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Index
Cover
Title Page
Copyright
Dedication
Contents
Acknowledgments
Introduction
Chapter One: Historical Themes and Developments at FDA Over the Past Fifty Years
Part One: FDA in a Changing World
Introduction
Chapter Two: A Global and Innovative Regulatory Environment for the U.S. FDA
Chapter Three: FDA and the Rise of the Empowered Patient
Chapter Four: After the FDA: A Twentieth-Century Agency in a Postmodern World
Chapter Five: The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007
Part Two: Preserving Public Trust and Demanding Accountability
Introduction
Chapter Six: Global Trends Toward Transparency in Participant-Level Clinical Trials Data
Chapter Seven: Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties
Chapter Eight: The Crime of Being in Charge: Executive Culpability and Collateral Consequences
Chapter Nine: Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health
Part Three: Protecting the Public Within Constitutional Limits
Introduction
Chapter Ten: Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection
Chapter Eleven: The FDCA as the Test for Truth of Promotional Claims
Chapter Twelve: Why FDA’s Ban on Off-Label Promotion Violates the First Amendment: A Study in the Values of Commercial Speech Protection
Part Four: Timing Is Everything: Balancing Access and Uncertainty
Introduction
Chapter Thirteen: Speed Versus Safety in Drug Development
Chapter Fourteen: Overcoming “Premarket Syndrome”: Promoting Better Postmarket Surveillance in an Evolving Drug-Development Context
Chapter Fifteen: FDA’s Public Health Imperative: An Increased Role for Active Postmarket Analysis
Part Five: Old and New Issues in Drug Regulation
Introduction
Chapter Sixteen: The Drug Efficacy Study and Its Manifold Legacies
Chapter Seventeen: Drug Safety Communication: The Evolving Environment
Chapter Eighteen: Innovation Policy Failures in the Manufacturing of Drugs
Part Six: Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
Introduction
Chapter Nineteen: From “Recycled Molecule” to Orphan Drug: Lessons from Makena
Chapter Twenty: FDA, Negotiated Rulemaking, and Generics: A Proposal
Chapter Twenty-One: The “Follow-On” Challenge: Statutory Exclusivities and Patent Dances
Chapter Twenty-Two: FDA Regulation of Biosimilars
Part Seven: New Wine in Old Bottles: FDA’s Role in Regulating New Technologies
Introduction
Chapter Twenty-Three: Analog Agency in a Digital World
Chapter Twenty-Four: Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine
Chapter Twenty-Five: Device-ive Maneuvers: FDA’s Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing
Chapter Twenty-Six: A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records
Chapter Twenty-Seven: Race and the FDA
Contributors
Index
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