FDA in the Twenty-First Century

568 Pages·2.644 MB·English

by  Cohen, I. Glenn;Lynch, Holly Fernandez

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