FDA in the Twenty-First Century

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 | 2015

https://doi.org/10.7312/lync17118

Overview
Contents

About this book

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. 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.

Addresses perennial and new problems and the improvements the FDA can make to better serve the public good.

Author information

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.

Reviews

This informative book is a valuable read for lawyers, policymakers, and anyone interested in public health.

Norman M. Goldfarb:
Essential reading for anyone who wants to understand the powerful forces driving the FDA's evolution.

[These] essays provide an excellent survey of the growing challenges the FDA faces.... Highly recommended.

Devorah Goldman:
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.

Amy Rick, Food and Drug Law Institute:
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.

Daniel Troy, general counsel, GlaxoSmithKline PLC, and chief counsel of the FDA from 2001 to 2004:
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.

Frank Pasquale, University of Maryland, Carey School of Law:
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!

Anup Malani, University of Chicago:
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.

Frontmatter Free access PDF PDF	i
Contents Free access PDF PDF	vii
Acknowledgments Access restricted Content is available PDF PDF	xiii
Introduction Holly Fernandez Lynch and I. Glenn Cohen Access restricted Content is available PDF PDF	1
Chapter One. Historical Themes and Developments at FDA Over the Past Fifty Years Peter Barton Hutt Access restricted Content is available PDF PDF	17
PART ONE. FDA in a Changing World
Introduction Holly Fernandez Lynch Access restricted Content is available PDF PDF	35
Chapter Two. A Global and Innovative Regulatory Environment for the U.S. FDA Howard Sklamberg and Jennifer Devine Access restricted Content is available PDF PDF	39
Chapter Three. FDA and the Rise of the Empowered Patient Lewis A. Grossman Access restricted Content is available PDF PDF	59
Chapter Four. After the FDA Theodore W. Ruger Access restricted Content is available PDF PDF	76
Chapter Five. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007 Barbara J. Evans Access restricted Content is available PDF PDF	92
PART TWO. Preserving Public Trust and Demanding Accountability
Introduction Christopher Robertson Access restricted Content is available PDF PDF	109
Chapter Six. Global Trends Toward Transparency in Participant-Level Clinical Trials Data Alla Digilova, Rebecca Li, Mark Barnes and Barbara Bierer Access restricted Content is available PDF PDF	115
Chapter Seven. Conflicts of Interest in FDA Advisory Committees Genevieve Pham-Kanter Access restricted Content is available PDF PDF	134
Chapter Eight. The Crime of Being in Charge Katrice Bridges Copeland Access restricted Content is available PDF PDF	146
Chapter Nine. Recalibrating Enforcement in the Biomedical Industry Patrick O’Leary Access restricted Content is available PDF PDF	162
PART THREE. Protecting the Public Within Constitutional Limits
Introduction I. Glenn Cohen Access restricted Content is available PDF PDF	179
Chapter Ten. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection Aaron S. Kesselheim and Michelle M. Mello Access restricted Content is available PDF PDF	184
Chapter Eleven. The FDCA as the Test for Truth of Promotional Claims Christopher Robertson Access restricted Content is available PDF PDF	204
Chapter Twelve. Why FDA’s Ban on Off-Label Promotion Violates the First Amendment Coleen Klasmeier and Martin H. Redish Access restricted Content is available PDF PDF	219
PART FOUR. Timing Is Everything
Introduction W. Nicholson Price Access restricted Content is available PDF PDF	247
Chapter Thirteen. Speed Versus Safety in Drug Development R. Alta Charo Access restricted Content is available PDF PDF	251
Chapter Fourteen. Overcoming “Premarket Syndrome” Shannon Gibson and Trudo Lemmens Access restricted Content is available PDF PDF	268
Chapter Fifteen. FDA’s Public Health Imperative Efthimios Parasidis Access restricted Content is available PDF PDF	286
PART FIVE. Old and New Issues in Drug Regulation
Introduction R. Alta Charo Access restricted Content is available PDF PDF	303
Chapter Sixteen. The Drug Efficacy Study and Its Manifold Legacies Daniel Carpenter, Jeremy Greene and Susan Moffitt Access restricted Content is available PDF PDF	306
Chapter Seventeen. Drug Safety Communication Geoffrey Levitt Access restricted Content is available PDF PDF	328
Chapter Eighteen. Innovation Policy Failures in the Manufacturing of Drugs W. Nicholson Price Access restricted Content is available PDF PDF	343
PART SIX. Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
Introduction Benjamin N. Roin Access restricted Content is available PDF PDF	361
Chapter Nineteen. From “Recycled Molecule” to Orphan Drug Kate Greenwood Access restricted Content is available PDF PDF	366
Chapter Twenty. FDA, Negotiated Rulemaking, and Generics Marie Boyd Access restricted Content is available PDF PDF	382
Chapter Twenty-One. The “Follow-On” Challenge Arti Rai Access restricted Content is available PDF PDF	402
Chapter Twenty-Two. FDA Regulation of Biosimilars Henry Grabowski and Erika Lietzan Access restricted Content is available PDF PDF	414
PART SEVEN. New Wine in Old Bottles
Introduction Frances H. Miller Access restricted Content is available PDF PDF	433
Chapter Twenty-Three. Analog Agency in a Digital World Nathan Cortez Access restricted Content is available PDF PDF	438
Chapter Twenty-Four. Twenty-First-Century Technology with Twentieth-Century Baggage Margaret Foster Riley Access restricted Content is available PDF PDF	455
Chapter Twenty-Five. Device-ive Maneuvers Elizabeth R. Pike and Kayte Spector-Bagdady Access restricted Content is available PDF PDF	470
Chapter Twenty-Six. A New Regulatory Function for E-Prescriptions Andrew English, David Rosenberg and Huaou Yan Access restricted Content is available PDF PDF	486
Chapter Twenty-Seven. Race and the FDA Jonathan Kahn Access restricted Content is available PDF PDF	501
Contributors Access restricted Content is available PDF PDF	517
Index Access restricted Content is available PDF PDF	519

FDA in the Twenty-First Century

The Challenges of Regulating Drugs and New Technologies

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