Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation Book

Preface ix

Part I Property and Progress

1 Rising Expectations-and Diminishing Returns 3

2 Property Generally: Externalities, Coordination, and the Public Domain 13

3 Intellectual Property: The Public Domain and Private Rights 18

Part II Maintaining the Public/Private Interface

4 Taming Conflict of Interests 29

5 Federally Sponsored Research Under Bayh-Dole 35

Part III Intellectual Property and Its Regulation

6 The Anticommons 47

7 The Single Monopoly: Current Patent Limitations 54

8 Rate Regulation: An Unneeded Swamp 66

9 Patent Purchases: A Second Swamp 82

10 Socialization of R&D: The Final Swamp 97

Part IV The FDA: Purity, Safety, Effectiveness

11 The Steady Expansion of FDA Power 109

12 FDA Versus the Individual: Upstream or Downstream Decision Making 113

13 Drug Withdrawal: Too Much, Too Soon 132

Part V Pharmaceutical Marketing

14 Getting the Drugs to Market 143

15 Deceptive Marketing 165

Part VI Liability for Pharmaceuticals

16 Tort Preliminaries 185

17 Product Liability for Prescription Drugs: Manufacturing and Design Cases 194

18 The Main Event: Misrepresentation, Overpromotion, and Duty to Warn 202

Conclusion: Socialized Medicines 237

Notes 241

Index 273