FDA in the Twenty-First Century

Holly Fernandez Lynch is the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. She is a lawyer and bioethicist, with expertise in the ethics and regulation of human-subjects research and drug development. She is also the author of Conflicts of Conscience in Health Care: An Institutional Compromise. I. Glenn Cohen is a professor at Harvard Law School and faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. He is the author of more than eighty articles and book chapters and the author, editor, or coeditor of seven books. In addition to the ethics and regulation of drug development, he works on reproductive technologies, medical tourism, rationing, the bioethics of professional sports, and other topics.

• 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

This book contains a concise historical account of FDA regulation and an insightful analysis of the major challenges the FDA faces over the next quarter century. The contributors, drawn from a variety of fields, are all authorities on the issues at hand. Although they do not share the same opinions, their disagreements make this essay collection remarkably balanced. Essential reading. -- Anup Malani, University of Chicago A truly magisterial collection, FDA in the Twenty-First Century is a must-read for academics, practitioners, and social scientists interested in the future of drug and device regulation. The book's contributors offer thoughtful and well-researched policy approaches on conundrums facing the FDA and similar agencies around the world. Bravo! -- Frank Pasquale, University of Maryland, Carey School of Law This insightful and informative book draws on a variety of perspectives to chart a course for the FDA-and society-as we confront the challenges of medical-product regulation in the twenty-first century. It should be read by regulators and the regulated alike, as well as by patients, policy makers, payers, physicians, pharmacists-anyone interested in human health. -- Daniel Troy, general counsel, GlaxoSmithKline PLC, and chief counsel of the FDA from 2001 to 2004 FDA in the Twenty-First Century lives up to its title. Drawing on the historical evolution of the FDA, this book lays out, in a clear and thoughtful manner, key questions for the future. At a time when scientific opportunities are presenting at lightning speed and the expectations of the public for transparency, personalized medicine, and safety have never been greater, this is an important book. -- Amy Rick, Food and Drug Law Institute FDA in the Twenty-First Century does an excellent job of highlighting and explaining... it is a useful source for anyone interested in the nexus of modern medical bureaucracy. -- Devorah Goldman The Weekly Standard [These] essays provide an excellent survey of the growing challenges the FDA faces... Highly recommended. Choice Essential reading for anyone who wants to understand the powerful forces driving the FDA's evolution. -- Norman M. Goldfarb Journal of Clinical Research Best Practices This informative book is a valuable read for lawyers, policymakers, and anyone interested in public health. Harvard Law Review