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Index A Abortion attitudes toward, 46, 47-49 contraceptive development and, 49-50, 53 contraceptive failure and, 23-24 prevalence of, 147 Africa, contraceptive use in, 21, 28 Agency for International Development (AID) contraception delivery, 103 contraception research, 59 contraceptive development funding, 56, 58, 65, 68, 80, 81, 88 programs funded by, 60, 61~2, 64, 66,75 AIDS (Acquired Immune Deficiency Syndrome), 7, 15, 18, 85 Alan Guttmacher Institute (AGI), 78-79, 80, 86 ALZA Corporation, 78, 120, 122, 139 American Fertilitr Society, 50 181 American Home Products CoIporation, 60 Animal studies appropriateness for testing contraceptive drugs, 100, 115-116 in drug development, 92 extrapolation to humans, 100, 11~116, 132, 145 FDA testing regulations, 95, 9~99, 106 male vaccine research, 34 Antiprogesterone, 39 Asia, contraceptive use in, 21 Association for Voluntary Surgical Contraception, 63 Atherosclerosis, 34 Augustine, Saint, 44 B Bangladesh, 26, 112 Baroldy v. Ortho Pharmaceutical Corp. (1988), 133

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1 82 INDEX Bamer methods, 25, 26 see also specif c methods Berelson, Bernard, 26 Berlex Foundation, 82 Berlex Laboratories, Inc., 120 Beta blocking agents, 36 Beyette v. Ortho Pharmaceutical Corp. (1987), 129 Biodegradable pellets, 32, 61 Birth Control Federation of America, 52 Blacks, 42 see also Minorities Breast cancer, 25 Breastfeeding, 26, 33, 6~61, 148 Brochu v. Ortho Pharmaceutical Corp. (1981), 132 Buck v. Bell (1927), 4~47 C Calufornia Supreme Court, 125 Canada, 84, 111 Cancer contraceptives as risk factor for, 95, 98,101 Depo-Provera end, 99 diaphragms and, 18 oral contraceptives and, 15, 17-18, 25 Captive insurance companies, 138, 139 Cardiovascular diseases, 17 see also Hypertension Casii Connutii Pius Xr), 44 Catholic church, 44 Center for Population Research (CPR, NICHD), 58, 70, 75 Centers for Disease Control, 127 Central Conference Of AmP~r~n ~ _ ~ ~ ~A ~ ~ Rabbis, 43 44 Cervical cancer, 18, 99 Cervical cap, 22 Cervical mucus, 17, 32 Chambers v. GO. Searle & Co. (1975), 131n Children, 24 Church of England, 44 Clinical Research International, 76 Clinical trials contraceptive effectiveness in, 102 phases of, 92 regulatory requirements, 94, 95, 96, 111-112, 113, 116, 15~151 side effects and safety in, 100 see also Research Coagulation, 117 Cobb v. Syntex Laboratories, Inc. (1984), 131n Collins v. Ortho Pharmaceutical Corp. (1986), 129 Committee on Research in Problems of Sex, 75 Common law, 47, 123,124, 125 Complications, 1~18, 24-25 ofIUDuse,15, 127 see also Side effects Comstock Act (1873),45 Condoms current use of, 14, 15 effectiveness of, 18, 22 female, 36 market for, 60 products liability law and, 122, 123, 134-135 regulation of, 106 107, 108 research on, 36 Conservative Rabbinical Assembly, 43-44 Continuation rates, 27 Contracap, Inc., 78 Contraceptive development American values and,41-54, 149 competition in, 68 defined, 79 effectiveness requirements, 101-106 funding levels, 80

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INDEX 183 women's attitudes toward, 51-53, 54 i] funding recommendations, 8~87, 88 .mportance of, 1-2, 23-27, 28-29, 147-148 liability and, 118-119, 135, 137-140, 145-146 liability recommendations, 142-143 need for, 1-2, 11-14, 147-148 obstacles to, 12-13, 53-54, 109, All, 149-150 organizations in, 71-74 regulation of, 9~93 regulatory recommendations, 11~116 research status, 30~0, 112 safety requirements, 95-101 training recommendations, 86, 88 Contraceptive devices, regulation of, 106 107 Contraceptive implants, 27,31, 37, 38, 64 see also NOR PLANT Contraceptive Research and Development Program (CONRAD), 56, 60,61, 64, 66, 82 Contraceptives abortion and, 49-50 benefits of, 12-13, 24,151 current use of, 14-21, 152 delivery of, 27-28 effectiveness of, 14, 15-19, 22-23, 25,27, 33,35, 36,37, 38,127, 147-148, 152 effectiveness of, regulations on, 2, 3, 101-106, 114, 115, 11~117 law and, 45~8 prices of, 112, 113 regulation outside United States, 110-114 religion and, 43~5 risks of, 3, 96, 102-105,110, 11~117 Contraceptive sponge, 18-19 current use of, 15,20 effectiveness of, 18, 22 Today brand,31, 60, 63, 66, 78, 94, 104 Contraceptive steroids new delivery methods, 31-34, 35 regulatory requirements, 100, 109, 111-112, 117 toxicological testing of, 9~97, 116 Contraceptive vaccines, 33-34, 39~0. 89,146 Contraindications for available contraceptives, 117, 130, 148 Copper IUDs, 35, 64 Copper-7, 122, 128-129, 130, 137-138 Copper T200, 113 Copper T380A (ParaGard), 17,31, 61, 122 Cygnus Research Corporation, 78 D Dalkon Shield, 108, 120, 121-122, 12~128 Davis, Hugh J., 127 Death, see Mortality Demulen 21 pill, 131n Denmark, 84 Depo-Provera, 31, 117 current use of, 37-38 FDA rejection of, 94, 97-100, 104 Desogestrel, 35 Diaphragm, 18 current use of, 15 disposable, 36 effectiveness of, 18, 22 products liability law and, 122-123, 133 regulation of, 93,106-107, 108 risks of, 52

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1 84 INDEX Drug companies, see Pharmaceutical industry Drug Price Competition and Patent Term Restoration Act (1984), 94,106,116 Drugs current FDA requirements, 98 development of, 9~93 generic, 94, 106 liability law and, 126 regulation of, 89,95 Drugs, contraceptive, see Contraceptive steroids Duncan v. Syntex Laboratories, Inc. (1977), 131n E Eastern Virginia Medical School, 56, 60, 61~2 Ectopic pregnancy, 15, 17, 37, 12~129 Egypt, contraceptive use in, 21 Eiser v. Feldman (1986), 131n Endocon Corporation, 61, 78 Endometrium, 17, 50 English common law, 47 Enovid pill, 13 In, 132n Environmental Protection Agency, 81 Epididymis, 34 Estrogens, 16, 33, 34, 132 assay for, 35 Eugenics, 42, 46 Europe contraceptive use in, 21, 37 regulation in, 111-112 European Economic Community (EEC), 111, 112 F Failure rates, see Contraceptives, effectiveness of Fallopian tubes, 16, 3~37, 39 occlusion plugs, 107-108 Family Health International (EiEII), 56, 60, 66, 81 funding by, 62, 63, 69, 77 funding of, 76, 82 and liability insurance, 137 Family planning services, 23, 26, 28 Federal Council of Churches, 44 Federal Food, Drug and Cosmetic Act (~;FDCA) (1982 & Supp. III 1985), 93-94, 105 effectiveness requirements, 101 Medical Device Amendments (1976), 94, 107, 108, 127n safety requirements, 95-96, 99, 102, 127n Female methods research status, 31-34 sterilization, 14, 16, 2~21, 36, 39 Feminism, 52, 53 Fertility, new contraceptives and, 27 Fertilization, 50 Filshie clip, 39 Follicle-stimulating hormone (FSH), 34 Follicular growth, 35 Food and Drug Administration Q;DA), 35, 56 Advisory Committee on Fertility and Maternal Health Drugs, 38, 93, 97, 134 Advisory Review Panel on OTC Contraceptives and Other Vaginal Drug Products, 134 approval of contraceptives, 34, 36, 38, 63~4, 90, 94, 109, 126, 152 approval and products liability, 3=, 119, 129-130, 141, 142-146 Center for Devices and Radiological Health, 106 107 and Dalkon Shield, 127-128

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INDEX 1 85 Medical Dewce Center, 36 New Drug Applications, 31, 64 regulation of drugs, 95-106 Hayes, Arthur Hull, Jr., 104, 117 regulation of medical devices, Health 106 109 benefits ofcon~aceptives, 12, 24, 151 H regulatory requirements, 2-3, 89-90,92-93, 111-112, 11~117, 15~151 safety, attitude toward, 12, 104, 117, 119 safety requirements, 3, 95-101, 122 warnings, 131 Ford Foundation, 65,76, 80, 82, 84, 86 Fourteenth Amendment, 48 Fraudulent misrepresentation, 124, 143 Funding, 58, 75-77, 150 competition for, 68 foundation, 65, 82~3 government, 56, 64~5, 78-81 nonprofit organization, 56, 62~3 outside United States, 83~4, 86 pharmaceutical industry, 57, 77-78 recommendations on, 8~87, 88 research training, 84-86 G General Accounting Office (GAO), 109, 111 Generic drugs, 94, 106 Georgetown University, 61~2 Georgia, 134 Gestodene,35 Goodson v. Searle Laboratories (1978), 131n Gossypol, 34-35 Greenman v. Tuba Power Products, Inc. (1963), 125 Griswold v. Connecticut (1965), 45~6 Gynex, Inc., 61, 78 GynoPharma, Inc., 36, 61, 120,122 and regulation, 2, lW,117, 151 risks, 1~18, 25, 114-116, 147-148 Hewlett, William and Flora, Foundation, 82 Hispanics, 26 see also Minorities Hoechst-Roussel Pharmaceuticals, Inc., 59 Holmes, Oliver Wendell, Jr., 46 lIormone-releasing IUDs, 35 Human chorionic gonadotropin (hCG), 33, 34 Hypertension, 15, 117, 151 I Implantation, embryo, 17,50 Implants, contraceptive, 27, 31, 37, 38,64 see also NORPLANT~ India and contraceptive development, 55, 69,112-113 contraceptive use in, 21 Indiana, 46 Inhibin, 34, 66 Injectable contraceptives, 26, 31, 33-34,37-38 microsphere, 32, 6(}61, 66 see also Depo-Pxovera Institute olMedicine, 146 Institutional review board (IRB), 94, 108 Insurance, see Liability insurance Interagency Council on Population Research (ICPR), 78,82, 83 Interception, 50

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186 INDEX International Committee for Contraception Research, 63 International Planned Parenthood Federation, 113 International Research Centre of Canada, 66 International Symposium on Research on the Regulation of Human Fertility, 113 Intrauterine device CUDS, 17-18 current use of, 15 effectiveness of, 17, 22,35 inert, 107-108 problems of, 26, 27 products liability litigation and, 121-122, 12~130, 152 regulation of, 92-93, 106 107, 109 risks of, 25, 52, 115 sales of, 60 see also Copper IUDs, Dalkon Shield Investigational Device Exemption (IDE), 108 Investigational New Drug (IND) application, 92,95, 105 In vitro fertilization (IVF), 50 JI.M. and BM. v. Schnud Laboratories, Inc. (1981), 13~135 Johnson & Johnson Products, Inc., 59, 131n Jordan v. Ortho Pharmaceutical Corp. (1985), 132n Judaism, 43~4 Jury Verdict Information Reports, 120 K Korea, contraceptive use in, 21 L Lactation IUD end, 27 oral contraceptives and, 16, 17, 26 Lamanna, Wry Ann, 48 Lambeth Conference, 44 Laparoscopy, 16 Latin America, contraceptive use in, 21 Law and contraceptive development, 45-48, 56 products liability, llS-119, 123-126 products liability case studies, 12~135, 145-146 recommendation for federal products liability statute, 4, 142-146 Lawson v. GOD. Searle & Co. (1976), 132n, 133n Learned intermediary rule, 125, 129, 130 Leiras Pharmaceuticals, 38, 64,66 Lerner, Irwin S., 127 Less developed countries, 7, 8,28 contraceptive use in, 21, 148 regulation in, 103, 112-113 Levonorges~el, 33, 38, 64 Lexis Pharmaceuticals, Inc.,61 LEXIS Service, 120 Liability, strict, 125-126, 129-130, 134, 143 Liability insurance, 39, 130 and contraceptive development, 137-140 industry, 12~127, 135-137, 139 policy holders, 139-140 sources of data, 119-121 see also Products liability law Lilly, Eli, & Co., 59

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INDEX 1 87 Lippes Loop, 108, 122, 127, 128, 129 Mifegyne,39 Long-tailed lines of insurance, 135 Mifepristone,39 Lukaszewicz v. Ortho Pharmaceutical Minicondom,36 Corp. (1981), 131 Minilaparotomy, 16 Luteinizing hormone-releasing Minipill, 17, 27 hormone (LHRH) analogues, 31, Minorities 34, 66-67 Lutheran church, 44 M MacArthur, John D. and Catherine T., Foundation, 82 MacDonald v. Ortho Ph~rmaceuiical Corp. (1985), 131, 132, 145 McEwen v. Ortho Pharmaceutical Corp. (1974), 131, 132, 145 Male methods current use of, 21, 22,53 research status, 34-35 see also Condoms, Vasectomy Marder v. G.D. Searle & Co. (1986), 12~129 Marriage, 44 Matemal deaths, 23, 24 May v. Parke Davis and Co. (1985), 132 Mead Data Central, Inc., 120 Mead Johnson & Company, 59,120 Medical Device Amendments to the FFDCA (1976), 94, 107,108, 127n Medical devices liability law, 126 regulation of, 89,106-109 Medical malpractice, 135,139, 140 Mellon, Andrew W., Foundation, 58, 65, 80, 82, 84, 85~87 Menstrual periods, 15,17, 32, 38 Merck, Sharp & Dohme Company, 59 Merhige, Robert, Jr., 128 Microcapsules,32 Microspheres, 32, 60-61, 66 contraceptive use, 42, 47, 53 in research, 87, 150 Misrepresentation, fraudulent, 124, 143 Monoclonal antibodies, 35 Moody, Jim, 70 Mortality in abortion, 23 Depo-Provera and, 97 DaLkon Shield and, 127 in pregnancy, 24 stenlizabon and, 25 Multiload IUD, 39 N National Academy of Sciences, 75 National Institute of Child Health and Human Development (NICEID), 78-79, 82 Center for Population Research (CPR), 58,70,75 funding by, 58, 75, 81 National Institute on Population and Human Reproduction (proposed), 70 National Institutes of Heals (NIH), 59,61,68,75,78 contraceptive development funding, 58, 65,66, 77, 86, 88 fellowship grants, 84~5 reproductive biology funding, 56, 81 National Science Foundation (NSF), 70,81 Natural family planning methods, 19, 25,35

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188 INDEX Negligence, 125, 129, 134, 143 Nepal, 112 Netherlands, 111 New Chemical Entities (NCE), 105-106 New Drug Application ~DA), 92, 105, 109, 111 New Jersey, ll9n Nonprofit organizations contraceptive development by, 1, 62~4, 70, 87, 149-150 funding by, 5~57, 58 funding of, 76 and liability insurance, 137 Norethindrone (NEI), 32 Norgestimate, 32,35 Nonnylpill, 131n, 132 Noristerat,38 Norlestrin, 132 NORPLANT@, 27,38,47 development of, 63 64, 66 FDA approval application, 31,67, 92 Northwestern University, 61~2 Norway, 84, 111 o OBIGY~Litigation Reporter, 120 Obscenity, 45 Octoxynol-9, 133-134 Office of Technology Assessment, 31 Ohio, ll9n Oklahoma, 47 Oral contraceptives and cancer risk, IS, 16-17, 25 current use of, 14, 15, 20 effectiveness of, 1~17, 22, 52 generic, 61 market for, 60, 68 modification of, 35 products liability and, 121, 122, 13~133, 145 progestin-only (minipill), 17, 27 regulation of, 96, 109, 113 side effects, 25, 26,93 risks of, 24, 32, 110, 130, 148, 151 Oregon, lion Organon, Inc., 39, 59 Ortho-Gynol con~acep~ave jelly, 133-134 Ortho-Novum pill, 131n, 132 Ortho Pharmaceutical Corporation contraceptive development, 59, 60, 61,66-67,76, 77-78 and products liability, 120, 122, 129-130, 131-132, 133, 139, 14~146 Ortho Pharmaceutical Corp. v. Heath (1986), 130n, 145 Ortho survey (1987), 22 Osmotic pills, 33 Ovablock silicone plugs, 39 Ovarian cancer, IS, 1~17 Ovral pill, 131n, 132 Ovulation detection of, 31, 35 oral contraceptives and, 15, 16, 17 suppression of, 32, 34 Ovutimer, 35 p Packard, David and Lucite, Foundation, 82 Panty condom, 36 ParaGard IUD (Copper T380A), 17, 31,61, 122 Parke-Davis ~ Company, 59, 120, 132, 139 Patent life, 105-106, 112, 116 Patent and Trademark Office, 105 Paul VI, 44 Pelvic infections, 15, 16, 127 Pelvic inflammatory disease (PID), 15, 17-18,25, 12~129

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INDEX 189 Periodic abstinence, 19,35,44 current use of, 15 effectiveness of, 19, 22,25 Pharmaceutical industry contraceptive development, 1, 58, 59 60, 64, 6~68, 70, 149 patents and, 105 and products liability, 11~119, 120, 135, 137, 151-152 regulation end, 89, 111-112 research funding, 76, 77-78, 87 see also Private sector Pharmaceutical Litigation Reporter, 120 Pharmaceutical Manufacturers Association, 77 Physicians' Desk Reference, 130 Pin, see Oral contraceptives Pius XI, 44 Pituitary gland, 34 Planned Parenthood Federation of America, 52, 53, 63, 82, 139 Population Council, 56 contraceptive development funding by, 69, 76,77, 80 contraceptive development research, 62, 63, 64, 66, 67 funding of, 82 and liability insurance, 137 Population growth, 12,45 Postmarketing surveillance, 113 current inadequacy of, 110 FDA requirements, 93, 99 recommendations on, 3, 4,115, 143 Potassium, 35 Pregnancy, 33 diagnosis of, 50 ectopic, 15, 17, 37, 128-129 risks of, 2, 7, 12, 103, 117, 148, 151 teenage, 147 Pregnancy, accidental, see Contraceptives, effectiveness of Premarketing Approval Application (PMA),93, 109 Privacy, right to, 45~6,48 Private foundations, 76, 7S, 80, 82-83, 87~S, 150 see also Nonprofit organizations, specific foundations Private sector funding, 83, 150 research, 55-56, 57, 58 see also Pharmaceutical industry Product Liability Risk Retention Act (1981), 140 1986 amendments to, 138 Products liability law, 3 - , 115, 116, 123-126 condoms, 122, 123, 13~135 and contraceptive development, 11~119, 137-13S, 151-152 data sources, 119-120 diaphragms, 122-123, 133 insurance crisis, 13~137, 138-140 intrauterine devices, 121-122, 12~130, 152 oral contraceptives, 121, 122, 13~133, 145 recommendation for federal statute, 141-146 spermicides, 121, 122, 133-134, 145-146 Progestasert IUD, 17, 122 Progesterone, 16, 33,34, 39,50 antiprogesterone, 39 Progestin-only oral contraceptives (minipill), 17, 27 Progestins, 32, 33 Program for Appropriate Technology in Health (PATH), 56, 63, 66 Propranolol, 36 Prostaglandin analogues, 31, 39 Prostaglandins, 51 Protestantism,,14 45 Public Health Service Act (1982 & Supp. 1988), 89

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19O INDEX Public opinion,41,48, 94 Pure Food and Drugs Act (1906>, 93-94 R Reagan, Ronald, 70 Reeder v. Hammond (1983), 13 In Regulation changes recommended for, 114-116 and con~acep~ve development, 2-3, 63-64, 89-94, 15~151 of drug effectiveness, 101-106 of drug safety, 3, 95-101 of insurance rates, 140 of medical devices, 10~ 109 outside United States, 11~114 postmarketing surveillance, 110 see also Food and Drug Administration Religion, 43-45, 53 Reproductive biology, 79, 80, 150 Reproductive endocrinology, 81 Research, 148-149 animal studies, 92, 95, 9~99, 100, 106, 132, 145 collaborative efforts, 6~69 current status of, 1, 3~31 on female methods, 31-34 funding, 70, 75-76, 80 on male methods, 34-35 on modifications of existing methods, 35-37 nonprofit organization, 62~4 outside United States, 37-39, 55 personnel in, 86, 87, 149-150 postmarketing surveillance, 110 private sector, 55-56, 57, 58, 59~1 public sector, 1, 56, 70, 149 university, 61-62 see also Clinical Dials Restatement (Second) of Torts, 118-119, 125, 129-130 Rhythm method, see Periodic abstinence Risk retention groups, 138, 139, 140 Robins, A.H., Company, Inc., 120, 121, 122, 127-128 Rockefeller Foundation, 58, 65, 66, 77,80, 82,84, 87 Rockefeller University, 63 Roe v. Wade (1973),47-48 Romero v. GD. Searle & Co. (1987), 129 Roosevelt, Theodore, 51 Roussel-Uclaf, 39, 59 RUG 86, 39,49, 5~51 S Safety requirements, contraceptive, 3, 95-101, 115, 152 FDA and, 12, 104, 117, 119 see also Regulation Saf-T-Coil IUD, 122, 127 Salk Institute, 66 67 Schering, AG, 38,59 Schmid Laboratories, Inc., 120, 122, 13~135 Scientists recommendations for support, 87 Paining of, ~86 university, 61~2,67 Sclerosing chemicals, 37 Searle, G.D., & Company, 120 contraceptive development, 36,59 and products liability, 128-129, 130, 131n, 132n, 133n, 137-138, 139 Seley v. GD. Searle & Co. (1981), 133n Self-insurance, 138, 139, 140 Sex, attitudes toward, 43, 44 Sex education, 29

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INDEX 191 Sexually transmitted diseases, 2, 12 contraceptive protection against, 15,18-19,25, 36 `'Shug" device, 37 Side effects, 21 clinical testing and, 100 101 of contraceptives currently in use, 15,16-17,20, 130 of contraceptives under development, 32, 33,34, 35, 93 risks of, 24-25 safety standards and, 2,102, 152 Skinner, Jack, 47 Skinner v. Oklahoma (1942),46-47 Smoking, 15,24, 117, 148 Sperm, 3~35 Sperm antigens, 34 Spermicides, 36 effectiveness of, 19, 22 products liability and, 121, 122, 133-134, 145-146 Spinden v. Johnson & Johnson (1981), 131n States contraceptive laws, 45, 46-47, 48 legislatures, 123, 140 liabilitylaws,4, 11~119, 134, 142, 144 Statute, federal products liability, 4, 142-146 Sterilization altitudes toward, 46~7 clips, 107-108 complications in, 25 current use of, 14,2~21,49, 147 effectiveness of, 16, 22 female, 14, 16, 2~21, 36, 39 male, 14-19,20,37,67 research on, 3~37 reversible, 36, 37 Steroidal methods, see Contraceptive steroids Stolle Research and Development Corporation, 6~61, 66-67, 78 and liability insurance, 137 Strict liability, 125-126, 129-130, 134, 143 Subdermal implants, 27 see also Contraceptive implants, NORPLANT~ Sweden, 84, 111 Syntex Laboratories, Inc., 59, 120, 131n, 139 T Tatum-T IUD, 122, 130 Taylor v. Wyeth Laboratories, Inc. (1984), 132 Texas, ll9n Today contraceptive sponge, 31, 60, 63,66,78 FDA approval of, 94, 104 Tort law, 123, 135, 136, 142, 146 strict liability in, 125-126 see also Law Toxicological testing current regulatory requirements, 9~97, 109, 111-112, 15~151 recommended changes in, 115-116 Toxic shock syndrome, 19, 133 Training, research, 84~6, 87 recommendations for, 87 Transcervical sterilization, 37 Transdermal patches, 33 Tnphasic pills, 31 Tubal occlusion plugs, 107-108 Tubal pregnancy, 37 U Uniform Commercial Code, 118-119, 124 Uniform Product Liability Act (1979), 123 United Kingdom, 84, 99, 111 United Nations, 77

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1 92 INDEX United Nations Development Programme (tlNDP), 65, 84 United Nations Fund for Population Activities (UMBRA), 65, 84 United States Constitution, 46, 48 Deparanent of Agriculture, 81 Department of Commerce, 105 DeparOnent of Energy, 81 Deparunent of Health and Human Services, 56,80 federal products liability statute (recommenced), 4, 142-146 Supreme Court, 45~8 see also Agency for International Development, Food and Dmg Administration United States Congress and contraceptive development, 53, 84,99, 104, 116 and products Liability, 4, 123, 142, 152 regulatory legislation, 93-94, 100, 108, 127n United States government contraception policies, 12 contraceptive development funding, 56, 58, 64~5, 75-76, 78~1, 84,87-88,150 and family planning programs, 42 research, 1, 56, 70, 149 Universities, 61-62, 67 Upjohn Company, 38, 59, 97, 99, 100 Urinary estrogen essays, 35 User perspective 52 Uterine cancer, 15, 1~17 Uterus, perforation of, 25,128-129 V Vaccines, contraceptive, 33-34, 39~0, 89,146 Vaginal contraceptives current use of, 15,19, 20 products liability and, 133-134 regulation of, 109 Vaginal ring,31,32-33, 66 Vas deferens, 16,37 Vasectomy complications in, 25 current use of, 1~19,20 nonsurgical, 37, 67 Vastech Medical Products, Inc., 67 Vaughn v. GOD. Searle & Co. (1975), 133n Veterans Administration, 81 Viability, 48 Virginia, 46 VLI Corporation, 60,61, 63, 66 W Wa~rantr, 124,129, 134, 143 Watson Laboratories, 61 Webster v. Reproductive Health Services (1989),48 Wells v. Ortho Pharmaceutical Corp. (1985), 133-134, 145-146 Whitehall Laboratories, Inc., 60, 120 Withdrawal method, 15,20, 22 Women attitudes toward con~acep~ves, 51-53, 54 benefits of contraception to, 12 contraceptive use, 14, 2~21, 25, 38 privacy right of, 48 in research, 150 see also Female methods Wooderson v. Ortho Pharmaceutical Corp. (1984), 132 World Bank, 56, 65, 77, 84 World Health Organization (WHO) contraceptive development, 32,63 dMg regulations, 97,98, 113-114, 15~151 research, 55, 56, 65-66 research funding, 61, 68, 69, 83-84

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INDEX 1 93 Special Programme of Research, Development, and Research Training in Human Reproduction (HRP), 8, 55, 59, 65~6, 69, 83, 86, 87 Wyeth Laboratories, Inc., 38, 64, 120 132 Wye~-Ayerst Laboratories Division, 59, 66 z Zimbabwe, 112