Annual Conference: The Food and Drug Administration in the 21st Century

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School invites you to attend our annual conference, this year entitled: “The Food and Drug Administration in the 21^st Century.” The event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts.

WITH OVER 200 REGISTERED ATTENDEES, WE'VE REACHED CAPACITY AND REGISTRATION IS NOW CLOSED.  IF WE RECEIVE ANY CANCELLATIONS, WE WILL RE-OPEN REGISTRATION. CONFERENCE VIDEO WILL BE AVAILABLE AT THE PETRIE-FLOM WEBSITE WITHIN A FEW WEEKS AFTER THE MEETING.

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 21^st 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 will  gather 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 Sessions

* For the full conference agenda, including speakers, presentation titles, and specific times, please click here. *

DAY 1 – Friday, May 3, 2013, 9:00-5:00

• Welcome and Introduction
• PLENARY 1 - PETER BARTON HUTT (Covington & Burling)
• The FDA in a Changing World
• Preserving Public Trust and Demanding Accountability
• LUNCH AND KEYNOTE - DEBORAH AUTOR (Deputy Commissioner for Global Regulatory Operations and Policy, FDA), with an introduction by JEFFREY SENGER (Sidley Austin)
• Protecting the Public Within Constitutional Limits
• Timing Is Everything: Balancing Access and Uncertainty
• Major Issues in Drug Regulation

DAY 2 – Saturday, May 4, 2013, 9:00-4:00

• Welcome
• PLENARY 2 - ALTA CHARO (University of Wisconsin Law School)
• Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
• Major Issues in Device Regulation
• LUNCH AND PLENARY 3 - SUSAN WINCKLER (President and CEO, Food & Drug Law Institute)
• Major Issues in Food, Supplement, and Tobacco Regulation
• Addressing the Challenges of and Harnessing New Technologies
• Closing Remarks

 

Register Now!