Welcome | ATRIUM HALL Amy Comstock Rick, President & CEO, FDLI William B. Schultz, Partner, Zuckerman Spaeder LLP and Co-Chair, FDLI Annual Conference Planning Committee
8:45 – 8:55 AM
Service to FDLI Award | ATRIUM HALL Presented by Amy Comstock Rick, President & CEO, FDLI and Laura Brown, Director, Educational Programs, FDLI Award Recipient: Sarah Roller, Partner, Kelley Drye & Warren LLP
8:55 – 9:20 AM
Dr. Harvey Wiley Lecture and FDAAA Award | ATRIUM HALL 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. Richard Pazdur, Director, Oncology Center of Excellence, FDA Presented byNancy Myers, President, Catalyst Healthcare Consulting
How is FDA interacting with regulatory bodies in countries outside of the US? What are key priorities for both the US FDA and related agencies in other jurisdictions? In what collaborative programs is FDA engaged with other countries? During this panel, speakers will discuss some of the current legal and regulatory actions and trends in globalization and harmonization, including FDA’s involvement with the International Council for Harmonization, global issues in emerging technologies, and foreign inspections. Speakers will also address how to approach regulatory issues in a global business setting, how different regulatory schemes impact mergers & acquisitions, and the culture of compliance across foreign business units.
Anna Abram, Deputy Commissioner for Policy, Legislation and International Affairs, Office of the Commissioner, FDA Deborah M. Autor, Senior Vice President, Head of Strategic Global Quality and Regulatory Policy, Mylan Pharmaceuticals, Inc.
Howard R. Sklamberg, Partner, Akin Gump Strauss Hauer & Feld LLP
Moderated by James N. Czaban, Partner, DLA Piper LLP
Controlled substances are subject to both the Drug Enforcement Administration (DEA) and FDA regulation and requires coordination between the agencies to ensure compliance. The DEA is taking more aggressive enforcement actions against drug manufacturers, distributors, importers, exporters, pharmacies, and practitioners in response to the current opioid abuse crisis. This panel will explain what every controlled substance manufacturer, distributor, pharmacy, and practitioner must do to comply with federal controlled substance requirements and how FDA is involved in these processes and inspections, with a specific eye to recent actions by both agencies on opioids.
Larry K. Houck, Director, Hyman, Phelps & McNamara, PC Lynn Mehler, Partner, Hogan Lovells US LLP Loren Miller, Policy Section Chief, Diversion Control Division, DEA
Digital health technologies are rapidly integrating into healthcare and life sciences – from wearables in clinical trials to digital tools for disease management and clinical decision support. Many of these technologies are and will deploy machine learning and artificial intelligence. This panel will discuss how these new technologies are being integrated and how FDA’s role in regulation will continue to evolve. FDA’s recent discussion paper on AI devices, as well as the challenges of AI regulation generally, such as liability, quality assurance, and approval pathways for a product that continually evolves will also be discussed.
Wade Ackerman, Partner, Covington & Burling LLP Carla Cartwright, Director, Global Regulatory Policy, Johnson & Johnson and Member, FDLI Board of Directors Mark C. Levy, Partner, Eckert Seamans Cherin & Mellott, LLC Bakul Patel, Associate Director of Digital Health, CDRH, FDA
These fields have evolved drastically in recent years, leading FDA and others to call for regulatory clarification and reform. How should these advancements be regulated? What are the key considerations that should guide diagnostics regulatory reform moving forward? What has been the impact of recent guidance on the precision medicine industry? How might regulatory reform impact product development, manufacturing, and the use of diagnostics in clinical trials and treatment? How might the recent legislative and regulatory proposals ensure accuracy and reliability without stifling innovative technologies?
Elizabeth Hillebrenner, Associate Director for Scientific and Regulatory Programs, CDRH, FDA Aaron L. Josephson, Senior Director, ML Strategies LLC Eric M. Marshall, Senior Director, Leavitt Partners LLC Moderated by Elizabeth Richardson, Director, Health Care Products Project, The Pew Charitable Trusts
Canada, the US, and Mexico have recently achieved a new free trade agreement (USMCA). What are the new provisions under the USMCA that may affect trade of food and beverage products vis a vis NAFTA? This session will focus on international requirements, practical issues, and legal differences between Canada, the US, and Mexico regarding the importation and exportation of food and beverage products under the new trade agreement.
Jose Alberto Campos-Vargas, Partner, Sanchez Devanny Teresa A. Reguly, Partner, Torys LLP Sarah Roller, Partner, Kelley Drye & Warren LLP
FDA and CTP have focused recent efforts on limiting youth access to and appeal of electronic nicotine delivery systems (ENDS). Recent actions include targeted education on the dangers of e-cigarettes in the Real Cost Campaign and regulatory actions to ensure that flavored ENDS products are sold in ways that make them less accessible and appealing to minors. What are the results of these efforts? What are cutting-edge, evidence-based ways to prevent youth from initiating use of ENDS? What are the public health implications and concerns of these actions?
Clive Bates, Director, Counterfactual Consulting Limited Aruni Bhatangar, Professor of Medicine and Distinguished University Scholar, University of Louisville and Fellow, American Heart Association Tevi D. Troy, Vice President of Public Policy, JUUL Labs Moderated by Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker, LLP and Member, FDLI Board of Directors
What are the latest trends in federal investigations in the drug, device, and food space? How does a company know if a parallel investigation is underway, and how does that affect the course of an investigation? In this panel, speakers will discuss FDA and DOJ enforcement priorities and provide best practices for conducting an internal investigation. Learn when you need to do an Upjohn warning and how to do one well to avoid consequences. Speakers will also provide guidance on specific types of investigations, such as cGMP or data integrity, marketing practices, and safety reporting.
John Bentivoglio, Partner, Skadden, Arps, Slate, Meagher & Flom LLP John Claud, Assistant Director, Consumer Protection Branch, US Department of Justice
William F. Gould, Partner, Holland & Knight LLP Moderated byBeth P. Weinman, Counsel, Ropes & Gray LLP
How far can orphan drug exclusivity extend and can FDA require clinical superiority for the same drug? What are the implications of sub-classifications of rare diseases for clinical trials, drug developers, regulators, industry, and payers? This panel will explore the history of the Orphan Drug Act, the concept of clinical superiority for drugs with the same active moiety, and the principles of drug development in the rare disease setting.
Kendra Martello, Executive Director, Public Policy and Corporate Social Responsibility, Mallinckrodt Pharmaceuticals Adora Ndu, Executive Director, Global Regulatory Policy, Research & Engagement, BioMarin Pharmaceutical Inc. Julia (Julie) Tierney, Senior Policy Advisor for Strategic Planning and Legislation, CBER, FDA Moderated by Brian J. Malkin, Counsel, Arent Fox LLP
Drug manufacturing is often global in nature, with multiple parties involved throughout the supply chain process, creating potential risks in ensuring product safety and efficacy. Panelists will delve into some of the important considerations manufacturers may encounter along the way, including regulatory requirements for servicing vs. remanufacturing, how to assign vulnerability and risk in virtual manufacturing networks, and how to establish appropriate metrics that are in line with the latest FDA guidance and at the same time drive the desired business results. Also, panelists will discuss inspectional issues including ConOps, OAI classification letters, and risk mitigation opportunities.
Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors Lori F. Hirsch, VP of Regulatory Compliance and External Engagement, Bristol-Myers Squibb Company John McShane, Managing Partner, Validant
Today, national health authorities are requiring cybersecurity and privacy considerations and supporting programs to be part of medical product design, development, and maintenance. This is especially true for conducting clinical trials, marketing activities overseas, and interoperability of medical devices and machine learning in clinical care. This session will address current privacy, cybersecurity, and data protection requirements such as the EU GDPR and the forthcoming California Consumer Privacy Act (CCPA), where a duty to protect personal data applies; and how to ensure there is full informed consent – issues that need to be top of mind for drug and device companies.
Seth Carmody, Cybersecurity Program Manager, CDRH, FDA Kimberly J. Gold, Partner, Reed Smith LLP
Tara Sklar, Professor of Health Law, University of Arizona
“Sugar,” “natural,” and “clean label” – oh my! Food label claims are at the forefront of current consumer focus and litigation trends. This includes the broad-ranging cereal cases, with their alleged health halo marketing; ABA v. San Francisco, on the city’s attempt to impose warning notices on advertising; advancement of “natural” and “artificial” cases in light of FDA non-action; and the clean label movement. This panel will discuss the hot areas currently being seen in label claim litigation and challenges companies face when responding to consumers with new and improved products and labels.
Susan M. Bond, VP, Regulatory and Scientific Affairs, Kerry, Inc. Maia C. Kats, Of Counsel, Kaplan Fox & Kilsheimer, LLP Suzie L. Trigg, Partner, Haynes and Boone LLP
ENDS may play an important role in public health by providing an alternative to combustible cigarettes for current adult smokers. At least one recent study has shown that traditional smokers were more likely to quit combustible products by switching to e-cigarettes than people who used other cessation methods, such as nicotine patches or gum. Speakers will discuss how new technologies can encourage adult smokers to switch to a less harmful product while still getting access to nicotine, the public health benefits and concerns of adults switching to non-combustible products, and marketing strategies to target adults.
Aruni Bhatangar, Professor of Medicine and Distinguished University Scholar, University of Louisville and Fellow, American Heart Association Katherine Ciambrone, Legal, Regulatory & External Affairs – US, Fontem Ventures Gregory Conley, President, American Vaping Association Moderated byRobyn Gougelet, Senior Associate, Pinney Associates, Inc.
Cannabis-related substances, whether marijuana, cannabidiol (“CBD”), or hemp, appear in the news daily. Much is happening on the federal and state regulatory fronts with respect to those substances. FDA recently approved Epidiolex, a CBD product, DEA rescheduled certain CBD products from schedule I to schedule V, and Congress, with passage of the 2018 Farm Bill, removed hemp from the federal Controlled Substances Act. FDA is also considering its options for potential regulatory pathways for cannabis products. Speakers will address the current state of regulation and where we might be headed in the near future.
Miriam Guggenheim, Partner, Covington & Burling LLP and Member, FDLI Board of Directors Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP Sarah Sorscher, Deputy Director of Regulatory Affairs, Center for Science in the Public Interest (CSPI)
Led by FDLI-member experts, 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.
The tools provided to FDA under the 21st Century Cures Act have been used by CBER to promote the development of new gene, cell, and tissue therapies. We have seen trends emerging in the regenerative medicine/stem cell fields, including science-based development of cell therapies via the RMAT designation in the Cures Act, and efforts FDA is taking to regulate rogue stem cell clinics.
Marc J. Scheineson, Partner, Alston & Bird LLP
Michael Werner, Partner, Holland & Knight LLP Celia M. Witten, Deputy Director, CBER, FDA Moderated by Joanne Hawana, Member, Mintz, Levin, Cohen, Ferris, Glovsky and Popeo, PC
It is only since the passage of PDUFA V in 2012 that we have seen a major focus by FDA and companies on Patient-Focused Drug Development (PFDD). This session will take a closer look at how the rapidly developing field of PFDD has introduced specific legal and/or regulatory compliance issues that, in some regard, are different than what sponsors encounter in a “traditional” drug development process (e.g., clinical trials compliance). Speakers will address the discussion documents and early drafts of the yet-to-be-released FDA PFDD-related guidances, which will provide a more specific look at FDA’s thinking, and discuss potential compliance issues related to PFDD.
Andrea Furia-Helms, Director of Patient Affairs Staff, FDA Annie Kennedy, Senior Vice President, Legislation & Public Policy, Parent Project Muscular Dystrophy David R. Zook, Partner, Faegre Baker Daniels LLP Moderated by Eleanor Perfetto, Executive Vice President, Strategic Initiatives, National Health Council
With the ongoing implementation of the 21st Century Cures Act, including the recently released guidance for industry, “Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff,” where does the current regulatory landscape stand for combination products? This session will discuss regulatory challenges for products and whether there are alternative pathways to market, including for products that have a digital health element. Panelists will also discuss improvements in human factors review for combination products, impacts of FDA’s digital health programs on combination digital health products, and recent approval of generic combination products.
Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and Immediate Past Chair, FDLI Board of Directors Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals USA, Inc. John (Barr) Weiner, Associate Director for Policy and Product Classification Officer, Office Combination Products, FDA
Moderated by Nathan A. Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
As the market continues to become more global in all areas of FDA regulated products, it is imperative that both industry and the regulating bodies understand the overlaps of jurisdiction. FDA has been exploring international convergence of some of its policies and processes as it continues to work under the auspices of the International Medical Device Regulators Forum (IMDRF), which aims toward regulatory harmonization. This forum also addresses the Medical Device Single Audit Program, adoption of ISO 13485, and Unique Device Identifiers (UDI). The impact of these processes on companies, as well as the new EU Medical Device Regulation (EU MDR) requirements on post-market surveillance planning and vigilance reporting, will be discussed.
FDA’s authority requires it to maintain a responsive premarket review program for ingredient additives with decisions based on the best-available science. FDA must vouch for the safety of new ingredients, and industry must be able to rely on FDA processes in order to move forward with product innovation. However, consumers are confused about ingredient safety, efficacy, and representation. This panel will consider the current state of food additive approvals, the GRAS process, where the Delaney Clause comes in, and the future of food additive reform.
Ricardo Carvajal, Director, Hyman, Phelps & McNamara, PC Dennis Keefe, Director, Office of Food Additive Safety, CFSAN, FDA Mark Mansour, Partner, Locke Lord LLP
What’s the latest in tobacco and nicotine litigation? Panelists will provide an update on recent and current cases, including: lawsuits against e-cigarette manufacturers on a variety of claims including product safety; the American Academy of Pediatrics case in Maryland challenging FDA’s decision that delays requirements of the Deeming Rule and enables electronic cigarettes and cigars to remain on the market prior to agency review; and the outcome of the recent case compelling FDA to require graphic warning labels on cigarette packages and advertisements.
Eric Gotting, Partner, Keller and Heckman, LLP Eric Heyer, Partner, Thompson Hine LLP Moderated byTara Lin Couch, Senior Director of Dietary Supplement and Tobacco Services, EAS Consulting Group, LLC
Always informative and entertaining, this perennially popular session promises insight into the most significant litigation from 2018, and a look at cases to keep an eye on in 2019. Annual Conference attendees receive the companion publication, Top Food and Drug Law Cases 2018, and Cases to Watch, 2019.
Ralph F. Hall, Professor of Practice, University of Minnesota Law School William M. Janssen, Professor of Law, Charleston School of Law Erika Lietzan, Associate Professor, University of Missouri-Columbia School of Law
Moderated byAugust T. Horvath, Partner, Foley Hoag LLP