Conference Description

The Food and Drug Administration, the US government’s oldest comprehensive consumer protection agency, bears the monumental task of safeguarding the public health through regulation of food, drugs and biologics, devices, cosmetics, animal products, radiation-emitting products, and now, tobacco. The agency faces a number of perennial issues related to funding, relationships with industry, and striking the proper balance between consumer choice and consumer protection. It also faces several modern challenges related to globalization, novel technologies, newly added responsibilities, and changing threats to the public health.

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? This conference gathered leading experts from academia, government, and private industry to evaluate the FDA based on these and other questions, and to begin charting a course for the agency’s future.

Conference Schedule

Note: All keynote, plenary, and panel sessions will include time for Q & A.

Friday, May 3, 2013

9:00 – 9:15am: Welcome and Introduction

• I. Glenn Cohen, Faculty Director, Petrie-Flom Center
• Holly Fernandez Lynch, Executive Director, Petrie-Flom Center

9:15 – 10:00am: Plenary 1

• Peter Barton Hutt, Covington & Burling LLP – Historical Themes and Developments Over the Past 50 Years

10:00 – 11:00am: Panel 1, The FDA in a Changing World

• Lewis Grossman, American University, Washington College of Law/Covington & Burling LLP – FDA in the Age of the Empowered Consumer
• Theodore Ruger, University of Pennsylvania Law School – After the FDA: A Twentieth Century Agency in a Postmodern World
• Barbara Evans, University of Houston Law Center – The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007
• Moderator: Holly Fernandez Lynch, Executive Director, Petrie-Flom Center

11:00 – 11:15am: Break

11:15 – 12:30am: Panel 2, Preserving Public Trust and Demanding Accountability

• Mark Lange, Eli Lilly, Data Transparency and the Role of the FDA
• Genevieve Pham-Kanter, Edmond J. Safra Center for Ethics, Harvard University – Financial Conflicts of Interest and Voting in FDA Drug Advisory Committees
• Patrick O’Leary, Harvard Law School – Credible Deterrence: The Park Doctrine and the FDA in the 21st Century
• Katrice Bridges Copeland, Penn State Dickinson School of Law
• Moderator: David Korn, Massachusetts General Hospital – The Crime of Being in Charge: Executive Culpability and Collateral Consequences

12:30 – 12:45pm: Break

12:45 – 1:30pm: Lunch and Keynote

• Introduction by Jeffrey Senger, Sidley Austin
• Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, U.S. Food and Drug Administration

1:30-1:45pm: Break

1:45 – 2:45pm: Panel 3, Protecting the Public Within Constitutional Limits

• Aaron Kesselheim/Michelle Mello, Harvard School of Public Health – The Prospect of Continued FDA Regulation of Manufacturer Promotion in an Era of Expanding Commercial Speech
• Chris Robertson, University of Arizona James E. Rogers College of Law – When Truth Cannot Be Safely Presumed: A First Amendment Reconstruction of the Regulation of Off-Label Drugs
• Jessica Flanigan, University of Richmond – Patients’ Rights, Speech, and Off-Label Marketing
• Moderator: I. Glenn Cohen, Faculty Director, Petrie-Flom Center

2:45 – 3:30pm: Panel 4, Timing Is Everything: Balancing Access and Uncertainty

• Shannon Gibson/Trudo Lemmens, University of Toronto Faculty of Law – Overcoming “Pre-Market Syndrome”: Advancing Post-Market Surveillance in an Evolving Drug Development Context
• Efthimios Parasidis, St. Louis University School of Law. moving to The Ohio State University Moritz College of Law – Innovative Regulating as a Public Health Imperative
• Moderator: Jeff Skopek, Petrie-Flom Center

3:30 – 3:45pm: Break

3:45 – 5:00pm: Panel 5, Major Issues in Drug Regulation

• Geoffrey Levitt, Pfizer – Drug Safety Communication: The Evolving Environment
• W. Nicholson Price II, Petrie-Flom Center – The Role of Innovation Policy in Pharmaceutical Manufacturing
• Ernst Berndt, MIT Sloan School of Management / Rena Conti, University of Chicago – Anatomy of US Cancer Drug Shortages
• Daniel Carpenter, Harvard University, Jeremy Greene, Johns Hopkins School of Medicine, Susan Moffitt, Brown University, Jonathan Warsh, Oxford University – Therapeutic and Economic Effects of Efficacy-Based Drug Withdrawals: The Drug Efficacy Study Initiative and Its Manifold Legacies
• Moderator: R. Alta Charo, University of Wisconsin Law School

Saturday, May 4, 2013

9:00 – 9:05am: Welcome

• I. Glenn Cohen, Excutive Director, Petrie-Flom Center

9:05 – 9:50am: Pleanary 2

• R. Alta Charo, University of Wisconsin Law School, Integrating Speed and Safety

9:50 – 11:05am: Panel 6: Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars

• Kate Greenwood, Seton Hall University School of Law – Calibrated Incentives for Orphan Drug Development: Time to Experiment?
• Kevin Outterson, Boston University School of Law – Ending the Game of Shadows in Drug Regulation
• Marie Boyd, University of South Carolina School of Law – Unequal Protection Under the Law: Reforming the Regulation of Generic Drugs
• Henry Grabowski, Duke University – FDA Regulation of Biosimilars
• Moderator: Benjamin Roin, Petrie-Flom Center

11:05 – 11:20am: Break

11:20 – 12:20pm: Panel 7: Major Issues in Device Regulation

• Jeffrey Shapiro, Hyman, Phelps, McNamara PC – Why the 510(k) Pathway is the Right Approach for Most Medical Devices
• Kayte Spector-Bagdady/Elizabeth Pike, Presidential Commission for the Study of Bioethical Issues – Device-ive Maneuvers: FDA Regulation of the Bifurcation of Direct-to-Consumer Genomic Data and Information
• Thomas R. McLean, American Medical Litigation Support Services/ Alexander McLean, University of Texas at Austin School of Law – Post-Market Surveillance of Medical Devices
• Moderator: W. Nicholson Price II, Petrie-Flom Center

12:20 – 12:35pm: Break

12:35 – 1:20pm: Lunch and Plenary 3

• Susan Winckler, President and CEO, Food & Drug Law Institute

1:20 – 1:30pm: Break

1:30-2:45pm: Panel 8: Major Issues in Food, Supplement, and Tobacco Regulation

• Robin Craig, Leslie Francis, Erika George, S.J. Quinney College of Law, University of Utah – The FDA’s Authority Over Labeling: Current Ironies and Future Improvements
• Jennifer Pomeranz, Yale Rudd Center for Food Policy & Obesity – Food Labeling and Enforcement
• Diana Winters, Indiana University Robert H. McKinney School of Law – From Industrial to Artisanal: Food Regulation and the Problem of Scale
• Joanna Sax, California Western School of Law – The Tobacco Diaries: Lessons Learned and Applied to Regulation of Dietary Supplements
• Moderator: Emily Broad Leib, Harvard Law School

2:45-3:45pm: Panel 9: Addressing the Challenges of and Harnessing New Technologies

• Margaret Riley, University of Virginia School of Law – FDA’s Authority to Regulate Regenerative Technology
• Nathan Cortez, Southern Methodist University Dedman School of Law – Is the FDA Equipped to Regulate Mobile Health Devices?
• David Rosenberg, Andrew English, Huaou Yan, Harvard Law School – Enhancing FDA Oversight of Medical Product Usage: A New Regulatory Role for e-Prescriptions
• Moderator: Frances Miller, Boston University School of Law

Closing Remarks, 3:45-4:00

• I. Glenn Cohen, Executive Director, Petrie-Flom Center