Why Attend

Last Year’s Agenda

Location & CLE

A preliminary agenda will be announced in January 2023. If you would like to be notified, please let us know.

Tuesday, June 14, 2022

Amy Comstock Rick, President & CEO, FDLI
Vernessa T. Pollard, Partner, McDermott Will & Emery and Co-Chair, 2022 FDLI Annual Conference

Robert Califf, Commissioner of Food and Drugs, FDA
Introduced by Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors

 

Mark J. Raza, Chief Counsel, FDA 

The COVID-19 pandemic highlighted the benefits – and detriments – of FDA, a historically science-based agency, being in the public eye. Between the pandemic and other recent high-profile FDA actions, is FDA viewed as swayed by politics? Has the media accurately and appropriately covered significant FDA actions and policies, and what is the effect of this influence? Panelists will discuss these questions as well as the impact of politics on FDA decision making, career employees, and what the past few years mean for the interplay of FDA and its public role moving forward.

 

 

Holly Fernandez Lynch, John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics, University of Pennsylvania
Stephen Ostroff, Public Health and Regulatory Consultant, S. Ostroff Consulting and Medical Science Trustee, USP
Lowell J. Schiller, Chief Legal and Regulatory Officer, Aetion, Inc.
Joshua M. Sharfstein, Vice Dean for Public Health Practice and Community Engagement, Johns Hopkins Bloomberg School of Public Health
Moderated by Amy Comstock Rick, President & CEO, FDLI

Carol Cave, Deputy Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, FDA

FDLI Distinguished Service and Leadership Award
The FDLI Distinguished Service and Leadership Award, established in 1993, recognizes individuals who have made notable contributions to the food and drug law community through their leadership.

 

Award Recipients:
Andrea Chamblee, Senior Counsel, Wilson Sonsini
Daniel R. Dwyer, Partner, Kleinfeld, Kaplan & Becker, LLP
Jarilyn Dupont, Director of Regulatory Policy, Office of the Commissioner, FDA
Presented by Amy Comstock Rick, President & CEO, FDLI and
Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors

2:00–3:00 PM | Concurrent Breakout Sessions 1

During this session, FDA leadership will address the top issues CVM is facing as well as priorities and goals for the coming year.

 

Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
Moderated by Keith A. Matthews, Of Counsel, Wiley LLP

FDA’s Accelerated Approval Program allows for the earlier approval for drugs to treat serious conditions for which there is an unmet medical need. While a very important and valuable pathway, recent high-profile approvals and withdrawals and the CMS decision to narrowly cover an FDA-approved drug has led to a seeming lack of transparency and clarity on appropriate use of the pathway. This panel will discuss the current regulatory process and whether changes are needed to reinforce the existing areas where accelerated approval has been successful, challenges to the current pathway including timing of confirmatory trials, and potential modifications to the pathway that are currently being debated in Congress.

 

Jeff Allen, President & CEO, Friends of Cancer Research
David V. Ceryak, Senior Director, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company
Marc Theoret, Deputy Director, Oncology Center of Excellence, FDA & Supervisory Associate Director (Acting), Office of Oncologic Diseases, CDER, FDA
Moderated by William B. Schultz, Partner, Zuckerman Spaeder LLP

FDA has begun to approve interchangeable biosimilars, which raise a host of complex and challenging legal issues relating to exclusivity, labeling, automatic substitution, and the need for switching studies. During this session, speakers will discuss what can be learned from the first interchangeable approvals and what it tells us about FDA’s interchangeability framework. Speakers will also address what’s next, including what the competitive landscape for biologics looks like, how the statutory standard regarding “any given patient” may play out, and whether applicants will be able to use real-world evidence to support interchangeable licensure.

 

Brian Burgess, Partner, Goodwin Procter LLP
Brian C. Stone, Associate General Counsel, Global Legal-Regulatory, Viatris Inc.
Eva Temkin, Partner, King & Spalding LLP

Al/ML-based technologies have the potential to transform healthcare through their unique ability to learn from real-world feedback and adapt based on these learnings. However, the data that is used to learn may drive inherent biases. What can FDA and companies to do ensure that AI/ML-enabled products do not reproduce or amplify existing inequalities? This session will explore how biases from collection can degrade AI/ML algorithm performance and what tools FDA and companies can use to help combat bias.

 

Matthew Diamond, Chief Medical Officer, Digital Health Center of Excellence, CDRH, FDA
Jonelle Saunders, Associate Product Counsel, Google Health
Bradley Merrill Thompson, Member of the Firm, Epstein Becker & Green, PC
Moderated by Vernessa T. Pollard, Partner, McDermott Will & Emery and Co-Chair, 2022 FDLI Annual Conference

More than 300 class action lawsuits were filed against the food and beverage industry last year. What is causing the increase in cases, and what are the predominant areas being litigated? This panel will delve into some of the key focus areas of recent class action cases, including front-of-pack claims, ingredient representation and origin, ‘reasonable consumer’ defenses, sugar-related litigation, and scrutiny of class action settlements.

 

David L. Biderman, Partner, Perkins Coie LLP
Dale J. Giali, Partner, Mayer Brown LLP
Maia Kats, Managing Attorney, Just Food Law PLLC
Christopher Van Gundy, Partner, Sheppard Mullin Richter & Hampton LLP

Since enactment of the “Deeming Rule,” Electronic Nicotine Delivery System (ENDS) products have been regulated as “tobacco products,” subject to the requirements of the Tobacco Control Act. Thus, in order to stay on the market, they were required to submit a Premarket Tobacco Application (PMTA) by September 9, 2020 and receive a marketing order from the FDA. The Agency did not anticipate the nearly 6 million applications it received and ended up issuing Marketing Denial Orders arguably not in accordance with the rule and guidance it set forth outlining PMTA requirements. As a result, multiple companies brought legal action against the FDA for acting in an arbitrary and capricious manner. This panel will explore key cases, including any active litigation challenging FDA denial of PMTAs.

 

Micah L. Berman, Associate Professor of Public Health and Law, The Ohio State University
Paul Blair, Vice President, Government Affairs, Turning Point Brands, Inc.
Eric Heyer, Partner, Thomson Hine LLP
Moderated by Barry Schaevitz, Partner, Fox Rothschild LLP

3:15–4:15 PM | Concurrent Breakout Sessions 2

During this session, FDA leadership will address the top issues CDER is facing as well as priorities and goals for the coming year.

 

Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research, FDA 
Moderated by Patti Zettler, Associate Professor of Law, The Ohio State University and Member, FDLI Board of Directors

Gene therapies have provided great promise for medical advances, and viral vectors have also contributed to the pandemic response. But with these advances have come significant challenges, from clinical trial holds and application delays, to commercialization and manufacturing obstacles. In addition, FDA has raised safety questions about the inherent risks of viral vectors and higher doses. This session will address the legal and regulatory concerns for these new therapies, how to best overcome these challenges, and discuss the new resources for cell and gene therapies that are expected from PDUFA VII.

 

Wilson W. Bryan, Director, Office of Tissues and Advanced Therapies, CBER, FDA
Mantej (Nimi) Chhina, Senior Director, Global R&D and Regulatory Policy, BioMarin Pharmaceutical, Inc.
Nathan C. Sheers, Partner, Paul Hastings, LLP
Moderated by Kalah Auchincloss, Executive Vice President and Deputy General Counsel, Greenleaf Health, Inc.

The frequent exchange and transmission of medical device-related health information, as well as recent cybersecurity incidents that have impacted patient care, means that cybersecurity must be an integral part of device safety and effectiveness. In April 2022, the FDA released a draft guidance on quality system considerations and premarket submissions to address how companies can design for security and manage cybersecurity risks. Speakers will discuss implementation of the guidance and provide insight into to identifying vulnerabilities, responding to incidents, and placing safeguards to reduce security breaches when using and servicing medical devices.

 

Dana-Megan Rossi, Director of Information Security, WW Regional Cybersecurity Officers, BD
Zach Rothstein, Senior Vice President, Technology & Regulatory Affairs, AdvaMed
Suzanne Schwartz, Director, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
Moderated by Marian J. Lee, Partner, Gibson, Dunn & Crutcher LLP

What’s new in the world of dietary supplements? This session will address the issues front-and-center for dietary supplement companies and regulators. Speakers will examine recent legislation related to dietary supplements and the potential impact on industry, discuss FDA’s current priorities for dietary supplement product regulation, and address current challenges facing the industry, from litigation to supply concerns.

 

Steven M. Mister, President and Chief Executive Officer, Council for Responsible Nutrition
David C. Spangler, Senior Vice President, Legal, Government Affairs & Policy, Consumer Healthcare Products Association and Member, FDLI Board of Directors
Cara Welch, Director, Office of Dietary Supplement Programs, CFSAN, FDA
Moderated by Diane C. McEnroe, Partner, Sidley Austin LLP

This panel will focus on whether the PMTA process adequately accounts for the protection of public health. Panelists will consider the process itself, as well as the application of this process via FDA’s marketing approval and denial orders. Speakers will also consider the potential policy implications of FDA’s PMTA decisions, what the PMTA process gets wrong and whether it can be improved within the current statutory confines, and whether this process means that PMTA products are regulated in a way that does not effectively contribute to the reduction of the negative health effects of tobacco use.

 

David L. Ashley, Research Professor, Department of Population Health Sciences, Georgia State University
Aruni Bhatnagar, Professor of Medicine and Distinguished University Scholar, University of Louisville
Jason W. Flora, Associate Fellow, Regulatory Affairs, Altria Client Services
Christopher Junker, Vice President, Scientific & Regulatory Affairs, RAI Services Company
Moderated by Thomas J. Glynn, Adjunct Lecturer, Stanford University

In 2017 FDA released a draft revised guidance for industry regarding the regulation of intentional genomic alterations (IGA) in animals. In late 2020, CVM approved the first IGA, in GalSafe pigs, for both human food consumption and as a source of potential therapeutic uses. This session will cover legal and regulatory challenges IGA product industries may encounter moving forward, including what developers can expect from the regulatory process. Panelists will also consider what might be on the horizon regarding promising uses of these products from both the biomedical and agricultural perspectives, as well as what FDA can do to encourage development of more products in this space.

 

Laura Epstein, Senior Policy Advisor, CVM, FDA
Jaydee Hanson, Policy Director, Center for Food Safety
Alison Van Eenennaam, Professor of Cooperative Extension, University of California-Davis
Moderated by Kristin M. Kaplan, Of Counsel, Shook, Hardy & Bacon LLP

4:30–5:30 PM | Concurrent Breakout Sessions 3

During this session, FDA leadership will address the top issues CDRH is facing as well as priorities and goals for the coming year.

 

Jeffrey Shuren, Director, Center for Devices and Radiological Health, FDA 
Moderated by Melanie Katrice Gross, Associate General Counsel & Practice Group Leader, Healthcare Law Group, Genentech, Inc. and Member, FDLI Board of Directors

Interacting with the FDA can prove challenging for attorneys and regulated industry. Engaging with FDA and effectively use both long-standing and recently established programs appropriately can reduce miscommunication issues and advance resolutions. This session will highlight communication strategies and discuss who and when to contact certain FDA officials for resolution in order to navigate regulatory challenges more efficiently. Speakers will also discuss lesser-known resources, like FDA’s ombudsman programs, and the role of mainstream tools, like listening sessions and public comment on agency policies.

 

Laurie Lenkel, Ombudsman, Office of the Chief Scientist, FDA
Ken Skodacek, Deputy Ombudsman, CDRH, FDA
Jessica L. Zeller, Vice President, Quality, Regulatory & Public Affairs Counsel, Edwards Lifesciences
Lowell M. Zeta, Partner, Hogan Lovells US LLP
Moderated by Cynthia Schnedar, Principal, Regulatory Compliance, Greenleaf Health, Inc. and Member, FDLI Board of Directors

COVID-19 prompted changes to accommodate trial participants that may continue post pandemic, such as decentralized trials and use of digital tools. Recent events have also brought to light the importance of clinical trial diversity to further improve public health accessibility and equity. This session will provide a discussion of legal and regulatory shifts in clinical trials and how they are conducted, data privacy law concerning global data collection, the increased focus on diversity in clinical trials, use of real-world data, and digital tools as a means of data collection. It will provide clarity about global clinical trial compliance, regulatory challenges, and possibilities for the future.

 

Lola Fashoyin-Aje, Deputy Division Director & Associate Director, Science & Policy to Address Disparities, Oncology Center of Excellence, FDA
Kimberly Gold, Chief Privacy Officer, Genentech, Inc.
Peter V. Lindsay, Partner, Paul Hastings, LLP
Peter Stein, Director, Office of New Drugs, CDER, FDA
Moderated by Stacy Cline Amin, Partner, Morrison & Foerster, LLP

The market for plant-based and alternative proteins continues to grow especially as consumers become more health and environmentally conscious. These innovative products also have novel legal and regulatory considerations. This panel will delve into the current regulatory landscape and the distinctions between plant-based and cell-cultivated products, discuss FDA’s approach to new technologies, address labeling concerns and recent litigation, and where plant-based milks fit into the above.

 

Jeremiah Fasano, Senior Policy Advisor, Office of Food Additive Safety, CFSAN, FDA
Kelly G. Laudon, Of Counsel, Jones Day
Nicole Negowetti, Vice President of Policy & Food Systems, Plant Based Foods Association
Moderated by Jessica Tierney, Senior Counsel, Thompson Hine LLP

Both domestically and abroad, many public and private public health agencies have called for a cigarette smoking rate of 5% or less by the year 2030, and one major tobacco manufacturer—Philip Morris International—has stated it will stop selling cigarettes in the United Kingdom by 2030. Given the widespread consensus that smoking is harmful, what are the tangible steps that can or should be taken by Congress, FDA, industry, public health, and other tobacco and nicotine product stakeholders to move smokers away from combustible tobacco? Panelists will discuss strategies for moving smokers down the continuum of risk in light of unique U.S. legal obstacles, as well as potential unintended consequences.

 

Clifford E. Douglas, Director, Tobacco Research Network and Adjunct Professor, Department of Health Management and Policy, University of Michigan School of Public Health
J.B. Simko, Vice President, External Affairs, Philip Morris International
Joe Murillo Chief Regulatory Officer, JUUL Labs
Moderated by Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker, LLP

This panel will provide an interactive discussion that will help attendees prepare for the inevitable end of federal prohibition on cannabis. The panel will discuss, among other things: 1) transition of the cannabis industry from primarily state regulation to a hybrid federal/state regulatory regime and what can be learned from current state regulations; 2) FDA’s regulatory role, and how they should interact with other federal regulators and state cannabis commissions; and 3) lessons that can be learned from other industries, such as tobacco, with regards to federal regulation, ensuring policy doesn’t perpetuate inequities and disparities, and ensuring safe product use.

Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP
Pritika Kumar, Senior Fellow, Integrated Harm Reduction Policy, R Street Institute
Raymond Niaura, Professor, Department of Social and Behavioral Sciences, New York University
Moderated by Frederick R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors

Remarks recognizing the public service of Mitch Zeller, former Director, Center for Tobacco Products, FDA

Wednesday, June 15, 2022

Laura Brown, Director, Educational Programs, FDLI
Meredith Quinn Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company and Co-Chair, 2022 FDLI Annual Conference

The Service to FDLI Award, established in 2017, honors FDLI members who have provided exceptional volunteer services to FDLI, furthering FDLI’s mission as a neutral convener to educate and spark innovative change.

 

Award Recipient: Stuart M. Pape, Senior Partner, Polsinelli PC
Presented by: Laura Brown, Director, Educational Programs, FDLI and
Paige Samson, Director, Innovative Programs and Publications, FDLI

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.

 

Janet Woodcock, Principal Deputy Commissioner, Office of the Commissioner, FDA
Introduced by Deborah M. Autor, CEO, Autor Strategies; Non-Executive Director, Pardes Biosciences; and Chair, Board of Directors, FDA Alumni Association

During this panel, industry in-house counsel and executives will discuss challenges faced by FDA-regulated companies. They will examine the wide breadth of current matters challenging industry, including navigating regulatory uncertainty, changes arising from COVID-19 and moving beyond the pandemic, cybersecurity, enforcement by other agencies, social responsibility, and what they anticipate for the future.

 

Kenita Barrow, Deputy General Counsel, Legal Affairs, Otsuka America Pharmaceutical, Inc.
Amy Norris, Executive Counsel, Clif Bar and Secretary and General Counsel, FDLI Board of Directors
Steven Przybyla, General Counsel, 22nd Century Group, Inc.
Ami Simunovich, Executive Vice President, Chief Regulatory Officer, BD
Jennifer Zachary, Executive Vice President and General Counsel, Merck & Co., Inc.
Moderated by Freddy Jimenez, Senior Vice President and General Counsel, Celldex Therapeutics, Inc. and Vice Chair, FDLI Board of Directors

11:05 AM–12:05 PM | Concurrent Breakout Sessions 4

Michele Mital, Acting Director, Center for Tobacco Products, FDA

Hear directly from those negotiating the user fee program reauthorization for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA) on the current state of the goals letters and accompanying omnibus reauthorization legislation. Speakers will address FDA-related policy priorities set forth in the legislation and the regulatory and legal impacts for industry.

 

Katlin McKelvie Backfield, Deputy Health Policy Director and Senior FDA Counsel, Committee on Health, Education, Labor and Pensions, U.S. Senate
Margaret Coulter Martin, Senior Health Policy Advisor, Committee on Health, Education, Labor and Pensions, U.S. Senate
Kelly F. Goldberg, Vice President, Law & Senior Counsel for Biopharmaceutical Regulation, PhRMA
Moderated by Wade Ackerman, Partner, Covington & Burling LLP

FDA’s regulation of and policies on orphan drug designations and exclusivities continue to evolve and be challenged in court, sometimes with surprising results given FDA’s prior regulation of this area. A recent example is the Catalyst decision, which seems to broaden the scope of orphan drug exclusivity. This panel will discuss how FDA may implement or respond to this and what additional modifications to the Orphan Drug Act might be made in light of Catalyst and other recent decisions. Speakers will also address new regulatory developments, including FDA’s new guidance on “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations” and potential areas of risk and remaining uncertainties for sponsors.

 

Brian J. Malkin, Partner, McDermott Will & Emery
Andrew D. Prins, Partner, Latham & Watkins LLP
Heidi Ross, Vice President, Policy and Regulatory Affairs, National Organization for Rare Disorders (NORD)
Michael K. Stern, Of Counsel, Covington & Burling LLP
Julia C. Tierney, Chief of Staff, Office of the Commissioner, FDA
Moderated by Rachel Sher, Partner, Manatt, Phelps & Phillips, LLP

Enforcement risks for medical device companies range from FDA enforcement actions to government investigations to litigation. During this panel, speakers will discuss the uptick in enforcement actions from FDA, including increased resources to carry out these actions. Speakers will also address areas of focus for government enforcement and litigation, including COVID and laboratory testing, and as well as new–and old–legal theories being utilized.

 

James C. Fraser, Shareholder, Greenberg Traurig, LLP
Ross Goldstein, Assistant Director, Consumer Protection Branch, U.S. Department of Justice
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
Moderated by Gregory H. Levine, Partner, Ropes & Gray LLP

The FDA Food Safety Modernization Act (FSMA) has aimed to transform the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. How successful has the new structure been in increasing food safety? During this panel, speakers will consider enforcement and compliance actions as well as recalls to highlight the changes FSMA has brought about, FDA’s priorities, and areas where improvements in food safety is still needed. Speakers will then discuss what’s next, as FDA implements its New Era of Smarter Food Safety.

 

Greg Bikofsky, Independent Consultant, EAS Consulting Group, LLC
Meredith Quinn Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company and Co-Chair, 2022 FDLI Annual Conference
Ann M. Oxenham, Director, Office of Compliance, CFSAN, FDA
Moderated by Suzie Trigg, Partner, Haynes and Boone LLP

The changing media landscape has led to the rise of new ways of marketing to consumers and the use of influencers. Companies have been engaging with these new venues, but the compliance concerns are real, and both FDA and FTC are taking action. The FTC has put over 700 food, OTC drugs, cosmetics, and dietary supplement companies on notice that it plans to use its Penalty Offense Authority to deter fake reviews and deceptive endorsements in the online world. This panel will discuss why FTC resurrected this enforcement tool, how to market effectively on new and cutting-edge social media platforms, and pitfalls brands and advertisers face as the FDA and FTC take a hard look at their enforcement priorities.

 

Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission
Jason W. Gordon, Partner, Reed Smith LLP
Alan G. Minsk, Partner, Arnall Golden Gregory LLP
Sarah H. Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson

1:00–2:00 PM | Concurrent Breakout Sessions 5

During this session, FDA leadership will address the top issues CFSAN is facing as well as priorities and goals for the coming year.

 

Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA
Douglas W. Stearn, Deputy Director, Regulatory Affairs, CFSAN, FDA
Moderated by Ricardo Carvajal, Director, Hyman, Phelps & McNamara, PC and Member, FDLI Board of Directors

With signs that the pandemic may be waning, what does this mean for FDA and industry as we transition to a post-pandemic world? This panel will address what COVID-related work we expect FDA to continue and whether resources might be diverted back to other initiatives, whether some flexibilities that were provided during COVID may become permanent, and what learnings can be leveraged for the future. Speakers will also discuss the post-emergency declaration scenario, including what will happen with EUAs, what FDA has said thus far regarding EUA transitions, and why there is still a PHE for Zika and whether companies should be thinking about COVID in the same way.

 

Shelby Buettner, Principal Legal Counsel, Medtronic
Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors
Thomas J. Cosgrove, Partner, Covington & Burling LLP
Suzan Onel, Partner, Kleinfeld, Kaplan & Becker, LLP
Moderated by Derrick Gingery, Senior Writer, Informa Pharma Intelligence

Join speakers on an expedition into the patent-verse. This session will discuss the future of label carveouts for generics and biosimilar applicants as a way to avoid inducing patent infringement following the Federal Circuit’s 2021 GSK v. Teva decision. How will this decision impact the generic drug industry and affordability to patients? Is skinny labeling the only method to market a generic drug within the life cycle of an active patent? What impact, if any, does current caselaw on the skinny label have on generic competition?

 

Karin Hessler, Deputy General Counsel, Association for Accessible Medicine
Sara W. Koblitz, Director, Hyman, Phelps & McNamara, PC
Geoffrey M. Levitt, Of Counsel, DLA Piper LLP (US)
Jeremy Sharp, Managing Director, Waxman Strategies
Moderated by Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP

How has COVID-19 changed the diagnostics industry? What does the future of this field hold? How can entities increase access to better diagnostic tools to decrease health disparities? This session will discuss lessons learned from the shifting policies and flexibilities offered during the pandemic and the transition away from granting EUAs and toward full approval. Panelists will also discuss new innovations in diagnostics, technology certification pathways, and the future of the diagnostics regulatory structure with legislative changes pending in Congress.

 

William G. Morice, Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic
Mike Dobias, Officer, Health Care Products, The Pew Charitable Trusts
Timothy Stenzel, Director, Office of In Vitro Diagnostics and Radiological Health, CDRH
Moderated by Bethany Hills, Partner,  DLA Piper LLP (US)

Real-world evidence (RWE) and real-world data (RWD) are playing an increasing role in healthcare and by FDA to monitor products post-market, support regulatory decisions, develop guidelines, and support clinical and confirmatory trials. FDA has issued a number of guidance documents in this area, including four new guidances issued late last year, to further support RWE and RWD. During this panel, speakers will discuss these guidances and examine how RWE is used in patient-focused drug development and device clearances and approvals. Speakers will then delve further into circumstances where FDA has already used RWE in decision making, the importance for patients in utilizing this data, and how data can or should be utilized in the future.

 

John Concato, Associate Director, Real-World Evidence Analytics, Office of Medical Policy, CDER, FDA
Ryan Fischer, Chief Advocacy Officer, Parent Project Muscular Dystrophy
Jewell Martin, Associate Director for US Regulatory Policy, BioMarin Pharmaceutical Inc.
Moderated by Kristin Zielinski Duggan, Partner, Hogan Lovells US LLP

In April 2022, FDA proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and to prohibit all characterizing flavors–other than tobacco–in cigars. This panel will provide an overview of these proposed rules, discuss the definition of “characterizing flavor,” and address the potential intended and unintended impacts these product standards may have on public health. Speakers will also discuss how these standards fit into broader harm reduction efforts, considering the impact this may have on health equity, as well as vis-à-vis menthol- and mint-flavored ENDS.

 

Bryan M. Haynes, Partner, Troutman Pepper Hamilton Sanders LLP
Dennis Henigan, Vice President, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
Nicole L. Nollen, Professor, University of Kansas School of Medicine, Department of Population Health
John Pritchard, Vice President of Regulatory Science, 22nd Century Group, Inc.
Moderated by Beth G. Oliva, Partner, Fox Rothschild LLP

2:10–3:10 PM | Concurrent Breakout Sessions 6

During this session, FDA leadership will address the top issues CBER is facing as well as priorities and goals for the coming year.

 

Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA 
Moderated by Michael Werner, Partner, Holland & Knight LLP

The high cost of prescription drugs creates an enormous barrier to patient access and treatment. Last September, the Administration released a “Comprehensive Plan for Addressing High Drug Prices,” which focuses on increasing competition, including through the development and availability of generic drugs. This builds on FDA’s 2017 “Drug Competition Action Plan,” which has similar goals. This session will examine the current state of FDA’s actions, impacts on the generics industry, and current reforms that are expected to be included in the GDUFA, BsUFA, and other potential legislation, especially regarding 180-day exclusivity. Speakers will also consider Canada’s recent laws regarding drug pricing and the potential impact on the U.S. market.

 

Jeffrey K. Francer, Senior Vice President & General Counsel, Association for Accessible Medicines
Brian R. McCormick, Vice President, Chief Regulatory Counsel, TEVA Pharmaceuticals USA, Inc.
Eileen McMahon, Partner, Torys LLP
Moderated by Howard R. Sklamberg, Partner, Arnold & Porter LLP

Health care disparities have far-reaching consequences, especially when it comes to medical device or pharmaceutical development. This session will offer a legal, regulatory, and data-driven conversation about the future of medical product development and clinical trials, highlighting recent FDA guidance materials. It will explore how industry can reasonably improve diversity throughout product development, the role of FDA beyond guidance documents, and challenges facing both FDA and industry as we strive toward health equity. 

 

Maria Apostolaros, Senior Director, Science and Regulatory Advocacy, PhRMA
Jamie W. Gamerman, Regulatory Counsel, CDER, FDA
Kaveeta Vasisht, Associate Commissioner for Women’s Health, Office of Women’s Health, Office of the Commissioner, FDA
Madison Wheeler, Director of Technical Operations, EMMA International
Moderated by Winston S. Kirton, Partner, Winston & Strawn LLP

SaMD is changing how consumers manage their own health, how patients and providers interact, and even the practice of medicine. This panel will address FDA’s regulation of various types of digital health technology, providing an update on FDA guidance documents and priorities. Speakers will also discuss common challenges and key issues facing industry, including implementation of Good Machine Learning Practice (GMLP) and considerations on how to interact with FDA and submit a Predetermined Change Control Plan (PCCP).

 

Sonja Fulmer, Acting Deputy Director, Digital Health Center of Excellence, CDRH
Sonia W. Nath, Partner, Cooley LLP
Cassie Scherer, Director of Digital Health Policy and Regulatory Strategy, Global Regulatory Policy, Medtronic
Moderated by Kellie B. Combs, Partner, Ropes & Gray LLP

The food packaging industry is undergoing a transformation driven by sustainability and related truth in labeling initiatives.  This panel will discuss labeling activity at the state level and how federal law and reform initiatives may impact these state activities.  This panel also will address state activity regarding recycled plastic content mandates, federal responses, and resulting pressures on industry.

 

Joseph M. Dages, Associate, Steptoe & Johnson LLP
John Hewitt, Vice President, Packaging Sustainability, Consumer Brands Association
Mark Thompson, Partner, Keller and Heckman LLP

Recent legislation gave FDA explicit authority to regulate products containing synthetic and other non-tobacco derived nicotine (NTN) starting on April 14 of this year. The legislation also required manufacturers of NTN products to submit a PMTA by May 14, after which they can stay on the market through July 13 while awaiting an FDA decision. Panelists will discuss the unique problems posed by NTN products, why a legislative solution was needed, the ability of FDA to meet this deadline considering the number of other PMTA applications currently under review, and how FDA can or should approach enforcement against non-compliant products.

 

Tony Abboud, Executive Director, Vapor Technology Association
Michael Shane Benson, Compliance Counsel, Turning Point Brands, Inc.
William Jackson, Director R&D, Zanoprima Lifesciences Ltd.
Moderated by Scott Ballin, Health Policy Consultant

Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2021, and Cases to Watch, 2022.

 

Ralph F. Hall,  Adjunct Professor, University of Michigan Law School
Erika F. Lietzan, William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law, University of Missouri – Columbia School of Law
Ginger Heyman Pigott, Shareholder, Greenberg Traurig, LLP
Moderated by August T. Horvath, Partner, Foley Hoag LLP