Updates for 2021

FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current pandemic. With this in mind, we are excited to announce that the 2021 FDLJ Symposium will be a virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience with ample opportunities to connect with your peers. Be sure to check the symposium website regularly for additional announcements and updates.

The Food and Drug Law Institute, in collaboration with the O’Neill Institute for National and Global Health Law and the Georgetown University Law Center, is soliciting legal scholarship on topics addressing racial equity and inclusion in food and drug law, policy, and regulation. Submissions might examine causes and opportunities to overcome racial injustice or provide specific analysis of actions for building equity into food and drug law or address other topics exploring the past, present, and future of racial equity in this field. Like the Food and Drug Law Journal, this Symposium will focus on topics within the purview of the Food and Drug Administration (FDA), but submissions can address other regulators in addition to FDA.

Goals of Symposium:

  1. Identify and discuss past and present racial injustices in food and drug law
  2. Suggest and analyze possible remedies and reforms

The Food and Drug Law Journal 2021 Symposium encourages thoughtful scholarship on topics addressing racial inequities in food and drug law and regulation, such as:

  • Inequities in drug development, including diversifying clinical trial subjects
  • Effects of underrepresentation of racial minorities in regulatory decision-making on understanding of certain conditions and best treatment measures
  • Unconscious bias and its impact on medical product development
  • Drug accessibility in underserved communities
  • Effect of data collection and interpretation, including in the utilization of Real-World Evidence
  • Regulation of flavored tobacco products
  • Advertising potentially riskier food, drug, and cosmetics products to people of color
  • Inequity in regulation of cosmetics products
  • Vaccine hesitancy and lessons learned from COVID-19
  • Whether there is a need for new legal authorities or regulations, and what those could be

Call for Submissions

The Call for Submissions closed on June 28, 2021. Draft articles must be submitted by October 18. Thank you to everyone who submitted a paper!

Please contact Paige Samson with any questions.

Paper Submissions:

The Food and Drug Law Journal (FDLJ) is the publication sponsor for this Symposium and reserves a right of first refusal to publish accepted papers, subject to the editorial review process. All final papers should be under 25,000 words in length, double-spaced, and in Times New Roman font. FDLJ requires footnotes that conform with the 21st edition of The Bluebook: A Uniform System of Citation. Additional author guidelines are available here. Questions regarding submission requirements may be directed to [email protected].

Commentary Submissions:

Commentaries are complementary discussion pieces and should be written to foster dialogue on a particular subject. Final commentaries should be no more than 6,000 words, in a more informal style with sparing use of citations.

Register Now

Industry & Firms

FREE
  • $199 for nonmembers

Non-Profit

FREE
  • $49 for nonmembers

Government

FREE
  • $49 for nonmembers

Academic

FREE
  • $49 for nonmembers

Student

FREE
Register Now

Agenda

subject to change
All times are in Eastern Time

 

Thursday, November 4

11:30–11:40 AM
Welcome and Announcements
Amy Comstock Rick, President & CEO, FDLI
Paige Samson, Director, Innovative Programs and Publications, FDLI

11:40 AM–12:10 PM
Keynote Address
Danielle Holley-Walker, Dean, Howard University School of Law
Introduced by: Daniel A. Kracov, Partner, Arnold & Porter and Chair, FDLI Board of Directors 

12:10–12:55 PM
Paper Presentation and Discussion

“Eugenics and the Development of U.S. Food and Drug Law”

Author: Daniel A. Kracov, Partner, Arnold & Porter and Chair, FDLI Board of Directors
Discussant:  Rhonda V. Sharpe, President, Women’s Institute for Science, Equity, and Race
Moderator:  Lewis Grossman, Professor of Law and Affiliate Professor of History, American University, Washington College of Law

12:55 – 1:25 PM
Audience Discussion and Q&A

1:25 – 1:35 PM
Break

1:35–2:35 PM
Commentary Discussion and Audience Q&A

“Incentivizing Racial Diversity in Clinical Trials with Expedited Programs”

Authors: Sarah Schick & Kirsten Axelsen, DLA Piper

Discussant: Jill A. Fisher, Professor of Social Medicine, University of North Carolina, Chapel Hill

2:35–3:20 PM
Paper Presentation and Discussion

“E-Racing Health Disparities: Menthol, E-Cigarettes, and Continued Efforts to Target People of Color”

Author: Michael Ulrich, Boston University
Discussant: Tammi Shimere Etheridge, Assistant Professor, Elon University School of Law

3:20–3:50 PM
Audience Discussion & Q&A

Friday, November 5

11:30–11:40 AM
Welcome and Announcements
Paige Samson, Director, Innovative Programs and Publications, FDLI
Sonia L. Canzater, Associate Director, Hepatitis Policy Project, O’Neill Institute for National and Global Health Law, Georgetown University Law Center

11:40 AM–12:00 PM
Keynote Address
RADM Richardae Araojo, Associate Commissioner for Minority Health, Office of Minority Health and Health Equity (OMHHE), FDA
Introduced by: Marie Boyd, Associate Professor of Law, University of South Carolina School of Law and Chair, Food and Drug Law Journal Editorial Advisory Board

12:00–12:45 PM
Paper Presentation and Discussion

“The War on Abortion Drugs: Unequal Access to Medical Abortion”

Author: Brittany Raposa, Roger Williams School of Law
Discussant: Myrisha S. Lewis, Associate Professor of Law, William & Mary Law School

12:45–1:15 PM
Audience Discussion and Q&A

1:15–1:25 PM
Break

1:25–2:10 PM
Paper Presentation and Discussion              

“Of Vaccine and Hesitancy”

Author: Jasper Tran, Milbank LLP
Discussant: Matiangai Sirleaf, Nathan Patz Professor of Law, University of Maryland School of Law

2:10–2:30 PM
Audience Discussion and Q&A

2:40–3:40 PM
Commentary Discussion and Audience Q&A

“Bias Concerns in the Development and Implementation of Artificial Intelligence and Machine Learning”

Author: Patrick Ross, The Joint Commission
Discussant: Pilar Ossorio, Professor of Law and Bioethics, University of Wisconsin-Madison Law School

3:40 PM
Symposium Adjournment

 

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

 

Planning Committee

Elizabeth H. Anderson, Anderson & Associates, LLC
Richardae Araojo, FDA – OMHHE
Oluwaseun (Kemi) Asante, FDA – CDER
Laurie Beyranevand, Vermont Law School
Marie Boyd, University of South Carolina, and Chair, Food and Drug Law Journal Editorial Advisory Board
Christine P. Bump, Penn Avenue Law & Policy
Sonia Canzater, O’Neill Institute for National & Global Health Law
Jonathan M. Cohen, K&L Gates LLP
Bridget C. E. Dooling, George Washington University
Lewis A. Grossman, American University
John Johnson, Shook, Hardy & Bacon LLP
Sara Wexler Koblitz, Hyman, Phelps & McNamara, PC
Daniel A. Kracov, Arnold & Porter LLP, and Chair, FDLI Board of Directors
Marian J. Lee, Gibson Dunn & Crutcher LLP
Priya Mannan, Novartis Pharmaceuticals Corporation
Valerie B. Marshall, FDA – CBER
Cynthia L. Meyer, Kleinfeld, Kaplan & Becker, LLP
Alan Minsk, Arnall Golden Gregory LLP
James O’Reilly, University of Cincinnati
Joseph Page (Academic Advisor), Georgetown University
Jessica Ringel, King & Spalding LLP
Daniel Orr, Thomson Reuters
Tyler Scandalios, Greenberg Traurig, LLP
Shy Shorer, National Institutes of Health
Genevieve Spires, Buchanan Ingersoll & Rooney PC
Twyla Thompson, FDA – OMHHE
John Warnke, Georgetown University