the Regulation of Human Fertility. Copenhagen, Oer~mark: Scriptor. 1985 Searching for ideal contraceptives. Transaction 23~1 )(November/ December):41-43. 1987 Contraception in the year 2001. Pages 205-230 in Pieter A. van Keep, Kenneth Ellison Davis, and David de Wied, eds., Contraception in the Year 2001. Amsterdam, We Netherlands: Excerpta MedicalElsevier Science Publishers. 1989 The bitter pill. Science 245:356-361. Donaldson, Peter J. 1981a Evolution of the Korean family planning system. Pages 222-258 in Robert Repetto et al., eds., Economic Development, Population Policy, and Demographic Transition in the Republic of Korea. Cambridge, Mass.: Council on East Asian Studies, Harvard University Press. 1981b American Catholicism and the international family planning movement. Population Studies 42:367-363. Edelman, D.A. 1983 Development and Testing of Vaginal Contraceptives: Final Report. NIH contract no. NO1-HD-1-2800. Family Health International, Research Triangle Park, N.C. Eisman, Martin M., and William Wardell 1981 The decline in effective patent life of new drugs. Research Management 21(January): 18-21. Ekelman, Karen B., ed. 1988 New MedicalDevices: Invention, Development and Use. National Academy of Engineering and Institute of Medicine. Washington D.C.: National Academy Press. Fagley, Richard 1960 The Population Explosion and Christian Responsibility. New York: Oxford University Press. Family Health International 1988 1986-87 Report: Our 16th Anniversary. Family Health Intemational, Research Triangle Park, N.C. Fathalla, Mahrnoud F. 1989 New contraceptive methods and reproductive health. In Sheldon J. Segal, Amy 0. Tsui, and Susan M. Rogers, eds., Demographic and Programmatic Consequences of New Contraceptives: Proceedings of a Conference. Committee on Population. New York: Plenum Press Faundes, Anibal 1983 Contraceptive implants: State of the art and prospects for the future. Pages 489-505 in E. Diczfalusy and A. Diczfalusy, eds., Research on the Regulation of Human Fertility, Volume 2, Background Papers. Copenhagen, Denmark: Scriptor. Fawcett, James, ed. 1973 Psychological Perspectives on Population. New York: Basic Books.

1 60 REFERENCES Feldman, David 1968 Marital Relations, Birth Control, and Abortion in Jewish Law. New York: Schocken Books. Finkle, Jason L. 1971 Politics, development strategy and family planning programs in India and Pakistan. Journal of Comparative Administration 3:259-295. Food and Drug Administration (FDA) 1964 Report of the Public Board of Inquiry on Depo-Provera FDA Dkt. No. 78N- 0124 (October 17~:53-54,64. 1983 Proceedings of the Fertility and Maternal Health Drugs Advisory Committee. Transcript. Food and Drug Administration (December 15~. 1988 From Test Tube to Patient: New Drug Development in the United States. FDA Consumer Special Report. HHS Publication No. (FDA) 88-3168(January). Washington, D.C.: Department of Health and Human Services. Forrest, Jacqueline D. 1987 Has she or hasn't she? U.S. women's experience with contraception. Family Planning Perspectives 19~3~:133. Forrest, Jacqueline D., and Richard R. Fordyce 1988 U.S. women's contraceptive attitudes and practice: How have they changed in the 1980's? Family Planning Perspectives 20~3~:112-118. Forrest, Jacqueline D., and Stanley K. Henshaw 1983 What U.S. women think and do about contraception. Family Planning Perspectives 15~4~:157-166. Frazza, George S. 1987 Pages 297-298 in Statement Before the Committee on Energy and Commerce, Subcommittee on Commerce, Consumer Protection and Competitiveness. Free, Michael J., Richard Mahoney, and Gordon W. Perkin 1983 Transfer of Contraceptive Production Technology to Developing Counties. Pages 189-212 in International Symposium on Research on the Regulation of Human Fertility, Stockholm, Sweden (February). Freedman, R., and B. Berelson 1976 The record of family planning programmes. Studies in Family Planning 7(January): 1. Galen, Michele 1986 Birth-control options limited by litigation. 9~6~0ctober 20~:26-28. General Accounting Office The National Law Journal 1980 FDC Drug ApprovaW4 Lengthy Process that Delays the Availability of Important New Drugs. Report to the Subcommittee on Science, Research and Technology, by the Comptroller General of the United States, House Committee on Science and Technology. HRD-80-64 (May 28) Washington, D.C.: General Accounting Office. Gerson, Kathleen 1985 Hard Cho~ces: How Women Decide about Work, Career and Motherhood. Berkeley: University of California Press. Gillespie, Duff G., Harry E. Cross, John G. Crowley, and Scott R. Radloff 1989 Financing the delivery of contraceptives: The challenge of the next twenty years. In Sheldon J. Segal, Amy O. Tsui, and Susan M. Rogers, eds.,

REFERENCES 16 1 Demographic and Programmatic Consequences of New Contraceptives: Proceed~ngsof a Conference. Committee on population. New York: Plenum Press. Glendon, Mary Ann 1987 Abortion and Divorce in Western Law. Cambndge, Mass.: Harvard University Press. Goldberg, Stephanie 1986 Manufacturers take cover. American Bar Association Journal 72(July 1~:52-55. Goldenthal, E. I. 1968 Current Views on Safety Evaluation of Drugs. FDA Papers (May):13-18. Goldscheider, Calvin, and William Masher 1988 Religious affiliation and contraceptive usage: Changing American patterns, 1955-1982. Studies in Family Planning l9~1~(January-February):48-57. Gordon, Linda 1976 Woman'sBody, Woman' s Right: ASocialHistoryofBirth Control in America. New York: Grossman. Grabowski, Henry G., and John M. Vemon 1983 The Regulation of Pharmaceuticals: Balancing the Benefits and Risks. Washington, D.C.: American Enterprise Institute. Greep, Roy 0. 1979 Resources for research. Pages 255-264 in M. Potts and P. Bhwandiwala, eds., Birth Control: An International Assessment. Baltimore: University Park Press. Greep, Roy 0., and Marjorie A. Koblinsky 1977 Frontiers in Reproduction and Fertilidy Control: A Review of the Reproductive Sciences and Contraceptive Development. Cambridge,Mass.: M1T Press. Greep, Roy 0., Marjorie A. Koblinsky, and Frederick S. Jaffe 1976 Reproduction and Human Welfare: A Challenge to Research. Cambridge, Mass.: MlT Press. Griliches, Zvi, Ariel Pakes, and Bronwyn H. Hall 1987 The value of patents as indicators of inventive activity. Pages 97-124 in Panda Dasgupta and Paul Stoneman, eds., Economic Policy and Technological Performance. Cambridge, Mass.: Cambridge University Press. Grubb, G., H. B. Peterson, P.M. Layde, and G.L. Rubin 1985 Regret after decision to have tubal sterilization. Fertility and Sterility 30:345-350. Guillemin, R., R. Burgus, and W. Vole 1971 The hypothalamic hypophysiotropic thyrotropin-releasing factor. Vitamins and Hormones 29:1-39. Hagler, Louis, Faye Luscombe, and John Siegfried l9B7 A primer on postmarketing surveillance. Committee on Clinical Safety Surveillance of the Medical Section of the Pharmaceutical Manufacturers Association. Drug Information Journal 21:69-85. (Philadelphia, Penna.: Drug Information Association.) Hale, William 1987 Deputy Commissioner for Legal Affairs, North Carolina Department of Insurance. Personal communication with William Campbell (December 9~.

1 62 REFERENCES Halpem, Sue M. 1987 RU-486: The unpregnancy pill. Ms. (April):56-59. Haney, Robert 1974 Comstockery in America: Patterns of Censorship and Control. New York: DeCapo Press. Hansen, Ronald W. 1974 The pharmaceutical development process: Estimates of current development costs and times and the effects of regulatory changes. In Robert I. Chien, ea., IssuesinPharmaccuticalEconomics. Lexington,Mass.: Lexington Books. 1980 Pharmaceutical Development Cost by Therapeutic Categories. Graduate School of Management, University of Rochester. Working Paper No. GPB-80-6 (March). Harkavy, Oscar 1987 Funding contraceptive development. Technology in Society 9~3/4~:307-319. Harper, F., F. James, and O. Gray 1986 Torts, 2d ed. Vol. 3, Vol. 5. Boston: Little, Brown and Company. Harper, Michael J.K. 1983 Birth Control Technologies: Prospects by the Year 2000. Austin: University of Texas Press. Harper, Michael J.K., and Barbara Sanford 1980 Innovative approaches in contraceptive research. Pages 85-102 in Rochelle N. Shain and Carl J. Pauerstein, eds., Fertility Control: Biologic and Behavioral Aspects. Hagerstown, Md.: Harper & Row. Harrington, Scott E. 1988 Prices and profits in the liability insurance market. In Robert E. Litan and Clifford Winston, eds., Liability: Perspectives and Policy. Washington, D.C.: The Brookings Institution. Harrington, Scott, and Robert E. Litan 1987 Causes of the liability insurance crisis. Science 239:737-741. Hartmann, Betsy 1987 Reproductive Rights and Wrongs: The Global Politics of Population Control and Contraceptive Choice. New York: Harper & Row. Haseltine, Florence P., and Arthur A. Campbell 1986 lithe Impact of Fellowships Supported by the Andrew W. Mellon Foundation. Internal Report, National Institutes of Health (March 26~. Hatcher, Robert A., Felicia Guest, Felicia Stewart, Gary K. Stewart, James Trussel, and Erica Frank 1986 Contraceptive Technology 1986-1987. New York: Irving ton Publishers, Incorporated. Henry, A., W. Rinehart, and P.T. Piotrow 1980 Reversing Female Sterilization. Population Reports Series C (8~. Henshaw, Stanley K., and Jane Silverman 1988 lithe characteristics and prior contraceptive use of U.S. abortion patients. Family Planning Perspectives 20~4~(July/August):158-168. Henshaw, Stanley K., and Susheela Singh 1986 Sterilization regret among U.S. couples. Family Planning Perspeciive.s 18~5~:238-240.

REFERENCES ~ 63 Hensler, Deborah R., Mary E. Vaiana, James S. Kakalik, and Mark A. Peterson 1987 Trends in Tort Litigation: The Story Behind the Statistics. R-3583-1CJ. Santa Monica, Calif.: The RAND Corp. Herz, Barbara, and Anthony R. Measham 1987 The Safe Motherhood Initiative: Proposals for Action. Discussion Paper, no. 9. The World Bank, Washington, D.C. Himes, Norman 1936 MedicalHistoryofContraception. New York: Schocken Books. Hoberaft, John 1987 Does Family Planrung Save Children's Lives? Paper prepared for the Conference on Better Health for Women and Children Through Family Planning, Nairobi, Kenya, October 5~. Holmes, Lewis B. 1986 Vaginal sperrnicides and congenital disorders: The validity of a study. Journal of the American Medical Association 256~22~(December 12~:3096. 1987 Vaginal spermicides and congenital disorders: study reassessed, not retracted. Journal of the American Medical Association 257~21~(June 5~:2919. Hulka, Barbara S., and Nicholas Wright 1981 Contraceptive Evaluation: An Evaluation and Assessment of the State of the Science. National Institute of Child Health and Human Development. Washington, D.C.: U.S. Department of Health and Human Services. Institute for International Studies in Natural Family Planning QISNFP) 1988 Technical Progress Report: October 1, 1987-March 31, 1988. Georgetown University, Washington D.C. Institute of Medicine 1985 Vaccine Supply and Innovation. Washington, D.C.: National Academy Press. International Planned Parenthood Federation (IPPF) 1988 Femshield-A new barrier contraceptive for women. Medical Bulletin 22~3~(June):4. Issacs, Stephen L. 1981 Population Law and Policy. New York: Human Sciences Press. Isaacs, Stephen L., and Renee Holt 1987a Contraceptive technology and the law. Technology in Society 9~314~:339-358. 1987b Drug regulation, product liability, and the contraceptive crunch: Choices are dwindling. JournalofLegalMedicine8:533-553. Janowitz, Barbara, J.E. Higgins, D.L. Clopton, M.S. Nakumura, and M.L. Brown 1982 Access to post-partum sterilization in southeast Brazil. Medical Care 20~5~:526. Janowitz, Barbara, Thomas T. Kane, Jose Maria Arruda, Deborah Covington, and Leo Morris 1986 Side effects alla discontinuation of oral con~aceptive use in sou~em Brazil. Journal of Biosocial Science 18:261-271. JiCk Hershel, Alexander M. Walker, Kenneth J. Rodunan, Judith R. Hunter, Lewis B. Holmes, Richard N. Wadtins, Diane C. D'Ewart, Anne Danford, and Sue Madsen 1981 Vaginal spermicides and congenital disorders. Journal of the American Medical Association 245~13~(April 3~:1329.

1 64 REFERENCES Joffe, Carole 1986 The Regulation of Sexuality: Experiences of Family Planning Workers. Philadelphia, Penna.: Temple University Press. Johansson, Elof D.B. 1987 The future of contraceptive technology. Technology in Society 9:283-288. John D. and Catherine T. MacArthur Foundation 1987 Annual Report. Chicago, Ill.: MacArthur Foundation. Kahn, Henry S., and Carl W. Tyler, Jr. 1976 An association between the DaLicon Shield and complicated pregnancies among women hospitalized for intrauterine contraceptive device-related disorders. American Journal of Obstetrics and Gynecology 125~1~(May):83-86. Kaiser, Robert 1989 Vice President and General Counsel, London International U.S. Holdings, Inc. Personal communication (May 26~. Kaitin, Kenneth I., and A. Gene Trimble 1987 Implementation of the Drug Price Competition and Patent Term Restoration Act of 1984: A progress report. Journal of Clinical Research and Drug Development 1:263-275. Kaitin, Kenneth I., Barbara W. Richard, and Louis Lasagna 1987 Trends in drug development: The 1985-86 new drug approvals. Journal of Clinical Pharmacology 27~8~:542-548. Keeton, W. Page, ed. 1984 Prosser and Keaton on the Low of Torts. Fifth edition. St. Paul, Minn.: West Publishing Co. Kellner, Menachem Marc, ed. 1978 Contemporary Jewish Ethics. New York: Sanhedr~n Press. Kennedy, David 1970 Birth Control in America: The Career of Margaret Sanger. New Haven, Conn.: Yale University Press. Kertzer, Rabbi Moms N. 1978 What is a Jew? Fourth ed. New York: Collier Books. Kessler, Alexander 1983 Manpower and facilities for research In family planning. Pages 179-188 in E. Diczfalusy and A. Diczfalusy, eds., Research on the Regulation of Human Fertility, Volume 1. Copenhagen, Denmark: Saiptor. Kimble, William, and Robert O. Lesher 1979 Products Liability. St.Paul,Minn.: West Publishing Company. Kleinman, Ronald L., ed. 1988 1988 Directory of Hormonal Contraceptives. London, England: International Planned Parenthood Federation (IPPF) Intemanona1 Office. Klitsch, Michael 1988 The return of the IUD. February): 19-40. Family Planning Perspectives 20~11(January/ Knodel, John, Tony Bennett, and Suthon Pamyadilok 1983 Providing Pills Free: Does It Make a Difference? Thailand 's Experience With a Free Pill Policy. Research Reports, no. 8346. Ann Arbor, Mich.: Population Studies Center, University of Michigan.

REFERENCES 1 65 Laing, John E. 1978 Estimating the effects of contraceptive use on fertility: Techniques and findings from the 1974 Philippine National Acceptor Survey. Studies in Family Planning 9(6): 15~162. Lamanna, Mary Ann 1984 Social sciences and ethical issues: The policy implications of poll data on abortion. In S. Callahan and D. Callahan, eds., Abortion: Understanding Differences. New York: Plenum Press. Lane, M.E., R. Arceo, and A.J. Sobrero 1976 Successful use of the diaphragm and jelly by a young population: Report. Family Planning Perspectives 6~2~:61-86. Lapham, Robert T., and W. Parker Mauldin 1987 The effects of family planning on fertility: Research findings. Pages 647-680 in Robert J. Lapham and George B. Simmons, eds., Organizing for Effective Family Planning Programs. Washington, D.C.: National Academy Press. Lapham, Robert J., and George B. Simmons, eds. 1987 Organization for Effective Family Planning Programs. Working Group on Family Planning Effectiveness. Washington, D.C.: National Academy Press. Lasagna, Louis, and Lars Werko 1986 International differences in drug regulation philosophy. International Journal of Technology Assessment in Health Care 2:615-618. Lee, Nancy C., Herbert B. Peterson, and Susan Y. Chu 1989 Health effects of contraception. In A. Parnell, ea., Contraception and Reproduction: Health Consequencesfor Women and Children in the Developing World. Background Papers. Washington, D.C.: National Academy Press. Leiras Pharmaceuticals 1986 Norplant~ Contraceptive Implants. Turku, Finland: Leiras Medical Lettenmaier, Cheryl, Laurie Liskin, Cathleen A. Church, and John A. Harris 1988 Mother's lives matter: Maternal health in the community. Population Reports Series L (September) (7~. Levin, Richard C. 1986 A new look at the patent system. Area Papers and Proceedings 76~2~:199-202. 1988 Appropriability, R&D spending, and technological performance. American Economic Review 78~2~(May):424~28. Lewis, Daniel 1988 Executive Vice President, New Product Development, Stolle R&D Corp. Personal communication (March 4~. Lincoln, Richard, and Lisa Kaeser 1987 Whatever happened to the contraceptive revolution? International Family Planning Perspectives 13~4~(December):141-145. Liskin, Laurie, and Richard Blackburn 1987 Hormonal contraception: New long-acting methods. Population Reports (M arch-April): K-3: K-5 7 -K -87. Liskin, Laurie, and Ward Rinehart 1985 Mirulaparotomy and laparoscopy: Safe, effective, and widely used. Population Reports (May):C-9:C-125-C-167.

1 66 REFERENCES Littlewood, Thomas B. 1977 The Politics of Birth Control. Notre Dame, Ind. University of Notre Dame Press. Luker, Kristin 1984a Abortion and the meaning of life. In S. Callahan and D. Callahan, eds., Abortion: Understanding Differences. New York: Plenum Press. 1984b Abortion and the Politics of Motherhood. Berkeley: University of Califorrna Press. Lumbro so, Alex 1981 The introduction of new drugs. Pages 61-77 in Richard Blum, Andrew Herxheimer, Catherine Stenzl, and Jasper Woodcock, eds., Pharmaceuticals and Health Policy. New York: Holmes and Meter Publishers, Inc. Luulclcainen, T., J. Toivonen, and P. Lahteenmaki 1987 Medicated intrauterine devices. Pages 153-163 in E. Diczfalusy and M. Bygdeman, eds., Fertility Regulation Today and Tomorrow. New York: Raven Press. Lynch, Clay 1988 Senior Accountant, Family Health International. Personal communication (May 27~. Maine, D., and A. Rosenf~eld 1982 Maternal and child health benefits of family planning. Pages 1-12 in J.J. Sciarra, ea., Gynecology and Obstetrics. Hagerstown, Md.: Harper & Row. Malyk, B., and J.W. Kompare 1983 Contraceptive Efficacy Study of 2% Nonoxynol-9 gel with Diaphragm. June 17. Ortho Pharmaceutical, Raritan, N.J. Mansfield, Edwin 1986 Patents and innovation: An empirical study. Management Science 32:~2~173-181. Mastroianni, L., Jr., and C.H. Rosseau 1965 Influence of the intrauterine coil on ovum transport and sperm distribution in the monkey. American Journal of Obstetrics and Gynecology 93:416-420. Mattison, Nancy, A. Gene Trimble, and Louis Lasagna 1988 New drug development in the United States, 1963 through 1984. Clinical Pharmacology and Therapeutics 43 (March):29C~301. Mauldin, W. Parker, and Sheldon J. Segal 1986 Prevalence of Contraceptive Use in Developing Countries. New York: Rockefeller Foundation. McGarity, Thomas O. 1985 lithe role of regulatory analysis in regulatory decision making. Pages 107-364 in Administrative Conference of the United States: Recommendations and Reports. U.S. Government Printing Office Supt. Doc. no. 1986-153-115:50200. Washington, D.C.: Administrative Conference of the United States. Millaway, Elsie 1988 Population Council Accounting Office. Personal Communication (June 1~. Mohr, James C. 1978 Abortion in America: The Origins & Evolutions of National Policy 1800-1900. New York: Oxford University Press.

REFERENCES 1 67 Morrow, Margaret M., Michael J. Free, and Richard T. Mahoney 1988 The changing climate for the private sector. In Advancement of Indian Technologiesfor Reproductive and Other Health Applications. Report prepared for U.S. AID by the Program for the Introduction of Contraceptive Technology (PIACT). Munsey, R., and F. Samuel, Jr. 1984 Medical Device Regulation in Transition. Pages 35() 379 in Gary L. Yingling, ea., Seventy-Fifth Anniversary Corr~nemorative Volume of Food and Drug Law. Washington, D.C.: Food and Drug Law Institute. Murphy, Francis 1981 Catholic perspectives on population issues B. Population Bulletin 35~6~. Mutambirwa, Jane 1988 Users' Perspectives in Contraceptive Development. Background paper prepared for the Committee on Contraceptive Development, National Research Council and Institute of Medicine. National Academy of Engineering 1983 Competitive Status of U S. Pharmaceutical Industry. Pharmaceutical Panel, Committee on Technology and International Economic and Trade Issues. Washington, D.C.: National Academy Press. National Academy of Sciences 1987 Science and Technology Centers: Principles and Guidelines. Panel on Science and Technology Centers. Washington, D.C.: National Academy Press. National Research Council 1986 Population Growth and Economic Development: Policy Questions. Washington, D.C.: National Academy Press. 1989 Contraception and Reproduction: Health Consequences for Women and Children in the Developing World. Washington, D.C.: National Academy Press. National Research Council, Commission on Life Sciences 1979 Contraception: Science, Technology, and Application. Washington D.C.: National Academy of Sciences. 1983 RiskAssessment in the Federal Government: Managing the process. Committee on Institutional Means for Assessment of Risks to Public Health. Washington, D.C.: National Academy Press. National Science Foundation 1984 Assessment of the Industryl University Cooperative Research Projects Program (IUCR). (November) Volume. 1., Washington, D.C.: National Science Foundation. National Women's Health Network 1988 The Network News. (January/February). Nieman, L.K., T.M. Choate, G.P. Chrousos, D.L. Healy, M. Morin, D. Renquist, G.R. Merriam, I.M. Spitz, C.W. Bardin, E. Baulieu, and D.L. Loriaux. 1987 The progesterone antagonist RU486: A potential new contraceptive agent. New England Journal of Medicine 316:187-191. Noonan, John 1965 Contraception: A History of Its Treatment by the Catholic Theologians and Canonists. Cambridge, Mass.: Belknap Press of Harvard University Press.

1 68 REFERENCES Office of Technology Assessment 1981 World Population and Fertility Plying Technologies: The Next 20 Years. Washington, D.C.: Office of Technology Assessment. Ory, Howard W., Jacqueline D. Forrest, and Richard Lincoln 1983 Making Choices: Evaluating the Health Risks and Benefits of Birth Control Methods. New York: The Alan Guttmacher Institute. Owen, David G. 1980 Redwing the policies of strict products liability. Vanderbilt Law Review 33:68~715. Pasquale, Samuel A. 1980 Evaluation of new contraceptives: A study design. Pages 2-12 in Gerald I. Zatuchni, Minam H. Labbok, and John J. Sciarra, eds., Research Frontiers in Fertility Regulation. Hagerstown, Md.: Harper & Row. Pauerstein, Carl J. 1980 Some considerations concerning the design and interpretation of clinical trials. Pages 37~8 in Gerald I. Zatuchni, Miriam H. Labbak, and John J.Sciarra, eds., Research Frontiers in Fertility Regulation. Hagerstown, Md.: Harper & Row. Petchesky, Rosalind P. 1984 Abortion and Woman's Choice: The State, Sexuality and Reproductive Freedom. New York: Longman. Pettiti, Diana B. 1985 Statistical aspects of the evaluation of the safety and effectiveness of fertility control methods. Pages 313-332 in Stephen L. Carson, Richard J. Derman, and Louise B. Tyrer, eds., Fertility Control. Boston, Mass.: Little, Brown and Co. Pharmaceutical Manufacturers Association 1987 1987 AnnualReport. Washington,D.C.: PhannaceuticalManufacturers Association. Phillips, James F., Mian Bazle Hossain, A.A. Zahidul Hugue, and Jalaluddin Alcbar 1989 A case study of contraceptive introduction: Domiciliary depot-medroxy progesterone acetate services in rural Bangladesh. Id Sheldon J. Segal, Amy O. Tsui, and Susan M. Rogers, eds., Demographic and Programmatic Consequences ofNew Contraceptives: Proceedu~gsof a Conference. Committee on Population. New York: Plenum Press. Pines, Wayne L. 1981 A Primer on New Drug Development. HEW Publication No. (FDA) 81-3021. Washington, D.C.: U.S. Food and Drug A~ninis~ation. Population Council 1986 [1orplant@7 Worldwide No. 5 (August). New York: The Population Council. 1988 19~7AruuzalReport. New York: The Population Council. Population Crisis Committee 1985 Issues in con~acepEve development. PopulationBri~lag Sheets No. 15 (May). Potts, Malcolm 1988 Bird1 control methods in He United States. Family Planning Perspectives 20~6~(November/December):288-297. Potts, Malcolm, and Richard Lincoln 1988 Is Contraception at die End of the Line? Background paper prepared for the Committee on Contraceptive Development, National Research Council and Institute of Medicine.

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-170 REFERENCES Ryder, N.B. 1973 Contraceptive failure in the United States. Family Planning Perspectives 5~3~: 133-142. Schally, A.V., A. Arimura, Y. Baba, R.M. Nair, H. Matsuo, T.W. Redding, and L. Debeljuk 1971 Isolation and properties of the FSH and LH-releasing hormone. Biochemical and Biophysics Research Communications 16:392-399. Schirm, A.L., J. Trussell, J. Menken, and W.R. Grady 1982 Contraceptive failure in the United States: The impact of social, economic, and demographic factors. Family Pluming Perspectives 14~2~:68-73. Schwartz, Gary T. 1979 Foreword: Understanding products liability. California Law Review 67:435-496. Schwartz, Victor E. 1980 The Uniform Product Liability Act A brief overview. VanderbiltLaw Review 33:579-592. Scnmshaw, Susan, P. Engle, L. Ross, and K. Haynes 1987 Factors affecting breastfeed~ng among Mexican women in Los Angeles. American Journal of Public Health 77(4):467-470. Scrip 1987 U.S. market projections to 1991. Scrip 1180:18. Seaman, Barbara 1980a Female and Free: The Sex Life of the Contemporary Woman. New York: Random House (Fawcett Books). 1980b The Doctor's Case Against the Pill. Garden City, N.Y.: Doubleday. Segal, Sheldon J. 1987 The development of modern contraceptive technology. Technology in Society 9:277-282. 1989 Contraceptive innovations: Needs and opportunities. In Sheldon J. Segal, Amy O. Tsui, and Susan M. Rogers, eds., Demographic and Prograrnrnafic Consequences of New Contraceptives: Proceedings of a Conference. Committee on Population. New York: Plenum Press. Segal, Sheldon J., Amy O. Tsui, and Susan M. Rogers, eds. 1989 Demographic and Programmatic Consequences of New Contraceptives: Proceedings of a Conference. Committee on Population. New York: Plenum Press. Sham Rochelle N., Warren P. Miller, and Alan E. C. Holden 1984 The decision to terminate childbearing: Differences in preoperative ambivalence between tubal ligation women and vasectomy wives. Social Biology 31~1-2~: 4() 58. Shaw, Jane E., and John Urquhart 1981 Transdermal drug administration-A nuisance becomes an opportunity. British Medical Journal 283 (October 3~:875~76. 1988 Programmed, systemic drug delivery by He ~ansdermal route. Palo Alto, Cali£: AI~ACo~poration. Sherris, Jacqueline D. 1984 New developments in vaginal contraception. Population Reports (January- February) H-7:H-157-H-190.

REFERENCES ~ 71 Sivin, I., and H.J. Tatum 1981 Four years of experience with the TW-380A intrauterine contraceptive device. Fertility and Sterility 36:159-163. Smith, Steven D. 1987 The critics and die "crisis": A reassessment of current conceptions of tort law. Cornell Low Review 72:765-798. Stephen, Elizabeth H., and Apichat Chamratrithirong 1988 Contraceptive side effects among current users in Thailand. International Family Planning Perspectives 14~1~:9-14. Strandberg, Kjell 1985 Experiences from the WHO Collaboratoring Cerise for International Drug Monitoring. Drug Information Journal 19:385-390. Technology and the Regulation of Human Fertility (Special Issue) 1987 Technology in Society 9:3~. Temin, Peter 1980 Taking Your Medicine: Drug Regulation in the United States. Cambridge, Mass.: Harvard University Press. Thapa, Shyam, David Hamill, and Philip Lampe 1988 Continuation and Effectiveness of Program and Non-Program Methods of Family Planning in Rural Sri Lanka Paper presented at the United Nations Expert Group Meeting on Methodologies for Measuring Contraceptive Use Dynamics, New York (December 5-7~. Tietze, Christopher, and Stanley K. Henshaw 1986 Induced Abortion: A World Review, 6th ed. New York: Alan Guttmacher Institute. Troen, Philip, Gabriel Bialy, and Kevin Catt 1983 Contraceptive Development: An Evaluation and Assessment of the State of the Science. Washington, D.C.: U.S. Depar~nent of Health and Human Services, ldstitute for Child Health and Human Development. Trussell, James, and Anne R. Pebley 1984 The potential impact of changes in fertility on infant, child and maternal mortality. Studies in Family Planning 15~6~:267-280. Trussell, James, and Ka~ryn Kost 1987 Contraceptive failure in the United States: A critical review of the literature. Studies in Family Planning 18~5~:237-283. Ulmann, A., and C. Dubois 1986 Clinical dials with RU486. Editorial. New England Journal of Medicine (December 18~. United Nations 1983 Recent Levels and Trends in Contraceptive Use as Assessed in 1983. New York: United Nations. 1984 Recommendations for the Further Implementation of the World Population Plan of Action. UN Bloc. E/Conf. 76.5. International Conference on Population, Mexico City. 1987a World Contraceptive Use. Data chart prepared by the Population Division of the Department of International Economic and Social Affairs of the United Nations. United Nations, New York.

172 REFERENCES 1987b Consolidated List of Products Whose Consumption andlor Sale Have Been Banned, Withdrawn, Severely Restricted or Not Approved by Governments Second Issue, ST/ESA/192. New York: United Nations. Urang, Sally 1983 The pill and its marketing offspring. Chemical Business (July 25~:9-15. U.S. Agency for International Development (AID) 1989 Users Guide to the Office of Population. Agency for International Development, Washington, D.C. U.S. Congress 1983 FDA's Approval of tile Today Contraceptive Sponge. Hearing before a Subcommittee of the Committee on Government Operations, House of Representatives, 98th Congress, First Session (July 13~:130. 1987 H.R. 1 1 15 (100th Congress, First Session). U.S. Deparunent of Commerce 1979 Model Uniform Product Liability Act. Federal Register 44~0ctober 31~: 62717-62750. U.S. Department of Health and Human Services 1980 Vaginal contraceptive drug products for over-the-counter human use: Establishment of a monograph; proposed rulemaking. Federal Register 45~241~(December 12~:82014-82046. 1987 New drug, antibiotic, end biologic drug product regulations; fmalrule. Federal Register 52(March 19~:8798~847. U.S. Department of Justice 1986 Report of the Policy Working Group on the Causes, Extent and Policy Implications of the Current Crisis in Insurance Availability and Affordability. (February). Washington D.C.: U.S. Government Printing Office. 1987 An Update on the Liability Crisis and Tort Policy Working Group. (March). Washington D.C.: U.S. Govemment Printing Office. Van Keep, Pieter A., Kenneth Ellison Davis and David de Wied $ 1987 Contraception in the Year 2001. New York: Excerpta Medico Vessey, M., M. Lawless, and D. Yeates l9B2 Eff~cacyof different contraceptive methods. Lancer 1~8276~:841~42. Viel, Benjamin 1985 Induced Abortion in Latin America: Impact on Health. Symposium to honor Christopher Tietze, Berlin, Germany. Wahren, Carl 1983 The role of industry, agencies and governments in research on fertility regulation: Past experience and future prospects. Pages 301-349 in E. Diczfalusy and A. Diczfalusy, eds., Research on the Regulation of Human Fertility, Volume 1. Copenhagen, Denmark: Scriptor. Walsh Sharon W. 1988 Liability bill losing momentum. Washington Post (Sunday, April 10~. Wardell, William M. 1979 The history of drug discovery development and regulation. In Robert I. Chien, ea., Issues in Pharmaceutical Economics. Lexington, Mass.: D.C. Heads and Company.

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Developing New Contraceptives: Obstacles and Opportunities Get This Book
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There are numerous reasons to hasten the introduction of new and improved contraceptives—from health concerns about the pill to the continuing medical liability crisis. Yet, U.S. organizations are far from taking a leadership position in funding, researching, and introducing new contraceptives—in fact, the United States lags behind Europe and even some developing countries in this field. Why is research and development of contraceptives stagnating? What must the nation do to energize this critical arena?

This book presents an overall examination of contraceptive development in the United States—covering research, funding, regulation, product liability, and the effect of public opinion. The distinguished authoring committee presents a blueprint for substantial change, with specific policy recommendations that promise to gain the attention of specialists, the media, and the American public.

The highly readable and well-organized volume will quickly become basic reading for legislators, government agencies, the pharmaceutical industry, private organizations, legal professionals, and researchers—everyone concerned about family planning, reproductive health, and the impact of the liability and regulatory systems on scientific innovations.

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