Developing new contraceptives : obstacles and opportunities / / Luigi Mastroianni, Jr., Peter J. Donaldson, and Thomas T. Kane, editors

• Record Nr.: UNINA9910818451503321
• Pubbl/distr/stampa: Washington, D.C., : National Academy Press, 1990
• ISBN: 1-280-21282-9; 9786610212828; 0-309-56452-2; 0-585-15520-8
• Edizione: [1st ed.]
• Descrizione fisica: 1 online resource (205 pages) : illustrations
• Altri autori (Persone): MastroianniLuigi; DonaldsonPeter J; KaneThomas T. <1951->
• Disciplina: 613.9/4
• Soggetti: Contraceptives - Research - United States; Contraceptive drugs - Research - United States
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Bibliographic Level Mode of Issuance: Monograph
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: Developing 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.; FUNDING 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.; THE NEED FOR NEW METHODS -- RESEARCH LEADS -- VALUES -- ORGANIZATIONS AND RESOURCES -- REGULATION -- LIABILITY -- A FINAL WORD -- References -- Legal Cases Related to Contraceptive Development -- Glossary -- Index.