FDA in the Twenty-First Century:

The Challenges of Regulating Drugs and New Technologies

October 28, 2015 |

Panelists: • Holly Fernandez Lynch (co-editor) • I. Glenn Cohen (co-editor) • Aaron S. Kesselheim (contributor) • Daniel Carpenter (contributor) Moderator: • Ameet Sarpatwari

October 28, 2015 |

October 28, 2015 |

1. Historical Themes and Developments at FDA Over the Past Fifty Years

Peter Barton Hutt 2. A Global and Innovative Regulatory Environment for the U.S. FDA Howard Sklamberg and Jennifer Devine 3. FDA and the Rise of the Empowered Patient Lewis A. Grossman 4. After the FDA: A Twentieth-Century Agency in a Postmodern World Theodore W. Ruger 5. The Future of Prospective Medicine Under the Food and Drug

Administration Amendments Act of 2007 Barbara J. Evans

Part 1. FDA in a Changing World

October 28, 2015 |

6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data

Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer 7. Conflicts of Interest in FDA Advisory Committees: The Paradox of

Multiple Financial Ties Genevieve Pham-Kanter 8. The Crime of Being in Charge: Executive Culpability and Collateral

Consequences Katrice Bridges Copeland 9. Recalibrating Enforcement in the Biomedical Industry: Deterrence

and the Primacy of Protecting the Public Health Patrick O'Leary

Part 2. Preserving Trust, Demanding Accountability

October 28, 2015 |

10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection

Aaron S. Kesselheim and Michelle M. Mello 11. The FDCA as the Test for Truth of Promotional Claims Christopher Robertson 12. Why FDA's Ban on Off-Label Promotion Violates the First

Amendment: A Study in the Values of Commercial Speech Protection

Coleen Klasmeier and Martin H. Redish

Part 3. Public Protection within Constitutional Limits

October 28, 2015 |

13. Speed Versus Safety in Drug Development R. Alta Charo 14. Overcoming "Premarket Syndrome": Promoting Better Postmarket

Surveillance in an Evolving Drug Development Context Shannon Gibson and Trudo Lemmens 15. FDA's Public Health Imperative: An Increased Role for Active

Postmarket Analysis Efthimios Parasidis

Part 4. Balancing Access and Uncertainty

October 28, 2015 |

16. The Drug Efficacy Study and Its Manifold Legacies Daniel Carpenter, Jeremy Greene, and Susan Moffitt 17. Drug Safety Communication: The Evolving Environment Geoffrey Levitt 18. Innovation Policy Failures in the Manufacturing of Drugs W. Nicholson Price II

Part 5. Old and New Issues in Drug Regulation

October 28, 2015 |

19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena Kate Greenwood 20. FDA, Negotiated Rule Making, and Generics: A Proposal Marie Boyd 21. The "Follow-On" Challenge: Statutory Exclusivities and Patent

Dances Arti Rai 22. FDA Regulation of Biosimilars Henry Grabowski and Erika Lietzan

Part 6. Regulatory Exclusivities and Generics

October 28, 2015 |

23. Analog Agency in a Digital World Nathan Cortez 24. Twenty-First-Century Technology with Twentieth-Century

Baggage: FDA Regulation of Regenerative Medicine Margaret Foster Riley 25. Device-ive Maneuvers: FDA's Risk Assessment of Bifurcated

Direct-to-Consumer Genetic Testing Elizabeth R. Pike and Kayte Spector-Bagdady 26. A New Regulatory Function for E-Prescriptions: Linking FDA to

Physicians and Patient Records Andrew English, David Rosenberg, and Huaou Yan 27. Race and the FDA Jonathan Kahn

Part 7. FDA’s Role in Regulating New Tech

October 28, 2015 |

October 28, 2015 |