Holly Fernandez Lynch, "FDA in the
October 28, 2015 In September 2015, Columbia University Press published FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen. This edited volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future. This event provided a discussion of the book, including questions like: How is the agency faring in the 21st century? What are the greatest challenges to the FDA’s success, and what does success look like? What lessons has it learned and how can it best meet the challenges of today? Should we keep the agency we have, pull it apart, or rebuild from scratch? Sponsored by the Harvard Law School Library and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. For more information, visit our website: http://petrieflom.law.harvard.edu/events/details/book-launch-fda-in-the-21st-century.
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Holly Fernandez Lynch, "FDA in the
- 1. FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies October 28, 2015|
- 2. Panelists: • Holly Fernandez Lynch (co-editor) • I. Glenn Cohen (co-editor) • Aaron S. Kesselheim (contributor) • Daniel Carpenter (contributor) Moderator: • Ameet Sarpatwari October 28, 2015|
- 4. 1. Historical Themes and Developments at FDA Over the Past Fifty Years Peter Barton Hutt 2. A Global and Innovative Regulatory Environment for the U.S. FDA Howard Sklamberg and Jennifer Devine 3. FDA and the Rise of the Empowered Patient Lewis A. Grossman 4. After the FDA: A Twentieth-Century Agency in a Postmodern World Theodore W. Ruger 5. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007 Barbara J. Evans Part 1. FDA in a Changing World October 28, 2015|
- 5. 6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer 7. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties Genevieve Pham-Kanter 8. The Crime of Being in Charge: Executive Culpability and Collateral Consequences Katrice Bridges Copeland 9. Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health Patrick O'Leary Part 2. Preserving Trust, Demanding Accountability October 28, 2015|
- 6. 10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection Aaron S. Kesselheim and Michelle M. Mello 11. The FDCA as the Test for Truth of Promotional Claims Christopher Robertson 12. 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 3. Public Protection within Constitutional Limits October 28, 2015|
- 7. 13. Speed Versus Safety in Drug Development R. Alta Charo 14. Overcoming "Premarket Syndrome": Promoting Better Postmarket Surveillance in an Evolving Drug Development Context Shannon Gibson and Trudo Lemmens 15. FDA's Public Health Imperative: An Increased Role for Active Postmarket Analysis Efthimios Parasidis Part 4. Balancing Access and Uncertainty October 28, 2015|
- 8. 16. The Drug Efficacy Study and Its Manifold Legacies Daniel Carpenter, Jeremy Greene, and Susan Moffitt 17. Drug Safety Communication: The Evolving Environment Geoffrey Levitt 18. Innovation Policy Failures in the Manufacturing of Drugs W. Nicholson Price II Part 5. Old and New Issues in Drug Regulation October 28, 2015|
- 9. 19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena Kate Greenwood 20. FDA, Negotiated Rule Making, and Generics: A Proposal Marie Boyd 21. The "Follow-On" Challenge: Statutory Exclusivities and Patent Dances Arti Rai 22. FDA Regulation of Biosimilars Henry Grabowski and Erika Lietzan Part 6. Regulatory Exclusivities and Generics October 28, 2015|
- 10. 23. Analog Agency in a Digital World Nathan Cortez 24. Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine Margaret Foster Riley 25. Device-ive Maneuvers: FDA's Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing Elizabeth R. Pike and Kayte Spector-Bagdady 26. A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records Andrew English, David Rosenberg, and Huaou Yan 27. Race and the FDA Jonathan Kahn Part 7. FDA’s Role in Regulating New Tech October 28, 2015|