F DA I N T H E 2 S T C E N T U R Y THE CHALLENGES OF REGULATING DRUGS AND NEW TECHNOLOGIES EDITED BY HOLLY FERNANDEZ LYNCH I. GLENN COHEN AND 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 New York Columbia University Press Publishers Since 1893 New York Chichester, West Sussex cup.columbia.edu Copyright © 2015 Columbia University Press All rights reserved Library of Congress Cataloging-in-Publication Data FDA in the twenty-first century : the challenges of regulating drugs and new technologies / Edited by Holly Fernandez Lynch and I. Glenn Cohen. pages cm Includes bibliographical references and index. ISBN 978-0-231-17118-2 (cloth : alk. paper) — ISBN 978-0-231-54007-0 (e-book) 1. United States. Food and Drug Administration. 2. Drugs–Law and legislation–United States. I. Lynch, Holly Fernandez, editor. II. Cohen, I. Glenn, editor. III. Title: Food and Drug Administration in the twenty-first century. KF3871.F34 2015 363.19'20973–dc23 2015001340 Columbia University Press books are printed on permanent and durable acid-free paper. This book is printed on paper with recycled content. Printed in the United States of America c 10 9 8 7 6 5 4 3 2 1 Cover design: Noah Arlow References to websites (URLs) were accurate at the time of writing. Neither the author nor Columbia University Press is responsible for URLs that may have expired or changed since the manuscript was prepared. To Philip Katz, for nurturing a young associate’s interest in FDA, even if she didn’t know anything about anything. —HFL To Auntie Choco and Lily, redheads in Heaven whom I will never forget. —IGC Contents Acknowledgments xiii Introduction Holly Fernandez Lynch and I. Glenn Cohen 1 chapter one Historical Themes and Developments at FDA Over the Past Fifty Years Peter Barton Hutt 17 PART ONE FDA in a Changing World Introduction Holly Fernandez Lynch 35 chapter two A Global and Innovative Regulatory Environment for the U.S. FDA Howard Sklamberg and Jennifer Devine 39 chapter three FDA and the Rise of the Empowered Patient Lewis A. Grossman 59 viii Contents chapter four After the FDA: A Twentieth-Century Agency in a Postmodern World Theodore W. Ruger 76 chapter five The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007 Barbara J. Evans 92 PART TWO Preserving Public Trust and Demanding Accountability Introduction Christopher Robertson 109 chapter six Global Trends Toward Transparency in Participant-Level Clinical Trials Data Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer 115 chapter seven Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties Genevieve Pham-Kanter 134 chapter eight The Crime of Being in Charge: Executive Culpability and Collateral Consequences Katrice Bridges Copeland 146 Contents ix chapter nine Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health Patrick O’Leary 162 PART THREE Protecting the Public Within Constitutional Limits Introduction I. Glenn Cohen 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 184 chapter eleven The FDCA as the Test for Truth of Promotional Claims Christopher Robertson 204 chapter twelve 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 219 PART FOUR Timing Is Everything: Balancing Access and Uncertainty Introduction W. Nicholson Price II 247