Day 1- April 23 7:00 – 8:15 a.m. (Amphitheater Foyer)
Registration and Continental Breakfast
8:15 – 9:00 a.m. (Amphitheater)
Susan C. Winckler, RPh, President & CEO, FDLI
Elizabeth H. Anderson, Executive Vice President-Legal and General Counsel, Personal Care Products Council and Chair, FDLI Board
Margaret A. Hamburg, MD, Commissioner of Food and Drugs
Introduced by Elizabeth H. Anderson
9:00 – 10:00 a.m. (Amphitheater)
Plenary Session: Update on FDA’s Global Strategy
Hear directly from top FDA officials about the agency’s latest international activities, including:
- Global goals and priorities for 2013;
- Developments in mutual recognition of foreign regulatory authorities and the use of foreign agency inspection outcomes;
- Updates on real-world challenges and successes of monitoring foreign manufacturers; and
- Efforts to ensure a comparable level of interaction and support of domestic manufacturers.
Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy
Sema Hashemi, Director, Asia-Pacific Office
Sabine Haubenreisser, European Medicines Agency Liaison
Steven Solomon, DVM, Acting Deputy Associate Commissioner for Regulatory Affairs
Mary Lou Valdez, Associate Commissioner, Office of International Programs
Moderated by Geoffrey M. Levitt, Senior Vice President and Associate General Counsel for Regulatory and Policy Law, Pfizer, Inc. and Immediate Past Chair, FDLI Board
10:00 – 10:30 a.m. (Amphitheater Foyer)
10:30 – 12:00 p.m. (Amphitheater) Plenary Session: Practical Impact of Caronia and First Amendment Implications
The recent landmark decision in US v. Caronia builds on a line of First Amendment cases, including IMS Health Inc. v. Sorrell, which question the foundation of prosecuting off-label promotions in all areas of food and drug law. The Caronia decision raises the issue of prosecutorial discretion and suggests that drug, medical device, food, cosmetic and tobacco stakeholders may have a First Amendment defense to a wide range of Federal Food, Drug and Cosmetic Act requirements. In this session, you'll learn how these cases will be practically applied in defending future prosecutions. In this session, you'll hear from experts in each FDA-regulated industry sector how these cases will be practically applied in defending future prosecutions. This panel will also address whether marketing and sales personnel should behave differently in light of Caronia.
David Chadwick, PhD, RAC, FRAPS, Director Regulatory Affairs, Regulatory Science, Cook Medical
Fred Degnan, Partner, King and Spalding
Jeffrey Francer, Assistant General Counsel, PhRMA
Ralph Hall, Professor, University of Minnesota
Ilana M. Knopf, Director, Center for Public Health and Tobacco Policy, New England School of Law
Richard A. Samp, Chief Counsel, Washington Legal Foundation
Marc Scheineson, Partner, Alston & Bird LLP
Moderated by Frederick R. Ball, Partner, Duane Morris LLP
12:00 – 12:25 p.m. (Amphitheater)
FDA Alumni Association Award Presentation
A lectureship named in honor of Dr. Harvey W. Wiley, the renowned physician-chemist who, at the turn of the 20th century, championed a legislative crusade against food adulteration, earning him the title of “Father of the Pure Food and Drugs Act” when it was enacted into law in 1906.
The 2013 Wiley Award Winner is Richard M. Cooper, Of Counsel at Williams & Connolly LLP. Richard Cooper is a litigator. Identified as one of "Washington's Top Lawyers" for Food and Drug law by Washingtonian magazine (December 2011) and one of the "Best FDA Lawyers" (2012), his principal area of practice is food and drug law, particularly relating to medical products, and including advising, and enforcement. He was lead counsel in a commercial arbitration that, in 2007, resulted in an award of more than $395 million for his client. Other recent and current matters include litigation over a product-related decision by FDA, defense against a claim of false advertising, defense against claims of improper pharmaceutical pricing, and resolution of FDA enforcement actions. As lead counsel, he argued successfully in FDA v. Brown & Williamson Tobacco Corp., 529 US 120 (2000). He has represented clients in congressional and other hearings. His clients have included major pharmaceutical and other consumer products companies. Mr. Cooper has taught food and drug law at Georgetown University Law Center (1987-92, 1996), has written extensively in the field, and has served on numerous committees.
12:30 – 1:50 p.m. (Atrium Ballroom)
Melinda Plaisier, Acting Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, Global Regulatory Operations and Policy
Introduced by Philip Katz, Partner, Hogan Lovells and Vice Chair, FDLI Board
2:00 – 3:30 p.m.
Concurrent Breakouts: FDA Center Directors
Representatives from FDA’s product Centers will discuss the three most important developments from last year and their three most important goals in 2013. You’ll hear directly from Center representatives, as well as food and drug law stakeholders responding to their presentations.
Center for Food Safety and Applied Nutrition (CFSAN) (Hemisphere B)
Michael M. Landa, Director, Center for Food Safety and Applied Nutrition
Steven Armstrong, Senior Food Law Counsel, Campbell Soup Company
Daniel L. Engeljohn, Ph.D., Assistant Administrator, Office of Field Operations, Food Safety and Inspection Service, USDA
Leslie T. Krasny, Partner, Keller and Heckman LLP and Member, FDLI Board
Patty Lovera, Assistant Director, Food & Water Watch
Gina Nicholson, Global Client Director of Retail Food Services, NSF International
Moderated by Erica Battaglia, Divisional Vice President & Associate General Counsel, Legal Regulatory & Compliance, Abbott Laboratories
Center for Veterinary Medicine (CVM) (Oceanic B)
, Deputy Director, Center for Veterinary Medicine Jennifer Spokes Johansson
, Senior Vice President, Regulatory Policy & Counsel, Putney, Inc. and Vice Chair, Generic Animal Drug Alliance Stephen Sundlof, DVM, PhD
, Senior Advisor, EAS Consulting Group
Moderated by Sheldon Bradshaw
, Partner and Co-chair, Food and Drug Practice, Hunton & Williams LLP
Center for Biologics Evaluation and Research (CBER) (Polaris A)
Diane Maloney, Esq.,
Associate Director for Policy, Center for Biologics Evaluation and Research Mary Malarkey,
Director, Office of Compliance and Biologics Quality Brian Malkin,
Partner, Frommer, Lawrence & Haug LLP
Michael S. Reilly, Executive Director, Alliance for Safe Biologic Medicines Moderated by Scott Cunningham,
Mark S. Robbins, PhD, VP, Clinical Regulatory Affairs, DiaMedica USA, Inc.
Partner, Covington & Burling LLP
Center for Devices and Radiological Health (CDRH) (Polaris BC)
Jeffrey Shuren, MD, Director, Center for Devices and Radiological Health
Kate Ryan, Senior Program Coordinator, National Women's Health Network
Judith K. Meritz, Associate General Counsel, Covidien
Sandra C. Kalter, Vice President, Chief Regulatory Counsel, Medtronic
John R. Manthei, Partner, Latham & Watkins
Moderated by Jennifer L. Bragg, Partner, Skadden, Arps, Slater, Meagher & Flom, LLP
Center for Drug Evaluation and Research (CDER) (Amphitheater)
Janet Woodcock, MD, Director, Center for Drug Evaluation and Research
Sara Zborovski, Partner, Gilbert's LLP
Eric Gascho, Director, Government Affairs, National Health Council
Virginia G. Beakes-Read, Executive Director, Global Regulatory Policy and Intelligence, Global Regulatory Affairs, Eisai, Inc.
Mark C. Levy, Partner, Eckert Seamans Cherin & Mellott, LLC
Moderated by Joseph L. Fink, Professor, Pharmacy Law & Policy, University of Kentucky College of Pharmacy
Harm Reduction and Innovation: Update on FDA’s Regulation of NRTs and Smoking-Cessation Products (Hemisphere A)
This session follows up on issues raised during FDA’s December public hearing on agency actions related to nicotine replacement therapies (NRTs) and smoking-cessation products, including modified risk tobacco products (MRTPs). Panelists will provide regulatory updates and discuss concerning the implementation of section 918 of the FDCA, including approval mechanisms, additional indications, and extended use of NRTs and related products that deliver nicotine. The panel will also consider the report to Congress (pending its delivery in March 2013) on the development of innovative products and treatments for tobacco dependence.
Grail Sipes, Senior Regulatory Counsel, Office of Regulatory Policy, CDER, FDA
Jonathan Foulds, Phd, Professor of Public Health Sciences & Psychiatric, Penn State University, College of Medicine, Cancer Institute, Cancer Control Program
Jed E. Rose, PhD, Director, Center for Smoking Cessation and Professor, Department of Psychiatry and Behavioral Science, Duke University Medical Center
Jeffrey P. Walker, MD, Vice President and Chief Medical Officer, Altria Client Services
Moderated by Carlos Angulo, Partner, Zuckerman Spaeder LLP
3:30 – 4:00 p.m.
Networking Break (Amphitheater Foyer)
4:00 – 5:30 p.m.
Concurrent Breakouts: Compliance and Liability Issues
- Drugs/Biologics: REMS and FDA Regulation: Opportunities and Challenges (Amphitheater)
With the recent release of a report by the Office of the Inspector General at the Department of Health and Human Services calling into question the effectiveness of one of FDA’s key strategies for managing drug risks — the Risk Evaluation and Mitigation Strategies (REMS) — this panel will address the challenges and opportunities the agency has faced in their implementation from 2007 through today. REMS impact every aspect of development and commercialization of drugs. The session will also discuss how manufacturers should address the practical implications of FDA’s statutory authority, manufacturers’ responsibilities and examination of core functions relating to regulation, liability and compliance.
Barri Falk, Director, Life Sciences & Healthcare Strategy, Deloitte Consulting LLP
Karen Gerlach, PhD, MPH, Co-Director, Clinical and Behavioral Research, Pinney Associates
Paul Kim, Partner, Foley Hoag LLP
Barbara A. Binzak Blumenfeld, PhD, Counsel, Buchanan Ingersoll & Rooney PC and Member, FDLI Board
Moderated by Howard L. Dorfman, Vice President and General Counsel, Ferring Pharmaceuticals Inc.
- Medical Devices: Latest Enforcement Developments (Polaris BC)
Medical device stakeholders should be aware of the array of enforcement tools CDRH uses to hold companies accountable, including injunctions, recalls and warning letters. To avoid liability, medical device manufacturers must understand how to comply with the requirements of clinical trials, current good manufacturing practices (cGMPs), and quality system regulations (QSRs). This session will provide practical advice on how companies can avoid and respond to enforcement actions.
Michele L. Buenafe, Associate, Morgan, Lewis & Bockius LLP
Glenn Mattei, Director of Global Compliance, Bausch & Lomb, Inc.
Philip, J. Phillips, President, Phillips Consulting Group, LLC
Gael Tisack, Vice President of Legal Affairs, Terumo Cardiovascular Systems
Moderated by Joy J. Liu, Partner, Ropes & Gray LLP
- Dietary Supplements/Cosmetics/Food: Nanotechnology at a Crossroads (Polaris A)
Nanotechnology is increasingly utilized to manufacture products in almost every industry sector regulated by FDA, including food, dietary supplements and cosmetics. This session will assess the scientific knowledge about nanotechnology’s health and environmental impact; and current regulation of nanotechnology as it affects food, dietary supplement and cosmetic manufacturers.
Ritu Nalubola, PhD, Senior Policy Advisor, Office of Policy, Office of the Commissioner, FDA
Jay Ansell, Vice President, Cosmetics Program, Personal Care Products Council
Raj Bawa, PhD, Patent Agent, Bawa Biotech LLC and Adjunct Professor, Rensselaer Polytechnic
Adam Soliman, Agriculture and Food Law (Candidate), Faculty of Law, University of Arkansas
Moderated by Ricardo Carvajal, Director, Hyman, Phelps & McNamara P.C.
- Food: Case Study of the Sunland Peanut Butter Recall (Hemisphere B)
A Case Study of the 2009 Peanut Corporation of American Peanut Butter Recall and 2012 Sunland Peanut Butter Recall Since the enactment of FSMA, FDA and industry have continued to grapple with food safety recalls, peanut-containing products have been recalled both pre- and post-FSMA enactment, with considerably different approaches. This session will look at how the FDA approached both recalls, as well as how the public and the media reacted to each situation.
In this panel you will learn:
- Food safety recall processes both pre and post FSMA, looking at recalls from both a reactive and preventative approach,
- Brief overview of media coverage of both the 2009 and 2012 recalls, and
- Newly enacted powers of FDA based on the passage of FSMA.
Roberta Wagner, Director, Office of Compliance, Center for Food Safety and Applied Nutrition, FDA
Sarah L. Brew, Partner, Faegre Baker Daniels LLP
Gale Prince, Founder and President, SAGE Food Safety, LLC
Moderated by Sonali P. Gunawardhana, Of Counsel, FDA Practice Group, Wiley Rein LLP
- Veterinary Medicine/Animal Drugs: Two Important Issues - Antimicrobial Resistance & the Jerky Treat Investigation (Oceanic B)
The National Antimicrobial Resistance Monitoring System (NARMS) reported a slight increase in animal antibiotics and an increase in certain types of drug resistance among bacteria found on meat and ground poultry products. This panel will address the overuse of antibiotics in our food supply and discuss what FDA, USDA and companies are doing to take action. In 2012, stories on chicken jerky pet treats made in China had pet owners and veterinarians questioning if dogs were becoming sick and dying after eating chicken jerky treats for pets. This panel will consider that FDA’s efforts to determine if Chinese production of these treats is a factor and the effect this is having on retailers and pet-food companies who import these treats.
Tracey Forfa, Deputy Director, Center for Veterinary Medicine
Sarah Borron, Researcher, Food and Water Watch
Sarah Klein, Senior Staff Attorney, Food Safety Program, Center for Science in Public Interest
Moderated by Meghan F. Davis, DVM, PhD, Postdoctoral Fellow, Department of Environmental Health, Johns Hopkins Bloomberg School of Public Health
- Tobacco Product Deeming Regulations - Are They Appropriate and What Should They Look Like? (Hemisphere A)
FDA has indicated that it will publish proposed deeming regulations this spring to expand its tobacco product jurisdiction to additional tobacco products, such as cigars, pipe tobacco and electronic cigarettes. This session will address issues related to the implementation of such regulations. Panelists will cover a range of topics, including new tobacco product requirements, allocation of user fees to new tobacco categories, an appropriate grandfather date for newly-regulated tobacco products, advertising regulations and marketing restrictions, and good manufacturing practices.
Bryan M. Haynes, Partner, Troutman Sanders LLP
Bill Godshall, Executive Director, Smokefree Pennsylvania
Rebecca Maisel, Vice President and General Councel, FIN Branding Group, LLC
Daniel P. McGee, General Counsel, General Cigar Co., Inc.
Moderated by Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP
5:30 – 6:30 p.m. (Amphitheater Foyer)
Day 2- April 24
7:30 – 8:30 a.m. (Amphitheater Foyer)
Registration and Continental Breakfast
8:30 – 10:00 a.m. (Amphitheater)
Top 20 Cases in Food and Drug Law in 2012 and Cases to Watch in 2013
Drawing from FDLI’s 2013 edition of Top 20 Cases, food and drug law professors will discuss the legal and practical impact—on the entire food and drug law community— of four of 2012’s most sweeping cases and highlight cases to watch in 2013:
William M. Janssen, Associate Professor of Law, Charleston School of Law
Weddle v. Bayer AG Corporation
Allison Zieve, Director, Public Citizen Litigation Group
Bartlett v. Mutual Pharmaceutical
Margaret Foster Riley, Professor, University of Virginia School of Law
United States v. Regenerative Sciences, LLC, et al.
Lisa Heinzerling, Professor of Law, Georgetown University
Pom Wonderful LLC v. The Coca Cola Company
Moderated by John B. Reiss, PhD, Partner, Saul Ewing LLP
10:00 – 10:30 a.m. (Amphitheater Foyer)
10:30 – 12:00 p.m.
Concurrent Breakouts: Emerging Issues Ethics (CLE): Complying with the FCPA- An Exploration of Ethical Issues Raised by Recent Cases (Oceanic B)
This session will help legal and compliance professionals ensure they are up-to-date on FCPA provisions and the lessons learned from recent high-profile cases. Discussion points to include:
- When is an FCPA investigation necessary?
- The risks and benefits of self-reporting
- An overview of recent government enforcement actions
- Take-aways from recent FCPA and anti-corruption cases
Phillip S. Brewster, Partner, Brewster Law Firm LLC
Moderated by Jessica Tillipman
Patrick J. O'Toole, Jr., Partner, Complex Commercial Litigation and White Collar Defense & Investigations Groups, Weil, Gotshal & Manges LLP
Roseann Termini, Professor, Widener University School of Law
, Assistant Dean for Field Placement; Professorial Lecturer in Law, George Washington University Law School Working in the Food and Drug Law Space: Challenges and Opportunities (Polaris A)
The opportunities for employment in the food and drug law, regulation and policy space are expanding exponentially. Hear from FDA officials, private sector attorneys, manufacturers and consultants on the challenges and possibilities presented in this field.
Minnie Baylor-Henry, Worldwide Vice President-Regulatory Affairs, Medical Devices & Diagnostics, Johnson & Johnson
Jordan Paradise, Associate Professor of Law, Seton Hall University School of Law
Sheila Walcoff, Founding Principal, Goldbug Strategies LLC
Ann Wion, PhD, Deputy Chief Counsel Program Review, Office of Chief Counsel, FDA
Moderated by Michael Levin-Epstein, Senior Vice President, Product Development and Editor-in-Chief, FDLI
Tobacco: FDA Center Director Presentation (Amphitheater)
The Center Director will discuss the three most important developments from last year and the three most important goals in 2013.
Mitchell R. Zeller, J.D., Director, Center for Tobacco Products, FDA
Alfred Kevin Altman, Consultant, Council of Independent Tobacco Manufacturers of America
Mark Greenwold, Senior Consultant, Campaign for Tobacco Free Kids
James E. Swauger, Vice President, Regulatory Oversight. R.J. Reynolds Tobacco Company
Moderated by Coleen Klasmeier, Partner, Sidley Austin LLP
Drugs: Exclusivity under Challenge (Hemisphere A)
FDA's period of drug exclusivity is well-established to provide limited protection to new drugs from competition in the marketplace. However, an increasing number of companies are challenging this exclusivity period for products such as orphan drugs, antibiotics and new chemical entities. This tide of litigation is leading to policy questions about exclusivity and uncertainty about the future of FDA's exclusivity policies.
Diane E. Dorman, Vice President for Public Policy, National Organization for Rare Disorders
John J. Doyle, DPH, Senior Vice President and Managing Director, Quintiles Consulting
Chad A. Landmon, Partner, Axinn Veltrop Harkrider LLP
J. Michael Nicholas, PhD, Senior Director, Life Cycle Initiatives, Teva Pharmaceuticals
Moderated by Kurt R. Karst, Director, Hyman Phelps & McNamara, P.C.
Medical Devices: Practical Impact of Regulating New Technology (Polaris BC)
Does it seem like the regulation of medical devices isn’t keeping up with the technology? This panel will address several groundbreaking developments in the medical device world, including: a system of unique device identification (UDI); classification and regulation of mobile medical device applications; and the international Medical Device Single Audit Program, which will create one uniform system of auditing medical device manufacturers.
Kimberly A. Trautman, Associate Director for International Affairs, Office of Center Director, Center for Devices and Radiological Health, FDA
Michael M. Gaba, Partner, Holland & Knight LLP
Alan S. Goldberg, Adjunct Professor of Health Law, George Mason University, American University Washington College of Law
Moderated by Mary C. Getz, PhD, Director of Quality Systems, Medical Device Practice, Becker & Associates Consulting Inc.
Foods: What Do New Proposed Food Safety Rules Mean for Food Stakeholders? (Hemisphere B)
This panel will discuss the legal, regulatory and practical implications of the two extensive sets of proposed rules (preventive controls and produce safety) issued by FDA in January and any subsequent FSMA-mandated proposed regulations
Sandra Eskin, Director, Food Safety Campaign, The Pew Charitable Trusts
Daniel Lafontaine, DVM, Associate, HACCP Consulting Group, LLC
Erik Lieberman, Regulatory Counsel, Food Marketing Institute
Pete Tamborski, General Counsel, Sugar Creek Packing Company
Moderated by Joseph Levitt, Partner, Hogan Lovells, LLP
12:00 – 1:30 p.m. (Atrium Ballroom)
1:30 – 2:00 p.m. (Amphitheater)
Address from the Office of Chief Counsel, FDA
Elizabeth Dickinson, Chief Counsel, FDA
Introduced by Desiree Ralls-Morrison, General Counsel, Consumer Group, Johnson & Johnson and Member, FDLI Board
2:00- 3:00 p.m. (Amphitheater)
Plenary session: Interagency Dynamics - Beyond FDA
This panel will provide a unique, first-hand perspective from current and former top government officials from HHS, DOJ, USDA and FTC on how they work across agencies to communicate, collaborate and make decisions. Among issues for discussion:
William B. Schultz,
- Prosecutorial discretion;
- Budgetary considerations
- Political and turf considerations
- Dealing with the media
- Effective cooperation and collaboration
Acting General Counsel, US Department of Health and Human Services Christine DeLorme,
Acting Assistant Director of the Division of Advertising Practices, FTC Deborah Chasan-Sloan,
Attorney, Department of Health & Human Services, Office of the General Counsel, Centers for Medicare & Medicaid Services Division Beth Johnson, MS, RD
, Principal & Founder, Food Directions LLC Eugene M. Thirolf,
Moderated by Nancy Bradish Myers, President, Catalyst Healthcare Consulting
3:00– 4:15 p.m. (Amphitheater)
Plenary Session: Role of the Media in Food and Drug Law, Regulation & Policy
The deluge of media (whether official news media outlets or social media buzz) has changed the dynamics of the food and drug marketplace—increasing the influence of this important stakeholder. This session will present case studies in which the media, including social media, played critical roles in the food and drug world, including the so-called ‘pink slime’ situation, the multistate outbreak of fungal meningitis from compounded medications, and others. The panel will include media experts, including reporters and public relations professionals.
Virginia A. Cox, Associate Commissioner for External Affairs, FDA
Thomas M. Burton, Staff Reporter, The Wall Street Journal
Rachel Henderson, Vice President, Corporate & Public Affairs, Ogilvy Washington
Peter Pitts, President, Center for Medicine in the Public Interest
Moderated by Susan C. Winckler, RPh, President & CEO, FDLI