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Developing New Contraceptives Obstacles and Opportunities (1990) / Chapter Skim
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Pages 181-193

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From page 181...
... , 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.
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From page 182...
... ,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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From page 183...
... , 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)
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From page 184...
... , 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)
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From page 185...
... , 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)
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From page 186...
... (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.
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From page 187...
... , 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)
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From page 188...
... , 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)
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From page 189...
... , 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)
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From page 190...
... , 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.
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From page 191...
... (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)
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From page 192...
... , 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.
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From page 193...
... 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
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Key Terms

  • contraceptive development
  • oral contraceptives
  • liability insurance
  • liability law
  • ortho pharmaceutical

  • dalkon shield
  • development funding
  • outside united
  • federal products
  • safety requirements

  • contraceptive steroids
  • family planning
  • female methods
  • postmarketing surveillance
  • medical devices

  • population research
  • reproductive biology
  • research status
  • pharmaceutical corp
  • medical device

  • common law
  • nonprofit organizations
  • liability statute
  • international development
  • product liability

  • toxicological testing
  • occlusion plugs
  • effectiveness requirements
  • strict liability
  • periodic abstinence


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