Conferences & Symposia

Emerging Issues in Food and Drug Law: A National Conference for Lawyers, Policy-Makers, and Corporate Leaders


Monday, November 16, 2009

Keynote speakers:

Dr. Andrew C. von Eschenbach
Former Commissioner of Food and Drugs, U.S. Food and Drug Administration

Jeffrey M. Senger, Esq.
Deputy Chief Counsel, U.S. Food and Drug Administration

It is a critical time in the food and drug industry and within the U.S. Food and Drug Administration (FDA or the Agency). New regulators, policy-makers, and industry leaders are engaged in intense policy debates that will shape the face of food and drug law for decades to come. Join regulators, industry leaders, and legal experts in a day-long conference dedicated to emerging issues in food and drug law.

WATCH VIDEO

Welcome and Introduction %BB
Panel 1 %BB
Panel 2 %BB
Lunch Keynote %BB
Panel 4 %BB

PROGRAM

8:30 a.m. Registration & Continental Breakfast

9:00 a.m. Opening Remarks
Phoebe A. Haddon, JD
Dean and Professor of Law
University of Maryland School of Law


Diane E. Hoffmann, JD, MS
Associate Dean for Academic Programs,
Director, Law and Health Care Program
University of Maryland School of Law
9:15 a.m. Keynote: FDA Priorities of the Next Four Years
Jeffrey M. Senger, Esq.
Deputy Chief Counsel
U.S. Food and Drug Administration (FDA)

9:45 a.m. Panel: Preemption and the Impact of Riegel v. Medtronic and Wyeth v. Levine on Drug and Device Labeling
These two Supreme Court cases, one involving a medical device and the other a drug, have altered the landscape for the preemptive effect of medical device and drug labeling. This panel will discuss these seminal Supreme Court decisions and their impact on the preemptive effect of product labeling on state tort claims. Panelists will discuss the policy and legal implications of these decisions from a regulatory and patient perspective.

Panelists:
Sheldon Bradshaw, Esq.
Partner, Hunton & Williams
(Former FDA Chief Counsel)


Brian Wolfman, Esq.
Institute for Public Representation
Georgetown University Law Center
(formerly of Public Citizen & Counsel for respondent in Wyeth v. Levine)


Erika Leitzan, Esq.
Partner
Covington & Burling, LLC


Moderator:
Francis B. Palumbo, PhD, JD
Executive Director
University of Maryland Center for Drugs & Public Policy
11:15 a.m. Panel: A Regulatory Pathway for Follow-on Biologics
The U.S. Congress is considering creating an abbreviated approval pathway for follow-on biologics (also referred to as biosimilars or follow-on protein products). There is substantial debate among regulators and policymakers over scientific and legal issues involved in creating this approval pathway. This panel will discuss the scope of FDA's use of the 505(b)(2) approval process, the pending follow-on legislation, immunogenicity, exclusivity periods, clinical trials and other essential issues in this debate.

Panelists:
Shawn Brown
Vice President for State Government Affairs
Generic Pharmaceutical Association


John E. Calfee, PhD
Resident Scholar
American Enterprise Institute for Public Policy Research


Kay Holcomb
Genzyme Corporation

Moderator:
Jeremiah J. Kelly, Esq., MPP
Whiteford, Taylor & Preston
12:30 p.m. Lunch
Keynote Speaker, Dr. Andrew von Eschenbach
Former Commissioner, U.S. Food and Drug Administration.
1:45 p.m. Panel: Navigating FDAAA: The Challenges of Risk Evaluation & Mitigation Strategies (REMS)
REMS were a principal feature of the Food and Drug Administration Amendments Act (FDAAA) of 2007. REMS were intended to usher in a new era of drug safety and post-market drug surveillance. However, FDA's implementation of REMS and the industry's consternation about these provisions of FDAAA have caused substantial debate. This panel will discuss the regulatory progress in implementing REMS and the principal hurdles facing the industry in complying with the law. This panel will also address related provisions of FDAAA meant to enhance the effect of REMS.

Panelists:
Sheila Weiss Smith, PhD
Professor
University of Maryland School of Pharmacy


Maya Florence, Esq.
Associate
Skadden, Arps, Slate, Meagher & Flom


Gerald Masoudi, Esq.
Partner
Covington & Burling LLC
(former FDA Chief Counsel)


Moderator:
Diane E. Hoffmann, JD, MS
Associate Dean for Academic Programs,
Director, Law and Health Care Program
University of Maryland School of Law
3:15 p.m. Panel: The Future of Generic Drugs: Patents, Exclusivity, and Litigation.
Generic drugs provide a bioequivalent substitute for more expensive innovator drug products. However, the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) has been criticized for its purported weaknesses in facilitating the timely entry of generic drugs onto the market. This panel will discuss the effectiveness of Hatch-Waxman, including exclusivity, anti-trust, and patent issues.

Panelists:
Bruce Lehman, Esq.
Senior Counsel
Whiteford, Taylor & Preston
(former Commissioner of Patents & Trademarks)


Robert A. Dormer, Esq.
Partner
Hyman, Phelps & McNamara


Elizabeth H. Dickinson
Associate Chief Counsel for Drugs, Office of the Chief Counsel
U.S. Food and Drug Administration


Moderator:
Lawrence Sung, JD, PhD
Law School Professor and Director, Intellectual Property Law Program
University of Maryland School of Law
4:30 p.m. Networking Reception for Speakers & Attendees

Papers from this conference will be published in the upcoming Spring 2010 edition of the School of Law's Journal of Health Care Law & Policy.

Sponsored by the University of Maryland School of Law, Whiteford, Taylor & Preston, LLC, Greenleaf Health LLC, and The University of Maryland Center on Drugs and Public Policy.


Back To Top

UM Shuttle UM | About This Site | Site Map | Contact Us


500 W. Baltimore Street, Baltimore, MD 21201-1786 PHONE: (410) 706-7214 FAX: (410) 706-4045 / TDD: (410) 706-7714
Copyright © 2014, University of Maryland Francis King Carey School of Law. All Rights Reserved.

Hotline Hotline



UM | About This Site | Site Map | Contact Us


500 W. Baltimore Street, Baltimore, MD 21201-1786 PHONE: (410) 706-7214 FAX: (410) 706-4045 / TDD: (410) 706-7714

Copyright © 2014, University of Maryland Francis King Carey School of Law. All Rights Reserved