Developing New Contraceptives

Developing New Contraceptives

Obstacles and Opportunities

  • Publisher: National Academies Press
  • ISBN: 9780309083522
  • eISBN Pdf: 9780309564526
  • Place of publication:  United States
  • Year of digital publication: 1990
  • Month: January
  • Pages: 206
  • Language: English

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.

  • 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

Subjects

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