Chapters in this book

1. Frontmatter i
2. Contents vii
3. Acknowledgments xiii
4. Introduction 1
5. Chapter One. Historical Themes and Developments at FDA Over the Past Fifty Years 17
6. PART ONE. FDA in a Changing World
7. Introduction 35
8. Chapter Two. A Global and Innovative Regulatory Environment for the U.S. FDA 39
9. Chapter Three. FDA and the Rise of the Empowered Patient 59
10. Chapter Four. After the FDA 76
11. Chapter Five. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007 92
12. PART TWO. Preserving Public Trust and Demanding Accountability
13. Introduction 109
14. Chapter Six. Global Trends Toward Transparency in Participant-Level Clinical Trials Data 115
15. Chapter Seven. Conflicts of Interest in FDA Advisory Committees 134
16. Chapter Eight. The Crime of Being in Charge 146
17. Chapter Nine. Recalibrating Enforcement in the Biomedical Industry 162
18. PART THREE. Protecting the Public Within Constitutional Limits
19. Introduction 179
20. Chapter Ten. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection 184
21. Chapter Eleven. The FDCA as the Test for Truth of Promotional Claims 204
22. Chapter Twelve. Why FDA’s Ban on Off-Label Promotion Violates the First Amendment 219
23. PART FOUR. Timing Is Everything
24. Introduction 247
25. Chapter Thirteen. Speed Versus Safety in Drug Development 251
26. Chapter Fourteen. Overcoming “Premarket Syndrome” 268
27. Chapter Fifteen. FDA’s Public Health Imperative 286
28. PART FIVE. Old and New Issues in Drug Regulation
29. Introduction 303
30. Chapter Sixteen. The Drug Efficacy Study and Its Manifold Legacies 306
31. Chapter Seventeen. Drug Safety Communication 328
32. Chapter Eighteen. Innovation Policy Failures in the Manufacturing of Drugs 343
33. PART SIX. Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
34. Introduction 361
35. Chapter Nineteen. From “Recycled Molecule” to Orphan Drug 366
36. Chapter Twenty. FDA, Negotiated Rulemaking, and Generics 382
37. Chapter Twenty-One. The “Follow-On” Challenge 402
38. Chapter Twenty-Two. FDA Regulation of Biosimilars 414
39. PART SEVEN. New Wine in Old Bottles
40. Introduction 433
41. Chapter Twenty-Three. Analog Agency in a Digital World 438
42. Chapter Twenty-Four. Twenty-First-Century Technology with Twentieth-Century Baggage 455
43. Chapter Twenty-Five. Device-ive Maneuvers 470
44. Chapter Twenty-Six. A New Regulatory Function for E-Prescriptions 486
45. Chapter Twenty-Seven. Race and the FDA 501
46. Contributors 517
47. Index 519