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.

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Non-Profit

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Government

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Academic

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Student

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Agenda

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 

12:10–1:25 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 Vonshay Sharpe, President, Women’s Institute for Science, Equity, and Race
Moderator:  Lewis A. Grossman, Professor of Law and Affiliate Professor of History, American University, Washington College of Law

1:25 – 1:35 PM
Break

1:35–2:35 PM
Commentary Discussion

“Incentivizing Racial Diversity in Clinical Trials with Expedited Programs”

AuthorsSarah Thompson Schick, Associate, DLA Piper LLC & Kirsten Axelsen, Senior Policy Advisor, DLA Piper LLC 
Discussant: Jill A. Fisher, Professor of Social Medicine, University of North Carolina, Chapel Hill
Moderator: Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP

2:35–3:50 PM
Paper Presentation and Discussion

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

AuthorMichael R. Ulrich, Assistant Professor of Health Law, Ethics & Human Rights, Boston University 
Discussant: Tammi Shimere Etheridge, Assistant Professor, Elon University School of Law
Moderator: Daniel Giovenco, Assistant Professor, Sociomedical Sciences, Columbia Mailman School of Public Health

 

 

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

12:00–1:15 PM
Paper Presentation and Discussion

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

Author: Brittany Raposa, Associate Director & Professor of Bar Support, Roger Williams University School of Law 
Discussant: Myrisha S. Lewis, Associate Professor of Law, William & Mary Law School
Moderator: Laurie Beyranevand, Director, Center for Agriculture and Food Systems and Professor of Law, Vermont Law School

1:15–1:25 PM
Break

1:25–2:30 PM
Paper Presentation and Discussion              

“Of Vaccine and Hesitancy”

Author: Jasper L. Tran, Associate, Milbank LLP
Discussant: Matiangai Sirleaf, Nathan Patz Professor of Law, University of Maryland School of Law
Moderator: Joseph A. Page, Professor Emeritus, Georgetown University Law Center

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

“Racial Equity Implications of Artificial Intelligence in Health Care”

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

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