Contents
Acknowledgments
Introduction
Holly Fernandez Lynch and I. Glenn Cohen
CHAPTER ONE
Historical Themes and Developments at FDA Over the Past Fifty Years
Peter Barton Hutt
PART ONE
FDA in a Changing World
Introduction
Holly Fernandez Lynch
CHAPTER TWO
A Global and Innovative Regulatory Environment for the U.S. FDA
Howard Sklamberg and Jennifer Devine
CHAPTER THREE
FDA and the Rise of the Empowered Patient
Lewis A. Grossman
CHAPTER FOUR
After the FDA: A Twentieth-Century Agency in a Postmodern World
Theodore W. Ruger
CHAPTER FIVE
The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007
Barbara J. Evans
PART TWO
Preserving Public Trust and Demanding Accountability
Introduction
Christopher Robertson
CHAPTER SIX
Global Trends Toward Transparency in Participant-Level Clinical Trials Data
Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer
CHAPTER SEVEN
Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties
Genevieve Pham-Kanter
CHAPTER EIGHT
The Crime of Being in Charge: Executive Culpability and Collateral Consequences
Katrice Bridges Copeland
CHAPTER NINE
Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health
Patrick O’Leary
PART THREE
Protecting the Public Within Constitutional Limits
Introduction
I. Glenn Cohen
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
CHAPTER ELEVEN
The FDCA as the Test for Truth of Promotional Claims
Christopher Robertson
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
PART FOUR
Timing Is Everything: Balancing Access and Uncertainty
Introduction
W. Nicholson Price II
CHAPTER THIRTEEN
Speed Versus Safety in Drug Development
R. Alta Charo
CHAPTER FOURTEEN
Overcoming “Premarket Syndrome”: Promoting Better Postmarket Surveillance in an Evolving Drug-Development Context
Shannon Gibson and Trudo Lemmens
CHAPTER FIFTEEN
FDA’s Public Health Imperative: An Increased Role for Active Postmarket Analysis
Efthimios Parasidis
PART FIVE
Old and New Issues in Drug Regulation
Introduction
R. Alta Charo
CHAPTER SIXTEEN
The Drug Efficacy Study and Its Manifold Legacies
Daniel Carpenter, Jeremy Greene, and Susan Moffitt
CHAPTER SEVENTEEN
Drug Safety Communication: The Evolving Environment
Geoffrey Levitt
CHAPTER EIGHTEEN
Innovation Policy Failures in the Manufacturing of Drugs
W. Nicholson Price II
PART SIX
Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
Introduction
Benjamin N. Roin
CHAPTER NINETEEN
From “Recycled Molecule” to Orphan Drug: Lessons from Makena
Kate Greenwood
CHAPTER TWENTY
FDA, Negotiated Rulemaking, and Generics: A Proposal
Marie Boyd
CHAPTER TWENTY-ONE
The “Follow-On” Challenge: Statutory Exclusivities and Patent Dances
Arti Rai
CHAPTER TWENTY-TWO
FDA Regulation of Biosimilars
Henry Grabowski and Erika Lietzan
PART SEVEN
New Wine in Old Bottles: FDA’s Role in Regulating New Technologies
Introduction
Frances H. Miller
CHAPTER TWENTY-THREE
Analog Agency in a Digital World
Nathan Cortez
CHAPTER TWENTY-FOUR
Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine
Margaret Foster Riley
CHAPTER TWENTY-FIVE
Device-ive Maneuvers: FDA’s Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing
Elizabeth R. Pike and Kayte Spector-Bagdady
CHAPTER TWENTY-SIX
A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records
Andrew English, David Rosenberg, and Huaou Yan
CHAPTER TWENTY-SEVEN
Race and the FDA
Jonathan Kahn
Contributors
Index