The Food and Drug Administration in the 21st Century

This is a past event

The 2013 Petrie-Flom Center Annual Conference

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

9:15 – 10:00am: Plenary 1

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

11:00 – 11:15am: Break

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

12:30 – 12:45pm: Break

12:45 – 1:30pm: Lunch and Keynote

1:30-1:45pm: Break

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

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

3:30 – 3:45pm: Break

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

Saturday, May 4, 2013

9:00 – 9:05am: Welcome

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

11:05 – 11:20am: Break

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

12:20 – 12:35pm: Break

12:35 – 1:20pm: Lunch and Plenary 3

1:20 – 1:30pm: Break

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

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

Closing Remarks, 3:45-4:00