The premier conference for the food and drug law community, the FDLI Annual Conference addresses every product category regulated by FDA.
- Hear FDA’s 2018 strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the Agency
- Join more than 800 colleagues in food and drug law to hear different viewpoints, shape policy, and advance understanding
- Select from nearly 30 breakout sessions covering the latest in legal, regulatory, compliance, policy, marketing, and related issues
- Learn from more than 100 well-known officials and experts
- Hear about the Top Cases in Food and Drug Law
- Network and build relationships with seasoned law, regulatory, compliance, marketing/advertising, and management professionals
- Scott Gottlieb, Commissioner of Food and Drugs, FDA
- Rebecca K. Wood, Chief Counsel, FDA
- Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis, FDA
- Peter W. Marks, Director, Center for Biologics Evaluation and Research (CBER), FDA
- Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition (CFSAN), FDA
- Jeffrey E. Shuren, Director, Center for Devices and Radiological Health (CDRH), FDA
- Steven M. Solomon, Director, Center for Veterinary Medicine (CVM), FDA
- Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER), FDA
- Mitchell R. Zeller, Director, Center for Tobacco Products (CTP), FDA
- International Harmonization Efforts
- First Amendment and the Regulatory Landscape
- Food Safety Modernization Act: Implementation Update
- Modified Risk Tobacco Products
- Data Integrity and Medical Products
- Use of Real World Evidence for Drugs and Devices
- 21st Century Cures Update
- Changing Environment of FDA Inspections
- Regulation of Medical Devices and 3-D Printing
- Evolving Regulatory Pathways
- Regenerative Medicine
- Regulation of Cell-Based Meat and Other Modified Foods
- Digital Health Regulation
- Cannabis and FDA-Regulated Products
Wednesday, May 2
5:30-7:00 PM | Out-of-Towners Reception
JW Marriott Hotel-Penn Avenue Terrace
Thursday, May 3
8:00–9:15 AM | Registration and Continental Breakfast | Atrium
Amy Comstock Rick, President & CEO, FDLI
Carla Cartwright, Director, Federal Affairs, Johnson & Johnson and Co-Chair, FDLI Annual Conference Planning Committee
Scott Gottlieb, Commissioner of Food and Drugs, FDA
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and Chair, FDLI Board of Directors
This panel features an interactive, forward-looking discussion on the bigger picture direction and anticipated short- and long-term issues facing FDA and the food and drug communities.
Daniel R. Dwyer, Partner, Kleinfeld, Kaplan & Becker, LLP
Lewis Grossman, Professor of Law, American University
Kathleen Hoke, Professor and Director, Network for Public Health Policy and Center for Tobacco Regulation, University of Maryland Carey School of Law
Sandra Kalter, Vice President and Chief Regulatory Counsel, Medtronic, and Member, FDLI Board of Directors
Howard R. Sklamberg, Partner, Akin Gump Strauss Hauer & Feld LLP
Moderated by Amy Comstock Rick, President & CEO, FDLI
11:00–11:30 AM | Coffee and Networking Break | Atrium
11:30–12:20 PM | Breakout Sessions
This session will bring together leading government regulators, legal advisors, and industry professionals to discuss and identify key issues emerging from the current data revolution. Speakers will explore potential use cases, potential pitfalls and regulatory challenges, and real-world implications of real world evidence, as well as the use of “real world evidence” to support regulatory decision making by both CDER and CDRH.
Owen Faris, Clinical Trial Director, Office of Device Evaluation, CDRH, FDA
John Manthei, Partner, Latham & Watkins LLP
Lisa Rachlin, Associate Director & Corporate Counsel, Vertex Pharmaceuticals, Inc.
Moderated by Meaghan Bailey, Executive Director, Medical Devices, NSF International
With the creation of the regenerative medicine advanced therapy (RMAT) designation in the 21st Century Cures Act and the announcement of substantive regulatory changes, FDA has taken unprecedented steps in the past year to advance the regulatory framework for human cells, tissues, and cellular- and tissue-based products (HCT/Ps). The panel will explore the legal and regulatory issues related to gene therapy, highlighting the agency’s latest actions, and discuss the impact of these changes on all affected stakeholders.
Anne Marie Polak, Senior Director, Leavitt Partners, LCC
Julie Tierney, Senior Policy Advisor for Strategic Planning and Legislation, CBER, FDA
Michael Werner, Partner, Holland & Knight LLP
Moderated by Barbara Binzak Blumenfeld, Partner, Buchanan Ingersoll & Rooney PC
Machine learning and 3D printed technologies for surgical planning and diagnosis; virtual reality in patient care; Artificial Intelligence in medical software: The future is here. Medical devices are at the cutting edge of today’s tech innovation trends. Experts in the field will share the regulatory challenges and benefits experienced with these transformative technologies.
Sonali Gunawardhana, Of Counsel, Shook, Hardy & Bacon LLP
Bakul Patel, Associate Director for Digital Health, CDRH, FDA
Zachary Rothstein, Associate Vice President, Technology & Regulatory Affairs, AdvaMed
Suzanne B. Schwartz, Associate Director for Science and Strategic Partnerships, CDRH, FDA
Moderated by Vernessa Pollard, Partner, McDermott Will & Emery LLP
Numerous companies are developing agricultural products such as “meat” and “poultry” from cell cultures instead of raising and slaughtering animals. At the same time, new traits are being introduced into crops and animals using gene editing techniques that are more precise than genetic engineering. These new products offer the promise of improved food safety and reduced environmental impact. Who will regulate these products? Through what regulatory pathway? What are the relevant issues to consider? How will they be labeled?
Robert G. Hibbert, Partner, Morgan, Lewis & Bockius LLP
Gregory Jaffe, Biotechnology Project Director, Center for Science in the Public Interest
Nicole Negowetti, Clinical Instructor, Harvard Food Law and Policy Clinic
Moderated by Stuart M. Pape, Shareholder, Polsinelli PC
Under the new FSMA requirements, the manufacturers of animal food are now responsible for complying with requirements for Current Good Manufacturing Practices (CGMPs) as well as preventive controls. How is the new regulatory scheme impacting companies’ operations and regulatory compliance mechanisms? What are the most pressing issues facing companies thus far with regards to compliance? What are FDA’s areas of focus?
Sonya Lambkin, Supervisor, Post-Market Compliance Animal Food Team, CVM, FDA
Anthony T. Pavel, Senior Food Lawyer, Cargill, Inc.
Richard Sellers, Senior Vice President of Public Policy and Education, American Feed Industry Association
Moderated by Riëtte van Laack, Director, Hyman, Phelps & McNamara, PC
Panelists will discuss FDA’s implementation of the PMTA and MRTPA pathways, as well as impacts on consumers, manufacturers, and tobacco harm reduction efforts, and the public health. Opportunities to clarify how the pathways will be implemented to foster innovation and advance tobacco harm reduction will also be addressed, including the current status of SE applications and the need, recognized by both industry and FDA, for a clear set of achievable requirements for SE applications.
Matthew Holman, Director, Office of Science, CTP, FDA
Joe Murillo, Vice President, Regulatory Affairs, Altria Client Services LLC
Daniel Schultz, Medical Devices & Combination Products, Greenleaf Health, Inc.
Moderated by Bryan M. Haynes, Partner, Troutman Sanders LLP
FDLI Distinguished Service and Leadership Awards
Presented by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and Chair, FDLI Board of Directors and Amy Comstock Rick, President & CEO, FDLI
David V. Ceryak, Senior Director – Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company
Ellen J. Flannery, Deputy Center Director for Policy, Office of the Center Director, CDRH, FDA
FDCA Anniversary Presentation
Presented by Suzanne Junod, Historian, Office of Communications, FDA History Office, FDA
Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis, FDA
Introduced by Frederick R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors
2:00–2:10 PM | Transition
2:10–3:25 PM | Breakout Sessions: FDA Center Directors
Hear directly from each of FDA’s Center Directors and learn about the latest policy developments, enforcement actions, and priority initiatives for 2018. A panel including multi-stakeholder perspectives will follow, along with time for questions from the audience.
Janet Woodcock, Director, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, FDA
Margaret Anderson, Managing Director, Deloitte Consulting LLP
Daniel A. Kracov, Partner, Arnold & Porter LLP and Member, FDLI Board of Directors
Peter Pitts, President, Center for Medicine in the Public Interest
Frances Zipp, President, Lachman Consultants
Moderated by Carla Cartwright, Director, Federal Affairs, Johnson & Johnson and Co-Chair, FDLI Annual Conference Planning Committee
Peter W. Marks, Director, Center for Biologics Evaluation and Research, Office of Medical Products and Tobacco, FDA
Margo Heath-Chiozzi, Senior Vice President, Regulatory Affairs, Celldex Therapeutics, Inc.
Christopher Mikson, Partner, Mayer Brown LLP
John Murphy, Deputy General Counsel for Healthcare, Biotechnology Innovation Organization
Moderated by Neil DiSpirito, Of Counsel, Ballard Spahr LLP and Co-Chair, FDLI Annual Conference Planning Committee
Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, Office of Medical Products and Tobacco, FDA
Khatereh Calleja, Senior Vice President, Technology and Regulatory Affairs, AdvaMed
Brian Dahl, Compliance Practice Lead, E.M.M.A. International Consulting Group, Inc.
Eric Rogers, Global Head, Regulatory and Development Law, Alcon Laboratories, Inc.
Moderated by Paul Gadiock, Senior Attorney, Arent Fox LLP
Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, Office of Foods and Veterinary Medicine, FDA
Sandra B. Eskin, Director, Safe Food Project, The Pew Charitable Trusts
Meredith Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Moderated by Martin Hahn, Partner, Hogan Lovells LLP
Mitchell R. Zeller, Director, Center for Tobacco Products, Office of Medical Products and Tobacco, FDA
Katherine Ciambrone, Chief Compliance Officer and Senior Vice President, ITG Brands
Stacey Gagosian, Managing Director of Public Policy, Truth Initiative
J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP
Moderated by Dean R. Cirotta, President & COO, EAS Consulting Group, LLC
Steven M. Solomon, Director, Center for Veterinary Medicine, Office of Foods and Veterinary Medicine, FDA
Jesse J. Sevcik, Sr. Director, Global Government Affairs, Elanco Animal Health
Peter Tabor, Vice President, Regulatory and International Affairs, Pet Food Institute
Moderated by Madeleine McDonough, Chair, Shook, Hardy & Bacon LLP
3:25–3:50 PM | Coffee and Networking Break | Atrium
3:50–4:50 PM | Breakout Sessions
Congress and FDA have both advanced efforts to enhance generic drug availability. Some efforts include changes to the generic drug user fee amendments (GDUFA), provisions in FDARA aimed at increasing transparency and providing assistance to certain generic drug sponsors, and new administrative proposals from FDA to accelerate the review of certain drugs. Panelists will assess these initiatives and discuss FDA’s current plan for implementation.
Jeffrey Francer, Senior Vice President & General Counsel, Association for Accessible Medicine (AAM), and Member, FDLI Board of Directors
Elizabeth Jex, Attorney Advisor, Office of Policy Planning, Federal Trade Commission
Maryll Toufanian, Acting Director, Office of Generic Drug Policy, CDER, FDA
Moderated by William B. Schultz, Partner, Zuckerman Spaeder LLP
This session will examine developments concerning biosimilars in the past year with particular attention to analytical similarity, reference product exclusivity, and an update on the “patent dance” and the resolution of patent disputes since the Supreme Court’s decision in Sandoz, Inc. v. Amgen, Inc.
Joseph Franklin, Associate Director for Policy, Therapeutic Biologics and Biosimilars Staff, CDER, FDA
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Daniel Orr, Partner, Womble Bond Dickinson (US) LLP
Christine M. Simmon, Executive Director, Biosimilars Council and Senior Vice President, Policy & Strategic Alliances, Association for Accessible Medicines
Over the past several years, there have been a number of regulatory developments related to digital health, including the 21st Century Cures Act, FDARA, and an ever-increasing amount of FDA guidance documents. This panel will discuss FDA’s proposed changes to how it regulates digital health products, the status of the precertification pilot, whether and how FDA can implement these significant changes without additional legislative changes, and what the new programs mean for digital health developers, consumers, and the healthcare system.
Mark R. Dahlby, FDA Regulatory and Healthcare Compliance Counsel, IBM
Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC, and Chair, FDLI Board of Directors
Bakul Patel, Associate Director for Digital Health, CDRH, FDA
Moderated by Nancy Stade, Partner, Sidley Austin LLP
FSMA is the first substantive change in over 70 years to the food safety system, and implementation has begun for all seven foundational rules. What has been industry’s experience with inspections and enforcement? What are the key concerns of industry going forward? Does the focus on prevention by industry seem to be effective? This session will look at early trends and discuss some of the key questions impacting implementation.
Steven H. Armstrong, Independent Advisor, EAS Consulting Group, LLC
Marc C. Sanchez, Regulatory Attorney, CIHCC, LLC
Jennifer Thomas, Interim Director for FSMA Operations, CFSAN, FDA
Claims that had been seen exclusively in human food lawsuits are now starting to show up in pet food litigation. This panel will examine the recent case law, NAD challenges, and FTC enforcement in the pet food arena, and consider the types of challenges the pet food industry may face in the future.
Adam Ekonomon, Vice President and Deputy General Counsel, J.M. Smucker Company
Emily M. Leongini, Associate, Arent Fox LLP
Moderated by Jeannie Perron, Partner, Covington & Burling LLP
Panelists will discuss the three recently issued Advanced Notices of Proposed Rulemaking on nicotine, flavors, and premium cigars. Discussion will focus on implications for tobacco harm reduction, product innovation and public health, and possible next steps as FDA implements its Comprehensive Plan for Tobacco and Nicotine.
Clive Bates, Director, Counterfactual Consulting Limited
Dennis Henigan, Vice President, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
Raymond Niaura, Professor, Department of Social and Behavioral Sciences, New York University
Moderated by Robyn Gougelet, Senior Associate, Pinney Associates, Inc.
4:50–5:00 PM | Transition
Rebecca K. Wood, Chief Counsel, FDA
Introduced by Francis B. Palumbo, Professor and Executive Director, University of Maryland School of Pharmacy and Member, FDLI Board of Directors
Friday, May 4
8:00–8:30 AM | Breakfast | Atrium
Neil DiSpirito, Of Counsel, Ballard Spahr LLP and Co-Chair, FDLI Annual Conference Planning Committee
Service to FDLI Award
Presented by Miriam Guggenheim, Partner, Covington & Burling LLP and Member, FDLI Board of Directors and Amy Comstock Rick, President & CEO, FDLI
Award Recipient: Steven H. Armstrong, Independent Advisor, EAS Consulting Group, LLC
Dr. Harvey W. Wiley Lecture and FDAAA 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.
Anthony S. Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Presented by Nancy Myers, President, Catalyst Healthcare Consulting
As manufacturing, sales, and product development become more global innature, government agency coordination and cooperation are increasingly relevant. This session will focus on international cooperation efforts, including FDA’s inspection recognition agreements as well as coordinated actions on imported products.
Benjamin L. England, Founder and CEO, FDAImports.com, LLC |Benjamin L. England & Associates, LLC
Leigh Verbois, Assistant Commissioner for International Programs (Acting), Office of the Commissioner, FDA
Domenic Veneziano, Independent Advisor for Import Operations, EAS Consulting Group, LLC
Moderated by Robert A. Rhoades, Managing Partner, Validant and Member, FDLI Board of Directors
10:00–10:30 AM | Coffee and Networking Break | Atrium
10:30–11:20 AM | Breakout Sessions
In late January, then-Associate Attorney General Brand released a memorandum announcing that DOJ will not use its civil enforcement authority to enforce agency guidance documents. This has the potential to impact FDA-regulated industry, as non-compliance with guidance documents will not be used to establish violations of the law. In this session, panelists will look into the history of DOJ cases to see where this policy may have impacted prior actions and will also consider the potential implications for both industry and FDA moving forward.
Michael S. Blume, Partner, Venable LLP
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Vice Chair, FDLI Board of Directors
John H. Fuson, Partner, Crowell & Moring LLP
This panel will address recently issued policy and procedures impacting FDA drug and device inspections, including the new Concept of Operations, the New Inspection Protocol Project, Quality Metrics, FDARA, program alignment, and other recent changes. It will highlight what these changes are and will give both FDA and industry viewpoints on the what impact these changes will have on inspection processes and on resolution of inspection issues.
Donald Ashley, Director, Office of Compliance, CDER, FDA
Cathy Burgess, Partner, Alston & Bird, LLP
Lori F. Hirsch, VP of Regulatory Compliance and External Engagement, Bristol-Myers Squibb Company
Moderated by Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health, Inc.
This session will address recent regulatory developments and key policy issues affecting orphan drugs. Topics to be addressed include FDA’s Orphan Drug Modernization Plan; the recent changes to orphan drug laws as part of the 21st Century Cures Act and FDARA; FDA’s implementation of the rare pediatric disease priority review voucher, orphan drug designation, and orphan drug exclusivity laws; and key policy issues regarding orphan drugs.
Debra Lewis, Acting Director, Office of Orphan Products Development, FDA
Adora Ndu, Executive Director, Regulatory Policy, Research & Engagement, BioMarin Pharmaceuticals, Inc.
Alexander J. Varond, Associate, Goodwin Procter LLP
Moderated by Krista Carver, Partner, Covington & Burling LLP
In May 2016, FDA published a final rule to update the Nutrition Facts Label. Changes in the effective date and new guidances covering compliance and declaration of dietary fiber and added sugars will impact implementation. Panelists will provide insight into evolving areas of the rule and challenges currently facing industry.
Leslie Krasny, Partner, Keller and Heckman LLP
Amy Norris, Chief Counsel, Clif Bar & Company
Moderated by Bruce Silverglade, Principal, Olsson Frank Weeda Terman Matz PC
Are we moving in the direction of a smoke-free world? What policies and behavior must be altered to reduce the demand for cigarettes? What technologies are available or required to transition to a smoke-free world? What can FDA do to facilitate these changes and technologies?
Moira Gilchrist, Vice President Scientific and Public Communications, Philip Morris International
Matthew Myers, President, Campaign for Tobacco-Free Kids
David Levy, Professor, Lombardi Comprehensive Cancer Center, Georgetown University
Moderated by Scott Ballin, Tobacco and Health Policy Consultant
The mobile sphere poses diverse advertising and marketing challenges and opportunities across all FDA-regulated industries. Panelists will explore recent FTC and FDA guidance, including how to approach the review and approval of such materials. In addition to providing updates on how to ensure that mobile apps comply with all relevant laws and regulations, advertising within mobile apps and other platforms will be discussed.
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, FTC
Toam Rubinstein, Associate, Reed Smith LLP
Moderated by Dale A. Cooke, President, PhillyCooke Consulting
11:20–11:30 AM | Transition
11:30–12:20 PM | Breakout Sessions
New flexibility for OTC monograph products will present opportunities and challenges. Panelists will discuss the prospects for final passage of legislation and implementation plans, including discussion of new processes and transition to the new system. Potential implications of the new rule for manufacturers and patients will also be addressed.
Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts, and Member, FDLI Board of Directors
David C. Spangler, Senior Vice President, Policy, and General Counsel & Secretary, Consumer Healthcare Products Association (CHPA)
Moderated by Deborah Livornese, Of Counsel, Arnall Golden Gregory LLP
In recent years, FDA has finalized several medical device guidance documents that could dramatically impact the regulatory pathways available to medical device manufacturers. Are manufacturers effectively taking advantage of these new options, for example, by leveraging non-traditional data sources, like real world evidence or patient preference information, for regulatory purposes? Are the new options making the regulatory process more efficient for manufacturers and FDA? Has FDA’s decision-making process been impacted by the new options?
Jonette Foy, Associate Director for Policy, CDRH, FDA
Judith O’Grady, Partner, Pepper Hamilton LLP
Rachel Turow, Executive Counsel – Regulatory Law, TEVA Pharmaceuticals USA, Inc.
Moderated by Cassie Scherer, Principal Legal Counsel, Corporate Legal Regulatory, Medtronic
FDA and CMS have been working together on many initiatives. Panelists will provide a background and overview of the tie in between FDA regulatory approval and the Medicare coverage process, and will address the endpoints that both agencies consider in their decision-making process and the ways in which the two agencies coordinate their efforts.
Rochelle Fink, Senior Health Science Project Specialist, CDRH, FDA
Linda Gousis, Senior Advisor, Coverage and Analysis Group, Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services (CMS)
Moderated by David R. Zook, Partner, Faegre Baker Daniels LLP
Federal agencies like FDA have largely taken a hands-off approach to regulating state-authorized cannabis activities. However, FDA has suggested that the agency would be looking into health claims made about medical cannabis products. This session will both offer a high-level overview of FDA’s (and DEA’s) authority over cannabis products, as well as discuss what, if any, role FDA will take in regulating cannabis products that may also fall under its purview. The panelists will also address foods and other FDA-regulated products to which cannabinoids are added.
Jonathan Havens, Associate, Saul Ewing Arnstein & Lehr LLP
Rick Scarpello, CEO and Founder, MC Brands LLC
Sara Beth Watson, Of Counsel, Steptoe & Johnson LLP
In July 2017, FDA announced a comprehensive approach to regulating tobacco and nicotine products that placed nicotine as the keystone of their efforts. A potential barrier to the success of this integrated approach is the widely-held belief that nicotine itself is the cause of smoking-related diseases, while science indicates that it is the byproducts of combustion that are responsible for the preponderance of harm. This panel considers how to overcome this risk communication challenge, as well as the array of opportunities and barriers to success.
Aruni Bhatnagar, Professor of Medicine and Distinguished University Scholar, University of Louisville
Azim Chowdhury, Partner, Keller and Heckman LLP
James Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
Moderated by Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker, LLP and Member, FDLI Board of Directors
Facilitated Table Topic Discussions
Led by a FDLI-member expert, these informal facilitated discussions provide an ideal way to engage with colleagues, gain new information, and share best practices on a hot topic in food and drug law. Attendees have the option to choose from one of the 30+ topics or enjoy open-seating during lunch.
1:30–1:35 PM | Transition
1:35-2:20 PM | Breakout Sessions
First Amendment issues continue to be prominent in all areas of FDA-regulated industry, including in scientific exchange, product promotion, and as a defense to lawsuits. This panel will discuss FDA and industry perspectives on First Amendment issues and the regulatory landscape in the wake of recent cases and FDA guidance and statements.
Maia Kats, Director of Litigation, Center for Science in the Public Interest
Kelly Goldberg, Vice President, Law/Senior Counsel for Biopharmaceutical Regulation, PhRMA
Lynn C. Tyler, Partner, Barnes & Thornburg LLP
Moderated by James N. Czaban, Partner, DLA Piper LLP
The recent passage of the new Medical Device Rule (MDR) in the EU requires action from manufacturers with regards to regulatory pathways and development timelines. Product updates need to be completed before 2020, and new notified bodies may have to be selected as early as of 2018. The new rules and compliance obligations also impact US companies doing business abroad. This session offers an analysis of requirements and practical advice for companies operating in the US and EU.
Christian Fulda, Partner, Jones Day
Jana Grieb, Counsel, McDermott Will & Emery LLP
Sarah H. Stec, Associate, Squire Patton Boggs LLP
Moderated by Robert Iser, Vice President, Parexel Consulting
Compounding remains a priority for FDA, with an announcement earlier this year of its “Compounding Priorities Plan.” The agency expects to produce significant new guidance documents and rules regarding cGMPs, bulk substances, and FDA-State partnerships. This session will explore FDA’s recent actions as well as current issues facing compounding pharmacy and outsourcing facility industries, including emerging legal and logistical issues for compounders.
Martine Hartogensis, Deputy Director, Office of Surveillance and Compliance, CVM, FDA
Rachael G. Pontikes, Partner, Reed Smith LLP
Lee Rosebush, Partner, Baker Hostetler LLP
Moderated by Joanne Hawana, Of Counsel, Mintz Levin Cohn Ferris Glovsky Popeo and PC
This panel will address the latest in dietary supplement issues, with an emphasis on recent activities and trends in litigation. Speakers will cover FDA’s current enforcement priorities and actions, retailer liability, and the status of the New Dietary Ingredient Guidance. Dietary supplement jurisdictional standards, as outlined in Amarin v. International Trade Commission will also be discussed.
Jean Frydman, Partner, Fox Rothschild LLP
Megan Olsen, Assistant General Counsel, Council for Responsible Nutrition
Suzanne Trigg, Partner, Haynes and Boone LLP
Panelists will discuss the potential opportunities and public healthchallenges associated with regulating tobacco products based on their relative risks, including differential tax treatment, use restrictions, manufacturing standards and accelerated product authorization pathways for reduced-risk products. Panelists will also compare and contrast tobacco harm reduction philosophies with alternative approaches.
Donald Becker, Assistant General Counsel, Turning Point Brands, Inc.
Scott Drenkard, Director of State Projects, Tax Foundation
Eric Lindblom, Director, Tobacco Control and Food & Drug Law, O’Neill Institute for National and Global Health Law, Georgetown Law
Moderated by Cynthia Cabrera, President, The Cating Group
2:20–2:30 PM | Transition
Speaker: Arthur L. Caplan, Drs. William F. and Virginia Connolly Mitty Professor of Bioethics and Founding Director, Division of Medical Ethics, New York University School of Medicine
Introduced by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Vice Chair, FDLI Board of Directors
Always informative and entertaining, this perennially popular session promises insight into the most significant litigation from 2017, and a look at cases to keep an eye on in 2018. Annual Conference attendees receive the companion publication, Top Food and Drug Law Cases 2017, and Cases to Watch, 2018.
Ralph F. Hall, Professor of Practice, University of Minnesota Law School
William M. Janssen, Professor of Law, Charleston School of Law
Erika F. Lietzan, Associate Professor, University of Missouri-Columbia School of Law
Moderated by August Horvath, Partner, Foley Hoag LLP
4:15 PM | Conference Adjournment
2018 Planning Committee
Director, Federal Affairs, Johnson & Johnson
Of Counsel, Ballard Spahr LLP
Stacey Gagosian, Managing Director, Public Policy, Truth Initiative
Martin Hahn, Partner, Hogan Lovells LLP
Lori Hirsch, VP of Regulatory Compliance and External Engagement, Bristol-Myers Squibb
John Manthei, Partner, Latham & Watkins LLP
Jeff Nelligan, Communications for the Deputy Commissioner for Global Regulatory Operations and Policy, FDA
Amy Norris, Chief Counsel, Clif Bar & Co.
Jeannie Perron, Partner, Covington & Burling LLP
Cassie Scherer, Principal Legal Counsel, Medtronic
William Schultz, Partner, Zuckerman Spaeder LLP
Julie Tierney, Senior Policy Advisor for Strategic Planning and Legislation, CBER, FDA
Michael Werner, Partner, Holland & Knight LLP
Continuing Legal Education (CLE)
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.
10 credits for Ohio
10 credits for Pennsylvania
10 credits for Virginia
Location and Overnight Accommodations
Ronald Reagan Building and International Trade Center
1300 Pennsylvania Avenue NW
Washington, DC 20004
Business attire is suggested and some meeting rooms may have cooler temperatures.
Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.
A block of rooms has been reserved at the JW Marriott for conference attendees. Reservations can be made online. The group rate is $319/night. Reservations must be received by April 15, 2018 in order to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.