Agenda & Speakers Slides

Day 1: Agenda & Speaker Slides
Day 2: Agenda & Speakers Slides
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Thursday, December 12

8:00 – 9:00 AM 

As an attorney, what are your obligations when advising and counseling a company during the process of an internal investigation? What information is privileged, and is there information that will be in your client’s best interest to disclose? During this panel, speakers will discuss ethical issues attorneys must consider during internal investigations and how best to handle issues that arise.

John T. Bentivoglio, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
William Gould, Partner, Holland & Knight LLP

8:30 – 9:10 AM 

Registration and Continental Breakfast

9:10 – 9:15 AM 

FDLI Welcome and Remarks
Laura Brown, Director, Educational Programs, Food and Drug Law Institute

9:15 – 9:45 AM 

Keynote Address
Stacy Cline Amin, Chief Counsel, FDA

9:45 – 10:45 AM

What are the top litigation and enforcement trends impacting companies? During this session, panelists will address enforcement trends and emerging areas of government focus that are important to consider when developing a compliance strategy and navigating the demanding regulatory regimes for FDA-regulated companies. Speakers will also address False Claims Act liability post-Escobar, where regulatory non-compliance can lead to False Claims Act liability, and DOJ’s recent Guidance on cooperation credit in False Claims Act matters.

Hannah R. Bornstein, Partner, Nixon Peabody LLP
Lauren Misztal, Associate General Counsel, Legal Investigations, Mallinckrodt Pharmaceuticals
Jonathan M. Phillips, Partner, Gibson, Dunn & Crutcher LLP
Moderated by Michael Paddock, Partner, Sheppard Mullin Richter & Hampton LLP

10:45 – 11:00 AM

Coffee and Networking Break

11:00 – 11:55 AM 

Concurrent Breakout Sessions:

The FD&C Act does not include a private right of action — only the Agency can enforce FDA law and regulations. Traditionally, courts have been reluctant to entertain private lawsuits under the Lanham Act and unfair trade practice laws as a back door to enforcing FDA laws. However, a recent court ruling in POM Wonderful v. Coca Cola has changed the Lanham Act landscape, opening the door to private lawsuits for unfair competition related to FDA, particularly related to unfair competition from unapproved products, dietary supplements, compounded products, off-label promotion, and even counterfeiters and diverters. Hear from experts on what POM Wonderful and subsequent cases mean for industry, and how these cases are shaping FDA policy and enforcement actions.

Lisa M. Dwyer, Partner, King & Spalding LLP
Charles N. Jolly, Of Counsel, Baker Donelson
Moderated by John Claud, Assistant Director, Consumer Protection Branch, US Department of Justice

The US market has been flooded with CBD products since the 2018 Farm Act was signed into law on December 20, 2018, but with no federal regulations concerning the manufacturing, marketing, or sale of CBD and CBD-containing products, we look to the only official guidance issued thus far: warning letters and state actions. Marketing CBD products for therapeutic purposes online has been at the core of these warning letters, but what does that mean for CBD products that do not include therapeutic claims? This panel will discuss the most recent warning letters, address enforcement actions at the state level, analyze the potential for increased enforcement in this area, discuss enforcement priorities for products making egregious claims, and brainstorm how CBD manufacturers can remain “compliant” in this uncertain regulatory environment.

Frederick (Rick) Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, FTC
Aaron Negangard, Chief Deputy Attorney General, Indiana
Moderated by Libby Baney, Partner, Faegre Baker Daniels LLP

This session will feature a round-up of recent court decisions, pending cases, and state and federal enforcement actions that either have or likely will impact the tobacco and nicotine products industry. Topics will include: litigation to postpone or remove the May 12, 2020 premarket application deadline; state and private litigation against ENDS manufacturers; federal and state efforts to ban flavors; and a discussion of recent FDA warning letters.

Benneville (Ben) Haas, Partner, Latham & Watkins LLP
Eric Heyer, Partner, Thompson Hine LLP

11:55 AM – 12:00 PM

Transition

12:00 – 1:00 PM

Concurrent Breakout Sessions:

In litigation challenging FDA actions under the Administrative Procedure Act, courts have long deferred to FDA’s interpretation of its own regulations, which means in practice, the agency almost always prevails. Recently, the Supreme Court revisited this deference doctrine in the case Kisor v. Wilkie. Although the Court did not invalidate the doctrine it did articulate numerous restrictions on judicial deference. These restrictions could affect the outcome of future litigation challenging FDA actions by increasing the situations in which courts may invalidate FDA’s interpretation of its own regulations. The panel will discuss the potential implications of Kisor v. Wilkie.

Charles Biro, Trial Attorney, Consumer Protection Branch, US Department of Justice
Daniel Jarcho, Partner, Alston & Bird LLP
Moderated by James N. Czaban, Partner, DLA Piper LLP

This panel will take a practical look at issues companies face while importing FDA-regulated commodities into the US. After a short introduction to the import process, panelists will discuss and offer insight on issues including: prior notice, import orders  and the differences between import alerts (IA) and import bulletins (IB), FSMA’s FSVP, third party certification of high-risk foods, suspension of registration, and the differences between importing diverse commodities.

Desmond Brown, Division of Food Defense Targeting, ORA, FDA
Ted Poplawski, Special Assistant, Division of Import Operations, ORA, FDA
Angel Suarez, Independent Consultant, EAS Consulting Group LLC
Moderated by Robert Durkin, Of Counsel, Arnall Golden Gregory LLP

FDA has estimated that it has received more than 800 cell and gene therapy INDs, with 200 more expected yearly by 2020. Companies developing these innovative products face many challenges during product development through approval and commercial marketing. This panel will discuss several critical compliance and enforcement challenges facing cell and gene therapy companies, such as: the status of recent stem cell compliance and enforcement actions and pending litigation and whether FDA poised to take more action at the end of the enforcement discretion period next year to further define 351 vs. 361 products; and compliance challenges during the clinical study phase, including transitioning from clinical to commercial manufacturing. What can companies learn from pending actions against Novartis/Avexis for data manipulation? Are there other compliance concerns?

Perham Gorji, Deputy Chief Counsel for Litigation, Office of the Commissioner, FDA
Katie Laney, Principal Consultant, Validant
Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA
Moderated by Kalah Auchincloss, Senior Vice President, Regulatory Compliance & Deputy General Counsel, Greenleaf Health, Inc.

1:00 – 2:15 PM

Luncheon Address: Seventh Annual Eric M. Blumberg Memorial Lecture
Richard M. Cooper, Senior Counsel, Williams & Connolly

2:15 PM

Conference Adjournment