Agenda (preliminary)

Below is a preliminary agenda. Due to Administration changes that are on-going, we will be posting agenda and speaker updates periodically. Please check back with us for the most current information.

Just added to the agenda: Senator Orrin G. Hatch
& Representative Henry A. Waxman

Wednesday, April 22
Go to agenda for Thursday, April 23 >

7:00 a.m.
Registration and Continental Breakfast

8:00 a.m.
FDLI Welcome
James J. Kelly, FDLI President & CEO and William B. Schultz, Chair, FDLI Board of Directors and Partner, Zuckerman Spaeder

8:30 - 10:00 a.m.
I. Major Addresses and the FDAAA Wiley Award Presentation – Plenary
Senator Orrin Hatch and Representative Henry Waxman will deliver major speeches concerning what they see as top priorities for healthcare reform and for the FDA from a legislative perspective. They will also be presented with the FDA Alumni Association’s coveted Wiley Award. During this session, FDLI will also present key addresses by top Administration officials who will each speak to the main health and healthcare related challenges facing the new Administration as seen from their respective vantage points. Included in this session will be addresses by the offices of FDA Commissioner and Chief Counsel.

Orrin G. Hatch, (R-UT), U.S. Senate
Jesse L. Goodman, MD, MPH, Acting Chief Scientist, FDA
Jeffrey M. Senger, Deputy Chief Counsel, FDA

10:00 - 10:30 a.m.
Refreshment Break

10:30 - 11:30 a.m.
II. What is Safety? - Plenary
For drugs and medical devices, “safety” is relative, not absolute, so one has to think hard about efficacy and the ratio of benefits to risks in order to reach conclusions about safety. For other kinds of products – e.g., foods regulated by FDA, meat and poultry regulated by the U.S. Department of Agriculture, consumer products regulated by the Consumer Product Safety Commission – different sets of considerations apply. All assessments of safety under federal statutes involve the application of legal standards, scientific methods, principles, and knowledge, and the exercise of judgment. What do the processes of analysis of “safety” under different federal regulatory statutes have in common? How do they differ? What can regulators and firms dealing with “safety” under one statute learn from the experience under other statutes that require “safety”?

Moderator
Richard M. Cooper, Partner, Williams & Connolly LLP

Speakers
Cheryl A. Falvey, General Counsel, Consumer Product
Safety Commission
Scott Gottlieb, MD, Fellow, American Enterprise Institute
John E. Henitz, Partner, Kelley Drye & Warren LLP
Alan M. Rulis, PhD, Senior Managing Scientist, Center for Chemical Regulation and Food Safety, Exponent, Inc.

11:30 a.m. - 12:30 p.m.
III. Major Addresses (continued)

12:30 - 2:00 p.m.
Lunch

2:00 - 3:30 p.m.
IV. Concurrent Breakout Sessions: What is Safety?
The safety topic will be dealt with in depth by panels of leading experts from industry, healthcare, FDA and the bar covering each of the four main product sectors (foods/dietary supplements/cosmetics, drugs/biologics, medical devices and veterinary medicine with a fifth session dealing with international/import safety). Session participants will be asked to suggest creative ideas and solutions which could contribute to FDA’s considerations in the issuance of future guidance’s.

Veterinary Medicine, Caucus Room
Moderator
Edward John Allera, Partner, Buchanan Ingersoll & Rooney PC

Speakers
John D. Baker, Supervisory Veterinary Medical Officer, CVM, FDA
Martine L. Hartogensis, DVM, Deputy Director, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA
Martin Tiemann, DVM, Director, Pharmacovigilance & Product Stewardship, Intervet/Schering-Plough Animal Health
Medical Devices, Ballroom A
Moderator
Judith K. Meritz, Shareholder, Baker, Donelson,
Bearman & Caldwell, PC

Speakers
Marilyn N. Flack, Director, Patient Safety Staff, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA
Steven M. Niedelman, Senior Consultant, Crowell Moring LLP
Patricia B. Shrader, Senior Vice President, Corporate Regulatory and External Affairs, BD
International/Import Safety, Ballroom B
Moderator
Gregory H. Levine, Partner, Ropes & Gray LLP

Speakers
Stefan Dayagi, President, Pajunk Medical Systems USA
David J. Horowitz, JD, Assistant Commissioner for Policy, Office of Policy and Planning, Office of the Commissioner, FDA
Murray M. Lumpkin, MD, MSc, Deputy Commissioner for International Programs, Office of the Commissioner, FDA
Robert A. Rhoades, Director, Pharmaceutical Quality Systems and Compliance Practice, Becker & Associates Consulting, Inc.
Foods, Dietary Supplements and Cosmetics, Ballroom C
Moderator
Scott Bass, Partner, Sidley Austin LLP

Speakers
David W. K. Acheson, MD, Associate Commissioner for Foods, Office of Food Protection, Office of the Commissioner, FDA
Vasilios H. Frankos, PhD, Director, Division of Dietary Supplement Programs, Office of Nutrition, Labeling & Dietary Supplements, Center for Food Safety and Applied Nutrition, FDA
Roseann B. Termini, JD, MEd, Professor, Widener University
School of Law
John P. Venardos, Vice President, Worldwide Regulatory and Government Affairs at Herbalife International of America, Inc.
Drugs and Biologics, Ballroom D
Moderator
Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius, LLP

Speakers
Gerald J. Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA
Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy,
Sanofi-Aventis
Michael A. Swit, JD, Vice President, Life Sciences,
The Weinberg Group Inc.

3:30 - 4:00 p.m.
Refreshment Break

4:00 - 5:30 p.m.
V. Concurrent Breakout Sessions: Center Directors
In individual breakout sessions, the FDA Center Directors or their designee will each present their views as to the most significant challenges facing their Center and discuss their understanding of the priorities of the new Administration.

Center for Veterinary Medicine (CVM), Caucus Room
Moderator
Robert B. Nicholas, Capital Partner, McDermott, Will & Emery

Speakers
Tracey H. Forfa, JD, Executive Director, CVM, FDA
Karl M. Norbert, Attorney, K&L Gates
Martin Tiemann, DVM, Director, Pharmacovigilance & Product Stewardship, Intervet/Schering-Plough Animal Health
Center for Devices and Radiological Health (CDRH), Ballroom A
Moderator
Jeffrey N. Gibbs, Principal, Hyman, Phelps & McNamara, P.C.

Speakers
Catherine M. Cook, Associate Director for Regulations and Policy, CDRH, FDA
Tracy Palmer Berns, Chief Regulatory Counsel, Covidien
Ralph F. Hall, Distinguished Visiting Practitioner & Professor, University of Minnesota Law School
Helen Lewis, Director, Corporate Compliance and Regulatory Affairs, Dentsply International
Stephen D. Terman, Principal, Olsson Frank Weeda Terman
Bode Matz PC
Center for Biologics Evaluation and Research (CBER), Ballroom B
Moderator
David B. Schmickel, JD, PhD, FoxKiser

Speakers
Diane M. Maloney, JD, Associate Director for Policy, CBER, FDA
Scott A. Brubaker, CTBS, Chief Policy Officer at the American Association of Tissue Banks
Glenn N. Byrd, MBA, RAC, Director, Regulatory Affairs,
MedImmune, Inc.
Kay Holcombe, Senior Policy Advisor, Genzyme Corporation
Center for for Food Safety and Applied Nutrition
(CFSAN), Ballroom C
Moderator
Christopher L. Hagenbush, Partner, Patton Boggs LLP

Speakers
Stephen F. Sundlof, DVM, PhD, Director, CFSAN, FDA
Tony Corbo, Senior Lobbyist, Food and WaterWatch
Daniel F. Shaw, Vice President and Deputy General Counsel, H.J. Heinz Company
Edward A. Steele, President, EAS Consulting Group, LLC
Center for Drug Evaluation and Research (CDER), Ballroom D
Moderator
Richard F. Kingham, Partner, Covington & Burling LLP

Speakers
Janet Woodcock, MD, Director, CDER, FDA
Craig M. Audet, Vice President, U.S. Regulatory Affairs Marketed Products, Sanofi-Aventis
Kate C. Beardsley, Partner, Buc & Beardsley
Francis B. Palumbo, PhD, Esq, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs
and Public Policy

5:30 - 7:00 p.m.
Networking Reception

6:30 - 8:00 p.m.
Women in Food & Drug Law & Regulation: Half Full: Upcoming Challenges and Opportunities in the Current Economy (Complimentary to Annual Conference registrants; $35 to attend this session and the Networking Reception).

Moderator
Jill B. Deal, Partner, Venable, LLP

Speakers
Joy A. Cavagnaro, PhD, DABT, President, Access BIO, LC
Linda A. Suydam, DPA, President, Consumer Healthcare
Products Association (CHPA)
Linda A. Willett, Partner, Sedgwick, Detert, Moran & Arnold LLP

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Thursday, April 23
Back to agenda for Wednesday, April 22 >

7:30 - 8:30 a.m.
Continental Breakfast

8:30 – 10:00 a.m.
VI. Concurrent Breakout Sessions: Hot Topics
This Session will cover topics which FDLI Members have suggested by survey as of particular interest and or challenging from a legal and regulatory perspective including:

Managing Risk in Outsourcing Clinical Research, Ballroom A
Conducting clinical trials in a down economy has accelerated the trend toward major drug and medical device companies shedding employees and fixed assets, and filling this void by contracting out the clinical research function. The trend is enormous, and unless companies outsource diligently, major obstacles in clinical trials research can develop.

Moderator
Bradley Merrill Thompson, Attorney, Epstein Becker & Green, P.C.

Speakers
Steven E. Linberg, PhD, Managing Director and Vice President, Chiesi Pharmaceuticals, Inc.
Douglas Peddicord, PhD, MA, Executive Director, Association of Clinical Research Organizations (ACRO), Managing Partner, Oldaker, Belair & Wittie LLP, President of Washington Health Strategies Group, LLC
Elaine H. Tseng, Partner, King & Spalding LLP
States' Issues and Trends in Food and Drug Law
and Regulation, Ballroom B
How are states’ law issues impacting FDA-regulated products? Some states have become increasingly active on many of the same issues that FDA and other federal agencies regulate. In this session, discuss how companies must comply with federal and state laws, and, what trends are emerging that industry needs to consider in manufacturing products.

Moderator
Jody DeFord, Attorney, Ice Miller LLP
Speakers
J. Joseph Corby, Executive Director, Association of Food and Drug Officials (AFDO)
Virginia Ludwig, Associate Director, State Health Policy,
AstraZeneca Pharmaceuticals
Karen A. Weaver, Partner, Baker & Hostetler
The Nutrition Labeling and Education Act:
Progress and Pitfalls to Inform the Future, Ballroom C
This session will consider how well the Nutrition Labeling and Education Act (NLEA) has been working in the last 20 years. The panel, consisting of government and industry representatives will weigh in on the question, Is the NLEA living up to its intention or is there a need for an update?

Moderator
Martin J. Hahn, Partner, Hogan & Hartson, LLP
Speakers
Jeffrey W. Canavan, MPA, RN, Staff Officer, Labeling and Program Delivery Division, Office of Policy and Program Development Food Safety and Inspection Service (FSIS), United States Department of Agriculture (USDA)
Melvin S. Drozen, Partner Keller and Heckman LLP
Sally L. Jones, Acting Director, Labeling and Program Delivery Division, Office of Policy and Program Development, Food Safety and Inspection Service (FSIS), United States Department of Agriculture (USDA)
Barbara O. Schneeman, PhD, Director, Office of Nutrition, Labeling and Dietary Supplements, CFSAN, FDA
Bruce A. Silverglade, Director of Legal Affairs, Center for Science in the Public Interest
Reimbursement and other Centers for Medicare
and Medicaid Services Issues, Ballroom D
This panel will discuss recent developments in litigation affecting reimbursement including litigation over the definition of Average Manufacturer Price, the First DataBank Average Wholesale Price (AWP) reporting settlement and recent state litigation in California regarding reductions in reimbursement rates. Additionally, legislative efforts concerning reimbursement, including changes in the calculation of the federal upper limit for multiple source drugs, will be addressed. The status of the AWP pricing cases pending before Judge Saris in the United States District Court for the District of Massachusetts as well as look alike state cases, will be examined. Lastly, the panel will also discuss the Administration's efforts on evaluating comparative effectiveness and how that might affect reimbursement rates.

Moderator
Frederick R. Ball, Partner, Duane Morris LLP
Speakers
Don L. Bell, II, Senior Vice President, Legal Affairs and General Counsel, National Association of Chain Drug Stores
Areta L. Kupchyk, Partner, Reed Smith LLP

10:00 - 10:30 a.m.
Refreshment Break

10:30 a.m. - 12 Noon
VII. Concurrent Breakout Sessions: Hot Topics
This Session will cover topics which FDLI Members have suggested by survey as of particular interest and or challenging from a legal and regulatory perspective including:

Regulation of Genetically Engineered Animals, Caucus Room
Following a lengthy examination of the legal, regulatory, safety and public policy ramifications, in January 2009, the Center for Veterinary Medicine (CVM) published its final guidance for industry on the regulation of genetically-engineered (GE) animals. A few weeks later, in February 2009, FDA issued the first approval of a recombinant DNA (rDNA) construct that had been placed in a GE animal. The animal was a goat that can produce in its milk a simultaneously-approved biological product for humans. CVM is regulating these gene constructs as new animal drugs because it has concluded that under the Federal Food, Drug, and Cosmetic Act, an rDNA construct in a GE animal that is intended to affect the animal's structure or function meets the definition of a new animal drug, whether the animal is intended for food or used to produce another substance. The Center will, however, exercise regulatory discretion for some of these animals, as it has with respect to GloFish, the first GE animal sold in the U.S.

Moderator
Jeannie M. Perron, DVM, Of Counsel, Covington & Burling LLP

Speakers
Alan R. Blake, Chief Executive Officer, Yorktown Technologies, L.P.
Laura R. Epstein, Attorney, Office of the Chief Counsel, FDA
Barbara P. Glenn, PhD, Managing Director, Animal Biotechnology, Biotechnology Industry Organization (BIO)
Larisa Rudenko, PhD, Senior Advisor for Biotechnology, Office of New Animal Drug Evaluation, CVM, FDA
Richard A. Scotland, Senior Vice President, Regulatory Affairs, GTC Biotherapeutics, Inc.
Consulting Agreements with Physicians and Financial Disclosures for Clinical Investigators, Ballroom A
Recent activity and changing expectations in financial disclosure requirements have arisen when companies and physicians engage in clinical investigations. In this session, discuss what the law, FDA regulated clinical studies and PHS funded clinical studies, requires concerning financial disclosures and consulting agreements between companies and physicians who are involved in clinical investigations. What does the 2003 OIG Guidance relate about financial disclosure? What impact will the 2009 Physician Payments Sunshine Act have on industry/physician relations and conflict of interest concerns?

Moderator
Susan Alpert, PhD, MD, Senior Vice President, Chief Regulatory Officer, Medtronic, Inc.

Speakers
Ivy S. Baer, JD, MPH, Director and Regulatory Counsel, Health Care Affairs, Association of American Medical Colleges
Edward M. Basile, Senior Partner, King & Spalding, LLP
Virginia A. Gibson, Assistant U.S. Attorney & Chief, Civil Division, Eastern District of Pennsylvania, United States Attorney's Office
John B. Reiss, PhD, Partner & Chairman of Health Law Department, Saul Ewing LLP
FDA Enforcement: As it Was and Could Become, Ballroom B
Under the new Administration, what enforcement tools will operators of less ethical FDA-regulated companies likely face? Will FDA impose more debarments, more civil penalties, withdrawals, REMS and the use of additional statutory tools? How will consumers benefit from these enforcement measures?

Moderator
James T. O'Reilly, Professor, University of Cincinnati and Counsel, Baker & Daniels

Speakers
Deborah M. Autor, JD, Director, Office of Compliance, CDER, FDA
Dorothy J. Clarke, JD, RAC, Vice President, Regulatory Affairs, Office of Compliance for the Medical Devices & Diagnostics Businesses, Johnson & Johnson
Marc J. Scheineson, Partner, Alston & Bird LLP
Robert M. Spiller, Jr., former FDA Attorney (1971-2003)
Substantial Equivalence: An Aging Regulatory Construct, Ballroom D
The concept of substantial equivalence has been the foundation for U.S. device regulation for over 30 years and yet is often misunderstood leading to unfair criticism of FDA. While a recently released GAO report appropriately criticized an aspect of the 510(k) program, the report is also being cited as evidence of a need for change. This program will review the intent of Section 510(k) and the basis for substantial equivalence determinations, present criticisms of the program, and discuss the challenges in administering the 510(k) program today.

Moderator
Phillip J. Phillips, Director, Medical Device Practice, Becker & Associates Consulting, Inc.

Speakers
Catherine M. Cook, Associate Director for Regulations and Policy, CDRH, FDA
Mark A. Heller, Partner, Goodwin Procter LLP
Diana Zuckerman, PhD, President, National Research Center for Women & Families
Food Advertising – Campaigns and Claims, Ballroom C
In 2008, there were some very notable advertising battles focused on food ingredients. For example, there were the "soup wars," between Campbell's and Progresso over MSG. There were the "yogurt wars," where Dannon took General Mills to task for probiotic claims in yogurt. Further, there were the “chicken wars” between Perdue and Tyson, as well supplement fight swirling around "5 Hour Energy," and the "pomegranate battles" over purity of pomegranate juice. The panel would review the past years' battles and make some predictions about the year to come. With the economy struggling, ad battles are sure to increase. The panel will ask whether this is a good thing for consumers or the industry.

Moderator
Christopher A. Cole, Partner, Manatt, Phelps & Phillips, LLP

Speakers
Steven H. Armstrong, Senior Food Law Counsel, Campbell Soup Company
Nicole Coutrelis, Partner, Coutrelis & Associes
Andrea C. Levine, Vice President, Council of Better Business Bureaus, Inc., and, Director, National Advertising Division
John M. Packman, Senior Counsel, Food Law, The Coca-Cola Company

12:00 Noon - 1:30 p.m.
Lunch with Speaker and FDAAA Wiley Award Recipient Henry A. Waxman,
(D-CA), U.S. House of Representatives

1:15 - 1:45 p.m.
VIII. Former Commissioner’s Reflections - Plenary
Former FDA Commissioner, Andrew C. von Eschenbach, MD will present and discuss lessons learned and answer questions about key challenges that the new Administration could expect to encounter.

1:45 - 2:30 p.m.
IX. Vision for Healthcare - Plenary
The new Administration has declared Healthcare Reform as a top priority with Healthcare Information Technology as the rallying point. Implemented correctly, HIT will not just digitize existing information but will transform healthcare, revolutionizing behavior, improving quality, safety, speed of care, and yes, even, lowering the cost. Done incorrectly – simply by converting existing information and processes to electronic form - and all the initiative will do is replicate the problems of the existing systems, create a massive administrative burden, and waste billions of taxpayer money. Tom Miller, a veteran of the medical technology and HIT industries will present his intriguing views on the peril and potential of the national Healthcare IT initiative.

Thomas J. Miller, CEO, Siemens Healthcare’s Workflow & Solutions Division

2:30 - 3:00 p.m.
Refreshment Break

3:00 - 4:15 p.m.
X. Legislative Outlook – FDA and the 111th Congress - Plenary
Hear from key Capitol Hill staffers involved in FDA focused committees in the new Congress discuss key healthcare reform challenges expected to be addressed by the Congress and the competing positions with respect to those challenges. Expected to be included are topics such as FDAAA implementation, product review processes, product safety issues (e.g., imported food and drugs), advertising, biosimilars, tobacco, user fees, third-party programs and the investigational agenda. Participants will be asked to vote to rank the priorities in their relative importance and vote on which side of the debate they favor. FDLI will publish the results and solicit potential articles to be published in Update or the FDLI Law Journal.

Moderators
Daniel A. Kracov, Partner Chair, FDA and Healthcare Practice, Arnold & Porter LLP and John R. Manthei, Partner, Latham & Watkins

Speakers
Charles M. Clapton, Chief Counsel, Minority Staff, Committee on Health, Education, Labor, and Pensions, U.S. Senate
David H. Dorsey, Senior Fellow, Majority Staff, Committee on Health, Education, Labor, and Pensions, U.S. Senate
Rachel Sher, Counsel, Majority Staff, Committee on Energy and Commerce, U.S. House of Representatives
Alan Slobodin, Chief Counsel, Minority Staff, Committee on Energy and Commerce, U.S. House of Representatives

4:15 - 5:00 p.m.
XI. Preemption - Plenary
Hard on the heels of its major decision on device preemption in Riegel v. Medtronic, the highest court in the land has now ruled emphatically on the issue of drug preemption in its Wyeth v. Levine decision. For those affected by that ruling, however – which includes just about everyone with a stake in the healthcare system – the debate over the its practical meaning is just beginning. Already several lower courts have had occasion to interpret and apply Wyeth v. Levine, and there will undoubtedly be many more such occasions over the coming years. This panel will examine the implications of this momentous preemption ruling for key stakeholders, including patients, plaintiffs, manufacturers, the FDA and other federal health agencies, and the courts.

Moderator
Geoffrey M. Levitt, Associate General Counsel and Chief Regulatory Counsel, Wyeth Pharmaceuticals

Speakers
Sheldon T. Bradshaw, former Chief Counsel FDA,
now Partner and Co-Chairman, Food and Drug Practice,
Hunton & Williams LLP
Bert W. Rein, Founding Partner, Wiley Rein LLP
David C. Vladeck, Professor of Law, Georgetown University
Law Center
Allison M. Zieve, Attorney, Public Citizen

Adjournment

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Featured Speakers

Agenda (preliminary)