FDA in the Twenty-First Century

The Challenges of Regulating Drugs and New Technologies

Edited by Holly Fernandez Lynch and I. Glenn Cohen

Columbia University Press

FDA in the Twenty-First Century

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Pub Date: September 2015

ISBN: 9780231171182

568 Pages

Format: Hardcover

List Price: $65.00£54.95

Pub Date: September 2015

ISBN: 9780231540070

568 Pages

Format: E-book

List Price: $64.99£54.95

FDA in the Twenty-First Century

The Challenges of Regulating Drugs and New Technologies

Edited by Holly Fernandez Lynch and I. Glenn Cohen

Columbia University Press

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.

The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
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
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

Read the introduction:

About the Author

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.