FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies (Hardcover)

Acknowledgments
Introduction, by Holly Fernandez Lynch and I. Glenn Cohen
1. Historical Themes and Developments at FDA Over the Past Fifty Years, by Peter Barton Hutt
Part 1. FDA in a Changing World
Introduction, by Holly Fernandez Lynch
2. A Global and Innovative Regulatory Environment for the U.S. FDA, by Howard Sklamberg and Jennifer Devine
3. FDA and the Rise of the Empowered Patient, by Lewis A. Grossman
4. After the FDA: A Twentieth-Century Agency in a Postmodern World, by Theodore W. Ruger
5. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007, by Barbara J. Evans
Part 2. Preserving Public Trust and Demanding Accountability
Introduction, by Christopher Robertson
6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data, by Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer
7. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties, by Genevieve Pham-Kanter
8. The Crime of Being in Charge: Executive Culpability and Collateral Consequences, by Katrice Bridges Copeland
9. Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health, by Patrick O'Leary
Part 3. Protecting the Public Within Constitutional Limits
Introduction, by Glenn Cohen
10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, by Aaron S. Kesselheim and Michelle M. Mello
11. The FDCA as the Test for Truth of Promotional Claims, by Christopher Robertson
12. Why FDA's Ban on Off-Label Promotion Violates the First Amendment: A Study in the Values of Commercial Speech Protection, by Coleen Klasmeier and Martin H. Redish
Part 4. Timing Is Everything: Balancing Access and Uncertainty
Introduction, by W. Nicholson Price II
13. Speed Versus Safety in Drug Development, by R. Alta Charo
14. Overcoming "Premarket Syndrome": Promoting Better Postmarket Surveillance in an Evolving Drug Development Context, by Shannon Gibson and Trudo Lemmens
15. FDA's Public Health Imperative: An Increased Role for Active Postmarket Analysis, by Efthimios Parasidis
Part 5. Old and New Issues in Drug Regulation
Introduction, by R. Alta Charo
16. The Drug Efficacy Study and Its Manifold Legacies, by Daniel Carpenter, Jeremy Greene, and Susan Moffitt
17. Drug Safety Communication: The Evolving Environment, by Geoffrey Levitt
18. Innovation Policy Failures in the Manufacturing of Drugs, by W. Nicholson Price II
Part 6. Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
Introduction, by Benjamin N. Roin
19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena, by Kate Greenwood
20. FDA, Negotiated Rule Making, and Generics: A Proposal, by Marie Boyd
21. The "Follow-On" Challenge: Statutory Exclusivities and Patent Dances, by Arti Rai
22. FDA Regulation of Biosimilars, by Henry Grabowski and Erika Lietzan
Part 7. New Wine in Old Bottles: FDA's Role in Regulating New Technologies
Introduction, by Frances H. Miller
23. Analog Agency in a Digital World, by Nathan Cortez
24. Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine, by Margaret Foster Riley
25. Device-ive Maneuvers: FDA's Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing, by Elizabeth R. Pike and Kayte Spector-Bagdady
26. A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records, by Andrew English, David Rosenberg, and Huaou Yan
27. Race and the FDA, by Jonathan Kahn
Contributors
Index