LEADER 06001nam 2200649Ia 450 001 9910818451503321 005 20200520144314.0 010 $a1-280-21282-9 010 $a9786610212828 010 $a0-309-56452-2 010 $a0-585-15520-8 035 $a(CKB)110986584750932 035 $a(OCoLC)607897730 035 $a(CaPaEBR)ebrary10056789 035 $a(SSID)ssj0000137784 035 $a(PQKBManifestationID)11148120 035 $a(PQKBTitleCode)TC0000137784 035 $a(PQKBWorkID)10088625 035 $a(PQKB)10548696 035 $a(MiAaPQ)EBC3376516 035 $a(Au-PeEL)EBL3376516 035 $a(CaPaEBR)ebr10056789 035 $a(OCoLC)697625543 035 $a(EXLCZ)99110986584750932 100 $a20040926d1990 my 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aDeveloping new contraceptives $eobstacles and opportunities /$fLuigi Mastroianni, Jr., Peter J. Donaldson, and Thomas T. Kane, editors 205 $a1st ed. 210 $aWashington, D.C. $cNational Academy Press$d1990 215 $a1 online resource (205 pages) $cillustrations 300 $aBibliographic Level Mode of Issuance: Monograph 311 0 $a0-309-08352-4 311 0 $a0-309-04147-3 320 $aIncludes bibliographical references and index. 327 $aDeveloping New Contraceptives -- Copyright -- Preface -- Acknowledgments -- Contents -- Executive Summary -- THE NEED FOR NEW CONTRACEPTIVES -- FDA REGULATION OF CONTRACEPTIVE PRODUCTS -- PRODUCTS LIABILITY LAW AFFECTING CONTRACEPTIVES -- CONCLUSION -- 1 Introduction -- ORGANIZATION -- 2 The Need for New Contraceptives -- CURRENT CONTRACEPTIVE USE -- Contraceptive Practice -- Contraceptive Effectiveness -- POTENTIAL EFFECTS OF NEW CONTRACEPTIVES -- Reducing Abortions -- Contraception and Health -- Reducing the Problems Associated with Existing Methods -- Increasing the Coverage and Quality of Contraceptive Services -- THE IMPORTANCE OF CONTRACEPTIVE DELIVERY -- CONCLUSION -- 3 The Current Status of Contraceptive Research -- RESEARCH LEADS -- Female Methods -- Male Methods -- Modifications of Existing Methods -- METHODS AVAILABLE OUTSIDE THE UNITED STATES -- CONCLUSION -- 4 Values and Contraceptive Development -- ROOTS OF AMERICAN VALUES ON CONTRACEPTION -- Historical Perspectives -- Religious Perspectives -- Legal Perspectives -- CONTEMPORARY VALUE CONFLICTS: STERILIZATION AND ABORTION -- The Link Between Contraceptive Development and Abortion -- RU-486 -- WOMEN'S PERSPECTIVES ON REPRODUCTION AND SOCIAL ROLES -- CONCLUSION -- 5 Organizational Structure of Contraceptive Development -- A DIVERSITY OF EXPERTISE -- The Pharmaceutical Industry -- Small Firms -- Universities -- Nonprofit Organizations -- Government and Private Funding Organizations -- The World Health Organization -- COLLABORATIVE EFFORTS IN CONTRACEPTIVE DEVELOPMENT -- Industry-University Collaboration -- Competitive Aspects of Contraceptive Development -- International Collaboration -- STRENGTHENING THE PROCESS OF CONTRACEPTIVE DEVELOPMENT -- Developing Country Institutions -- National Scientific Centers in the United States -- CONCLUSION -- 6 Funding for Contraceptive Development. 327 $aFUNDING FOR CONTRACEPTIVE DEVELOPMENT -- Pharmaceutical Industry Funding -- Federal Funding -- Foundation Funding -- Funding Worldwide -- World Health Organization -- TRAINING -- RECOMMENDATIONS -- CONCLUSION -- 7 Regulation and Contraceptive Development -- THE DEVELOPMENT PROCESS -- THE REGULATION PROCESS -- FDA's Regulation of Drugs -- Standards of Approval: Safety -- Toxicological Testing of Contraceptive Drugs -- The Case of Depo-Provera -- The Appropriateness of Current Safety Requirements for Contraceptive Drugs -- Standards of Approval: Effectiveness -- The Risk-Benefit Trade-off -- Patent Life and Profitability -- FDA's Regulation of Medical Devices -- Impediments to FDA Approval -- Postmarketing Surveillance -- CONTRACEPTIVE REGULATION: AN INTERNATIONAL PERSPECTIVE -- Regulation in Europe -- Regulation in Developing Countries -- The World Health Organization's Role -- RECOMMENDATIONS -- CONCLUSION -- 8 Products Liability and Contraceptive Development -- THE LEGAL TERRAIN -- SOURCES OF DATA -- TRENDS IN LITIGATION INVOLVING CONTRACEPTIVES -- Intrauterine Devices -- Oral Contraceptives -- Other Contraceptives -- PRODUCTS LIABILITY RULES -- Warranty -- Fraudulent Misrepresentation -- Negligence -- Strict Liability in Tort -- CASE STUDIES -- The Dalkon Shield Intrauterine Device -- Other Intrauterine Devices -- Oral Contraceptives -- Other Contraceptives -- PRODUCTS LIABILITY INSURANCE AND CONTRACEPTIVE DEVELOPMENT -- Causes of the Insurance Crisis -- Cost and Availability of Liability Insurance for Contraceptives -- Responses to the Crisis -- Responses by Insurers -- Responses by Policy Holders -- Responses by State Legislatures -- CONCLUSIONS AND RECOMMENDATIONS -- Possible Elements of a Statute -- The FDA Defense -- Effect on Products Liability Cases -- CONCLUSION -- 9 Contraceptive Development: Obstacles and Opportunities. 327 $aTHE NEED FOR NEW METHODS -- RESEARCH LEADS -- VALUES -- ORGANIZATIONS AND RESOURCES -- REGULATION -- LIABILITY -- A FINAL WORD -- References -- Legal Cases Related to Contraceptive Development -- Glossary -- Index. 606 $aContraceptives$xResearch$zUnited States 606 $aContraceptive drugs$xResearch$zUnited States 615 0$aContraceptives$xResearch 615 0$aContraceptive drugs$xResearch 676 $a613.9/4 701 $aMastroianni$b Luigi$01629324 701 $aDonaldson$b Peter J$0638296 701 $aKane$b Thomas T.$f1951-$01629325 712 02$aCommittee on Contraceptive Development (U.S.) 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910818451503321 996 $aDeveloping new contraceptives$93966986 997 $aUNINA