Pharmaceutical Safety Withdrawals: A Comparative Study of the United States and Canada By Dominika Jegen

Table of Contents

List of Figures

List of Abbreviations

Introduction


Chapter 1: Actor Network Theory

1.1. Examining the Importance of Actors

1.2. Actors Form Actor Networks

1.3. Translation

1.4. The Examination of Black Boxes


Chapter 2: Methods


Chapter 3: Description

3.1. The Drug Approval Process of Health Canada

3.2. The Drug Approval Process of the FDA

3.3. What Happens Once a Pharmaceutical Is Approved?

3.4. Financial Matters and Reviewing Pharmaceutical Applications

3.5. Linking International Pharmaceutical Control Agencies


Chapter 4: The Pharmaceutical Networks

4.1. Approving Pemoline for Sale

4.2. Withdrawing Pemoline From the Market

4.3. Approving Tolcapone for Sale 55

4.4. Withdrawing Tolcapone Off the Canadian Market


Chapter 5: Analysis

5.1. Discussing the Networked Actors

5.2. The Role of Scientifi c Publications

5.3. The Role of User Fees

5.4. The Role of Physicians in Marketing Practices

5.5. Failure of the Black Box—Adverse Reaction Reports

5.6. Analyzing International Links

5.7. Analyzing Differences Between Canada and the United States

5.8. Implications for Current Regulatory Thinking


Chapter 6: Conclusion

6.1. The Limitations of Actor Network Theory (ANT)

6.2. Examining the Limitations of My Research

6.3. Relating to the Larger Network


References

Index