Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries
December 10–11, 2024 In-Person Event
Preliminary Agenda
Agenda Subject to Change
All Times Listed in Eastern Time
To view the session description, please click on the session title.
Tuesday, December 10
FDLI Welcome and Opening Remarks
Christine M. Simmon, President & CEO, Food and Drug Law Institute
Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Keynote Address
Burden Walker, Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, U.S. Department of Justice
This session will address FDA’s top compliance issues, enforcement priorities, the reorganization of the Office of Regulatory Affairs (ORA), and goals for 2025. Hear directly from each FDA Center Compliance Director, learn how industry should focus its compliance efforts, and understand the consequences of not following FDA regulations.
Jill Furman, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA (Invited)
Keisha Thomas, Associate Director for 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
Ann M. Oxenham, Director, Office of Compliance, Center for Food Safety and Applied Nutrition, FDA (Invited)
John Verbeten, Director, Office of Compliance and Enforcement, Center for Tobacco Products, FDA
Timothy C. Schell, Director, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA (Invited)
Moderated by Perham Gorji, Partner, DLA Piper LLP (US)
11:00–11:20 AM | Networking Break
11:20 AM–12:20 PM | Concurrent Breakout Sessions 1
The last decade has seen sweeping challenges to agency actions that have significantly affected how they regulate, culminating with the Supreme Court’s decision in Loper Bright that overruled the Court’s landmark 1984 Chevron decision. As Loper Bright has already been invoked by FDA in its opening brief in the Wages and White Lions case at the Supreme Court, and by plaintiffs challenging FDA’s regulation of laboratory developed tests, the discussion will cover both the possible near-term effects of Loper Bright and its future effect on FDA enforcement and compliance activity.
This panel will survey recent notable developments in enforcement activity involving both traditional medical devices and digital health technologies and consider what warning letters to these industries may suggest for areas of potential future enforcement. Panelists also will examine recent criminal enforcement matters involving medical device companies and their executives, including the underlying charging theories and efforts by DOJ to use corporate monitors to oversee GMP/QSR compliance as part of Deferred Prosecution Agreement resolutions.
The clinical research industry is evolving at a rapid pace, increasingly incorporating decentralized elements, such as the use of telehealth visits and local health care providers to perform trial-related activities at nontraditional sites. Digital health technologies are revolutionizing data collection, making it possible to acquire data remotely from clinical trial subjects across geographic regions. This session will examine recent trends in FDA and DOJ oversight and enforcement of clinical research and will consider the impact that industry modernization may have on such efforts going forward. The panel will also consider best practices for sponsors, CROs, and other industry members to ensure both data integrity and subject protection in this evolving landscape.
12:30–1:30 PM | Networking Luncheon
1:30–2:30 PM | Concurrent Breakout Sessions 2
FDA applies its enforcement discretion to many of the industries it regulates, including in ways that may go beyond applications of enforcement discretion by other federal entities. This panel will explore examples of FDA’s enforcement discretion policies, including around human cells, tissues, or cellular or tissue-based products and laboratory developed tests, and how these policies may allow the Agency to manage its limited resources while also leaving FDA vulnerable to administrative and judicial challenges. The panelists will discuss the development and implementation of these policies, the reactions of regulated industries, and judicial review of the Agency’s exercise of enforcement discretion.
On May 6, 2024, FDA finalized a long-awaited rule setting forth a phased approach for regulating LDTs as medical devices. One of FDA’s key goals of the regulation was to level the playing field between tests regulated as IVDs and those offered as LDTs. The LDT final rule is now under legal challenge, making the compliance and enforcement environment even more uncertain. This session will discuss FDA’s regulatory approach to LDTs, and how to prepare for and comply with the phased-in requirements. Panelists will also address the recent lawsuits and the bases for the challenges under the Administrative Procedure Act (APA), as well as the potential outcomes, and discuss the enforcement risk that companies may face in the current environment.
In June of this year, the Senate Judiciary Committee held a hearing on Combating the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes. In that same timeframe, FDA and the Department of Justice announced the creation of a federal multi-agency task force intended to curb the distribution and sale of illegal e-cigarette products responsible for nicotine addiction among youth. Speakers will discuss the current state of the illicit e-cigarette market, consider the ways in which the multi-agency federal task force, its constituent parts, and the states have addressed (and should address going forward) illicit e-cigarette distribution, and evaluate the extent to which additional statutory or regulatory authority is needed to augment enforcement efforts. Speakers will also consider in what ways, if any, the U.S. tobacco industry can contribute to the overall effort to combat youth vaping.
2:30–2:45 PM | Networking Break
2:45–3:45 PM | Concurrent Breakout Sessions 3
After significant recall activity and use of its statutory authorities to require a manufacturer to “repair, replace, or refund” a medical device, FDA entered into a consent decree with Phillips that included a number of noteworthy aspects. This session will explore this decree, the underlying circumstances behind it, and its potential implications for industry as it seeks to learn from and adapt its compliance strategies to this new development. The session will also explore other significant QSR enforcement trends, including recent design-related recalls.
In FY 2024, the number of FDA Warning Letters continued to increase to pre-COVID rates. In this session, panelists will analyze common root causes of drug shortages, senior management’s obligation to conduct effective oversight of quality and operations, and how to prevent or address the distribution of adulterated product in interstate commerce while at the same time avoiding drug shortages. Panelists will also discuss when to continue manufacturing or halt production, how to engage effectively with FDA, and additional guidance that would help industry to prevent or mitigate drug shortages while addressing critical compliance challenges. Industry attendees will gain valuable insight on domestic and international enforcement trends, and proven strategies for communicating with the agency about compliance challenges or potential supply chain interruptions.
The passage of the Modernization of Cosmetics Regulations Act (MoCRA) in 2022 put a new regulatory focus on the safety of cosmetics and personal care products. Speakers will also explore what’s changed since MoCRA was first enacted, what hasn’t, and what additional rulemaking obligations remain. This session will discuss how industry stakeholders can prepare for FDA’s continued rollout of MoCRA, to include takeaways from the first mandatory facility registration and product listing deadline for cosmetic products, discussion of FDA’s proposed GMPs for cosmetics, and best practices for developing responsive regulatory policies to manage records and data about adverse events and possible recalls. The panel will also provide guidance on preparing for inspections as FDA identifies and develops its enforcement priorities.
PFAS substances have been the subject of great discussion as “forever” chemicals due to their inability to degrade easily. Because exposure to some types of PFAS have been linked to serious health effects, FDA has been working to better understand PFAS in foods. Meanwhile, litigation over exposure to PFAS has been brought through litigation, from California’s Proposition 65 to class actions under state tort and environmental laws. Panelists will discuss the history of PFAS in food and food contact materials, what FDA is doing about it, state efforts to regulate PFAS, industry concerns over compliance, and lessons learned from litigation over PFAS.
3:45–4:10 PM | Networking Break
Recent years have seen increased discussion of the evolving roles of various government agencies – including FDA, DOJ, FTC, and HHS-OIG – in enforcement matters involving FDA-regulated products. In this session, leaders from key consumer protection agencies will discuss their respective enforcement priorities and the role of inter-agency cooperation in consumer protection matters. The panel will also address current hot topics such as the inclusion of forward-looking compliance provisions in consent decrees, DPAs/NPAs, and CIAs, and overlapping enforcement jurisdiction in digital health and other developing areas.
5:15–7:30 PM | FDLI 2024 Annual Holiday Reception
Wednesday, December 11
Highly publicized FDA/DOJ enforcement cases can create long-lasting legal precedents impacting industry business strategies as well as public health. Panelists will share overviews of and insights into this year’s most significant current litigation, plus cases to watch in the coming year.
10:15–10:30 AM | Networking Break
What will FDA enforcement look like under the new administration? In this session, panelists will discuss the implications of the U.S. presidential and congressional elections, with a particular focus on the scope of FDA’s authority and FDA’s compliance and enforcement activities. Panelists will consider how the agency in a new administration may prioritize enforcement, work to reduce the foreign inspection backlog, and collaborate with other Federal entities. The panel will also provide its political and policy predictions for 2025 and beyond.
11:30–11:45 AM | Networking Break
11:45–12:45 PM | Concurrent Breakout Sessions 4
FDA increasingly expects or requires companies to employ independent technical consultants in responding to FDA Form 483s and Warning Letters. Consultants may help prepare for pre-approval and post-market inspections and to audit potential merger or acquisition targets. They also may certify compliance of released products, assess the risk of marketed products, evaluate compliance with current Good Manufacturing and Good Clinical Practices, and assess data integrity. In many cases, companies’ counsel manages the consultant’s work to preserve privilege. This panel will discuss the role of consultants and lawyers in these engagements, establishing the scope of the consultants’ work, protecting the privilege, and a company’s potential reporting obligations to FDA and the Department of Justice.
Over the last decade, FDA has issued several draft and final guidance documents related to cybersecurity, and Congress has begun to legislate additional requirements as the observed risk of cyberattacks has grown. While some companies have implemented policies and processes to address these issues, many questions remain around risks in both pre- and post-market situations. This session will focus on the compliance and enforcement risks, both observed and potential, based on cyber vulnerabilities. Speakers will also explore FDA requirements with respect to a cybersecurity data breach incident.
FDA established Human Foods Program on October 1st. The move follows the findings and recommendations of the Reagan-Udall Foundation expert panel and is designed to enhance FDA’s ability to oversee the human food supply as well as other products the agency regulates. Panelists will cover the organization and structure of the HFP, and the new Office of Inspections and Investigations, and what industry and stakeholders can expect moving forward.
In this session, panelists will discuss the active landscape of tobacco litigation. Panelists will focus on the FDA v. Wages and White Lion case currently before the Supreme Court and its potentially significant implications for FDA’s review of tobacco and nicotine product applications, in particular, as well as for therapeutic products like drugs and devices, in general. Speakers will also discuss the graphic warnings and premium cigar litigations, and more.
Vernessa Pollard, Partner, DLA Piper LLP and Vice-Chair, FDLI Board of Directors
2:00 PM | Conference Adjournment