Emerging Issues in Food and Drug Law: A National Conference for Lawyers, Policy-Makers, and Corporate Leaders
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, policymakers 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.
8:30 a.m. Registration & Continental Breakfast
9 a.m. Opening Remarks
Diane E. Hoffmann, JD, MS
Associate Dean for Academic Programs,
Director, Law and Health Care Program
University of Maryland School of Law
Jeffrey M. Senger, Esq.
Deputy Chief Counsel
U.S. Food and Drug Administration (FDA)
10 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.
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.
12:30 p.m. Lunch
Keynote Speaker, Dr. Andrew von Eschenbach
Former Commissioner, U.S. Food and Drug Administration.
2 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.
3:30 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.
5 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.