FDA in the Twenty-First Century
The Challenges of Regulating Drugs and New Technologies
1st Edition
Published on 29. October 2015
568 pages
978-0-231-54007-0 (ISBN)
Description
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.
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. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. 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.
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. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. 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.
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I. Glenn Cohen | Holly Fernandez Lynch
FDA in the Twenty-First Century
The Challenges of Regulating Drugs and New Technologies
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09/2015
Columbia University Press
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Persons
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.
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.
Content
Acknowledgments
Introduction, by Holly Fernandez Lynch and I. Glenn Cohen
1. Historical Themes and Developments at FDA Over the Past Fifty Years, by Peter Barton Hutt
Part 1. FDA in a Changing World
Introduction, by Holly Fernandez Lynch
2. A Global and Innovative Regulatory Environment for the U.S. FDA, by Howard Sklamberg and Jennifer Devine
3. FDA and the Rise of the Empowered Patient, by Lewis A. Grossman
4. After the FDA: A Twentieth-Century Agency in a Postmodern World, by Theodore W. Ruger
5. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007, by Barbara J. Evans
Part 2. Preserving Public Trust and Demanding Accountability
Introduction, by Christopher Robertson
6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data, by Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer
7. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties, by Genevieve Pham-Kanter
8. The Crime of Being in Charge: Executive Culpability and Collateral Consequences, by Katrice Bridges Copeland
9. Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health, by Patrick O'Leary
Part 3. Protecting the Public Within Constitutional Limits
Introduction, by Glenn Cohen
10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, by Aaron S. Kesselheim and Michelle M. Mello
11. The FDCA as the Test for Truth of Promotional Claims, by Christopher Robertson
12. Why FDA's Ban on Off-Label Promotion Violates the First Amendment: A Study in the Values of Commercial Speech Protection, by Coleen Klasmeier and Martin H. Redish
Part 4. Timing Is Everything: Balancing Access and Uncertainty
Introduction, by W. Nicholson Price II
13. Speed Versus Safety in Drug Development, by R. Alta Charo
14. Overcoming "Premarket Syndrome": Promoting Better Postmarket Surveillance in an Evolving Drug Development Context, by Shannon Gibson and Trudo Lemmens
15. FDA's Public Health Imperative: An Increased Role for Active Postmarket Analysis, by Efthimios Parasidis
Part 5. Old and New Issues in Drug Regulation
Introduction, by R. Alta Charo
16. The Drug Efficacy Study and Its Manifold Legacies, by Daniel Carpenter, Jeremy Greene, and Susan Moffitt
17. Drug Safety Communication: The Evolving Environment, by Geoffrey Levitt
18. Innovation Policy Failures in the Manufacturing of Drugs, by W. Nicholson Price II
Part 6. Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
Introduction, by Benjamin N. Roin
19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena, by Kate Greenwood
20. FDA, Negotiated Rule Making, and Generics: A Proposal, by Marie Boyd
21. The "Follow-On" Challenge: Statutory Exclusivities and Patent Dances, by Arti Rai
22. FDA Regulation of Biosimilars, by Henry Grabowski and Erika Lietzan
Part 7. New Wine in Old Bottles: FDA's Role in Regulating New Technologies
Introduction, by Frances H. Miller
23. Analog Agency in a Digital World, by Nathan Cortez
24. Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine, by Margaret Foster Riley
25. Device-ive Maneuvers: FDA's Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing, by Elizabeth R. Pike and Kayte Spector-Bagdady
26. A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records, by Andrew English, David Rosenberg, and Huaou Yan
27. Race and the FDA, by Jonathan Kahn
Contributors
Index
Introduction, by Holly Fernandez Lynch and I. Glenn Cohen
1. Historical Themes and Developments at FDA Over the Past Fifty Years, by Peter Barton Hutt
Part 1. FDA in a Changing World
Introduction, by Holly Fernandez Lynch
2. A Global and Innovative Regulatory Environment for the U.S. FDA, by Howard Sklamberg and Jennifer Devine
3. FDA and the Rise of the Empowered Patient, by Lewis A. Grossman
4. After the FDA: A Twentieth-Century Agency in a Postmodern World, by Theodore W. Ruger
5. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007, by Barbara J. Evans
Part 2. Preserving Public Trust and Demanding Accountability
Introduction, by Christopher Robertson
6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data, by Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer
7. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties, by Genevieve Pham-Kanter
8. The Crime of Being in Charge: Executive Culpability and Collateral Consequences, by Katrice Bridges Copeland
9. Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health, by Patrick O'Leary
Part 3. Protecting the Public Within Constitutional Limits
Introduction, by Glenn Cohen
10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, by Aaron S. Kesselheim and Michelle M. Mello
11. The FDCA as the Test for Truth of Promotional Claims, by Christopher Robertson
12. Why FDA's Ban on Off-Label Promotion Violates the First Amendment: A Study in the Values of Commercial Speech Protection, by Coleen Klasmeier and Martin H. Redish
Part 4. Timing Is Everything: Balancing Access and Uncertainty
Introduction, by W. Nicholson Price II
13. Speed Versus Safety in Drug Development, by R. Alta Charo
14. Overcoming "Premarket Syndrome": Promoting Better Postmarket Surveillance in an Evolving Drug Development Context, by Shannon Gibson and Trudo Lemmens
15. FDA's Public Health Imperative: An Increased Role for Active Postmarket Analysis, by Efthimios Parasidis
Part 5. Old and New Issues in Drug Regulation
Introduction, by R. Alta Charo
16. The Drug Efficacy Study and Its Manifold Legacies, by Daniel Carpenter, Jeremy Greene, and Susan Moffitt
17. Drug Safety Communication: The Evolving Environment, by Geoffrey Levitt
18. Innovation Policy Failures in the Manufacturing of Drugs, by W. Nicholson Price II
Part 6. Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
Introduction, by Benjamin N. Roin
19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena, by Kate Greenwood
20. FDA, Negotiated Rule Making, and Generics: A Proposal, by Marie Boyd
21. The "Follow-On" Challenge: Statutory Exclusivities and Patent Dances, by Arti Rai
22. FDA Regulation of Biosimilars, by Henry Grabowski and Erika Lietzan
Part 7. New Wine in Old Bottles: FDA's Role in Regulating New Technologies
Introduction, by Frances H. Miller
23. Analog Agency in a Digital World, by Nathan Cortez
24. Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine, by Margaret Foster Riley
25. Device-ive Maneuvers: FDA's Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing, by Elizabeth R. Pike and Kayte Spector-Bagdady
26. A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records, by Andrew English, David Rosenberg, and Huaou Yan
27. Race and the FDA, by Jonathan Kahn
Contributors
Index
