Why Attend

Agenda

CLE

Tuesday, December 15

11:30 – 11:45 AM
FDLI Welcome and Introductions

Amy Comstock Rick, President & CEO, FDLI
Sonali P. Gunawardhana, Counsel, Shook, Hardy & Bacon LLP and Chair, 2020 Enforcement, Litigation, and Compliance Conference

11:45 AM –12:15 PM
Keynote Address

Daniel Feith, Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, US Department of Justice 

12:15–12:30 PM
Visit and Explore

Visit the lobby, sponsor booths, and learn about networking opportunities with fellow attendees during the conference.

12:30–2:15 PM
Compliance Central with FDA Center Compliance Directors: Part I – Presentations

Donald D. Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA
William A. Correll, Director, Office of Compliance, Center for Food Safety and Applied Nutrition, FDA
Swati Kabaria, Deputy Director, Office of Compliance and Enforcement, Center for Tobacco Products, FDA
Erin Keith, Associate Director, Compliance and Quality, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, FDA
Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA
Timothy C. Schell, Director, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA
Moderated by Daniel A. Kracov, Partner, Arnold & Porter LLP and Vice Chair, FDLI Board of Directors

This two-part session will address FDA’s top compliance issues, enforcement priorities, and goals for 2021. Hear directly from each FDA Center Compliance Director, learn how industry should focus its compliance efforts, and what to expect when you don’t follow FDA regulations.

2:20–2:50 PM
Compliance Central with FDA Center Compliance Directors: Part II – Q&A

The Center Compliance Directors will gather for a joint Q&A session. Submit your questions in advance, or live day of the session.

3:00–4:00 PM 
Concurrent Breakout Sessions

  • The Future of EUAs: What Happens Post-Crisis

Adrienne Franco Busby, Partner, Faegre Drinker Biddle & Reath LLP
Teresa Park, Of Counsel, Covington & Burling LLP
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC

The COVID-19 pandemic has spawned unprecedented regulatory flexibility via Emergency Use Authorizations (EUAs), the Public Readiness and Emergency Preparedness (PREP) Act Declaration for COVID-19, and regulatory guidance documents. During this session, speakers will discuss what types of activities spurred by the current pandemic might be subject to increased scrutiny in the post-COVID world, and the common misconceptions companies hold about these measures and their protections from enforcement, and what risks companies face in the form of product liability litigation for products allowed on the market under emergency use authorization.

  • Evolving Off-Label Enforcement Theories

Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Beth P. Weinman, Counsel, Ropes & Gray LLP

In the years since the Second Circuit’s decision in US v. Caronia, much has been said about the demise of the off-label promotion theory. However, a close examination reveals that DOJ and FDA continue to pursue promotional cases. DOJ has pursued a number of civil cases based upon a theory that the promotion involved false or misleading statements, which are not entitled to First Amendment protection. More recently, in the Avanir settlement, DOJ alleged that Avanir’s promotion caused the submission of claims that were for not medically accepted indications and therefore not eligible for payment by Medicare and Medicaid. This panel will examine the evolution of DOJ and FDA’s thinking in this space and consider how best to counsel clients in this evolving area.

  • Pandemic-Related Food Labeling Policies: What Has Changed and Will Any New Policies be Long-Term?

Sarah Sorscher, Deputy Director of Regulatory Affairs, Center for Science in the Public Interest
Ronald J. Levine, Independent Consultant, EAS Consulting Group LLC
Claudia A. Lewis, Partner, Venable LLP
Moderated by Suzie L. Trigg, Partner, Haynes and Boone LLP

The FDA has temporarily eased the policies on nutrition and menu labeling due to the COVID-19 pandemic. The changes allow for the sale of foods intended for restaurant use directly to retail consumers, and relaxed menu-labeling regulations. What are the potential negative effects from easing the policies? Should the changes be made permanent? Are there other food labeling-related policies that FDA should consider, either temporarily or long-term? What are some of the lessons learned from pandemic emergency guidance and policies?

  • The Premarket Tobacco Product Application Deadline Has Passed – What is the Current State of Enforcement?

Owen D. Chaput, Associate, Keller and Heckman LLP
Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP
Stacey Gagosian, Managing Director, Public Policy, Truth Initiative

Now that the September 9, 2020, deadline for premarket submissions for deemed products has come and gone, what has FDA’s tobacco enforcement looked like? What are the agency’s current enforcement priorities, and what impact has that had on both compliant and noncompliant industry? How demanding has FDA’s premarket review been, and what is the likelihood that the products currently on the market under FDA’s continued compliance policy will remain there? Explore this fascinating regulatory environment with our esteemed panel of experts.

4:15–5:15 PM 
Enforcement and Litigation Related to COVID-19

Daniel G. Jarcho, Partner, Alston & Bird LLP
Peter J. Leininger, Partner, King & Spalding LLP
William A. McConagha, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Moderated by Sonali P. Gunawardhana, Counsel, Shook, Hardy & Bacon LLP and Chair, 2020 Enforcement, Litigation, and Compliance Conference

Navigating the quickly evolving nature of the regulatory environment during and related to the COVID-19 pandemic has enhanced the potential risk of company exposure to enforcement activities, both for industry veterans and those who are new to the FDA-regulated space. This session would focus on FDA’s and DOJ’s recent enforcement activity related to the coronavirus pandemic, highlighting specific civil and criminal cases DOJ has initiated that could impact FDA-regulated companies. Panelists will discuss these cases, and  recent consent decrees, charging decisions, and fraud cases that are focused on CARES Act funding.

5:15–5:45 PM 
Daily Download
Join a Zoom group of your choice to network and discuss hot-button issues that were brought up during the day. Coffee or cocktail optional!

Wednesday, December 16

12:25 – 12:30 PM
FDLI Welcome
Laura Brown
, Director, Educational Programs, FDLI

12:30–1:00 PM
Address: Eighth Annual Eric M. Blumberg Memorial Lecture

John M. Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health, Inc.

1:05–2:05 PM
Global Supply Chains: Current Issues and Managing Risk

Stefanie Jill Fogel, Partner, DLA Piper LLP (US)

Jonathan Gil, Corporate Counsel, Pfizer, Inc.
Moderated by Howard R. Sklamberg, Partner, Arnold & Porter LLP

Even prior to the COVID-19 pandemic, pressures were building  to address vulnerabilities in supply chains across all FDA-regulated products. While the industries’ enormous contributions to the pandemic response have been lauded, the complexities and concerns emerging in the pandemic–including drug, device, food, and raw material shortages, challenges in rapid countermeasure development and deployment, and geopolitical/trade tensions–all point to a continued paradigm shift in the way governments and companies think about and regulate product supply chains. This panel will focus on new supply chain responsibilities for companies, FDA’s approach to enhancing supply chain quality and new supply chain risk management authorities under the CARES Act, and product development risks.

2:15–3:15 PM
Concurrent Breakout Sessions

  • FDA Inspections in the Age of COVID-19

Philip Crooker, Vice President – Technical, Parexel International Corporation
Stephanie M. Haggerty, Senior Corporate Counsel, Legal Division, Pfizer, Inc.
Anne K. Miller, Senior Principal Legal Counsel, Medtronic
Moderated by Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors

Given COVID-19 pandemic and restrictions, FDA announced early on that it was temporarily postponing most foreign and domestic inspections unless deemed “mission-critical.” As an expected result, the number of inspections has declined. What happened with inspections stopped? Has there been an impact on the domestic or foreign front from the gap in inspections? What are companies experiencing now that FDA is beginning to ramp back up inspections, or conducting virtual record reviews? This panel will explore FDA’s current approach to domestic and foreign inspections and explore options FDA may have to leverage virtual inspections both during the COVID-19 pandemic and beyond.

  • Digital Health: Enforcement, Regulations, and Risks

Christine P. Bump, Principal, Penn Avenue Law & Policy
Mahnu Davar, Partner, Arnold & Porter LLP
Fred Medick, Senior Corporate Counsel, Healthcare Law Group, Genentech, Inc.
Vernessa T. Pollard, Partner, McDermott Will & Emery LLP

Electronic health records (EHR), clinical decision support (CDS), and other digital health tools have become increasingly important to healthcare providers, yet FDA’s existing regulatory system is not designed to review, clear, approve, or otherwise respond to these technologies at the rate at which they develop and change. While many digital health products are currently subject to enforcement discretion, recent enforcement involving pharmaceutical manufacturer arrangements with EHR and CDS vendors has shed light on heightened risks and potential concerns associated with these activities. This panel will discuss the risks of relying on enforcement discretion long-term and potential regulatory strategy to combat this risk, recent enforcement against products and vendor arrangements, and compliance considerations while navigating this increasingly complex area.

  • Hot Button Issues and Trends in State and Local Government Tobacco Regulation and Enforcement

Beth G. Oliva, Partner, Fox Rothschild LLP
Agustin Rodriguez, Counsel, Troutman Pepper Hamilton Sanders LLP
Cheryl Sbarra, Executive Director and Senior Staff Attorney, Massachusetts Association of Health Boards
Kevin R.J. Schroth, Associate Professor, Department of Health Behavior, Society and Policy, Rutgers University School of Public Health

State and local governments have shown increased interest in tobacco and nicotine product regulation and litigation. Recent trends include flavor bans for some or all categories of products and states using consumer protection laws to file deceptive trade practices litigation against manufacturers. There have also been predictions that increased restriction of tobacco and nicotine products will result in a corresponding increase in black market activity, which local governments are typically tasked with combatting. This panel will discuss these trends and issues in light of FDA’s authority, the potential effectiveness and unintended consequences of such measures, and how companies can navigate a constantly evolving regulatory framework.

3:30–4:30 PM
Concurrent Breakout Sessions

  • Quality Risk Management (QRM) During a Pandemic and After: Essential Components of Risk Management During a Public Health Crisis

Barbara Allen, Senior Director, Global Quality External Engagement, Eli Lilly and Company
Dennis C. Gucciardo, Partner, Morgan, Lewis & Bockius LLP
Danielle Humphrey, Associate General Counsel, Regulatory Law and Compliance Office, Becton Dickinson
Frances Zipp, President & CEO, Lachman Consultants

During the pandemic, many global regulators identified opportunities for acceleration to speed vital products to market. In the US, this is being done using Emergency Use Authorizations for certain products. In order to meet market need during the crisis, there are certain Quality Risk Management issues that need to be considered by all members of the supply chain in order to assure that products that are produced for patients are of the highest quality. This panel will discuss what risk assessments need to be completed, from facility level through technical and operational risk assessment and others, in order to manufacture products at a high volume to meet market need without compromising quality. Speakers will also discuss various scenarios once the EUA is lifted and production moves into a steady state.

  • Regenerative Medicine: Policy, Innovation, and Risk Management for Emerging Technologies

Amy Garabedian, Associate General Counsel, Spark Therapeutics
Preeya Noronha Pinto
, Partner, King & Spalding LLP
Collin Stabler, Senior Associate, Exponent, Inc.
Julia C. Tierney, Chief of Staff, CBER, FDA

Development and growth of regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (HCT/Ps), gene-based therapies, and tissue engineered constructs, are forecast to expand considerably within the next five years. During this panel, speakers will discuss how FDA’s comprehensive regenerative medicine policy framework affects regulation of these new products, product innovation, and risk management in this burgeoning field, including considerations manufacturers should take in order to mitigate risk without stymieing innovation.

  • Other Agencies: FTC and SEC Litigation, Enforcement, and Application to FDA Authorities

Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission
Theodora (Teddy) McCormick, Partner, Epstein Becker Green, PC
William J. Stellmach, Partner, Willkie Farr & Gallagher LLP

4:35–5:30 PM
Top Trends and Cases in FDA and DOJ Criminal Enforcement

Hannah R. Bornstein, Partner, Nixon Peabody LLP
William F. Gould, Partner, Holland & Knight LLP
Steven A. Johnson, Vice President – Compliance & Legal Affairs, Zogenix, Inc.
Shannon Pedersen, Trial Attorney, Consumer Protection Branch, Department of Justice

The most powerful of FDA’s enforcement tools, criminal liability is generally thought to be, and often is, reserved for entities exhibiting willful disregard for the laws and regulations enforced by FDA. In the past 18 months, FDA, together with DOJ, has announced the resolution of a number of criminal actions against manufacturers. Some of these involve violations of the FDCA that, as described in the charging documents, do not appear to involve willful misconduct, while others do. Examining these resolutions together offers a timely reminder of the broad reach of FDA’s criminal authority and its willingness to pursue criminal cases where it perceives a significant risk to public health, including in cases that may not reflect the types of willful disregard generally associated with criminal resolutions.

5:30 PM
Closing Remarks and Adjournment