Enforcement, Litigation, and Compliance Conference
For the Drug, Medical Device, Food, and Tobacco Industries
December 7-8 | Washington, DC
FDLI’s annual Enforcement, Litigation, and Compliance Conference brings leading government regulators, attorneys, compliance officers, academics, and consultants together to discuss trends and issues in enforcement and compliance, the latest developments in both civil and criminal litigation, individual liability, and recent cases and settlements. This conference offers an opportunity to hear from and engage with top officials from FDA, DOJ, FTC, and other government agencies. New this year, we will be covering only intermediate and advanced topics; topics in food and tobacco law and regulation; and adding networking opportunities via roundtable discussions during lunch.
- Explore the trends behind increased enforcement actions
- Gain tips and best practices for responding to enforcement actions by FDA or other agencies
- Learn how to comply with new and upcoming FDA rules and regulations
- Identify what to do when FDA or another government agency shows up at your door for an inspection
- Understand the implications of the Yates memo on the FDA-regulated industry
- Address specific issues in food, drugs, biologics, medical devices, and tobacco
- Compliance Central with FDA Center Compliance Directors ( CDER, CBER, CFSAN, CTP, CVM)
- ORA and FDA District Directors Forum
- Criminal and Civil Enforcement: Protecting Your Company and Yourself
- International Enforcement and Compliance Issues
Industry & Firms
- +$400 for non-members
- +$200 for non-members
- +$200 for non-members
- +$100 for non-members
- +$100 for non-members
Enforcement, Litigation, and Compliance Conference
For the Pharmaceutical, Medical Device, Food, and Tobacco Industries
December 7-8, 2016
The Mayflower Hotel
1127 Connecticut Ave NW
Washington, DC 20001
*Agenda subject to change
Wednesday, December 7
8:00 – 8:45 AM
Registration and Continental Breakfast
8:45 – 8:50 AM
Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, Food and Drug Law Institute
8:50 – 9:20 AM
Benjamin C. Mizer, Principal Deputy Assistant Attorney General, Civil Division, Department of Justice
9:20 – 10:20 AM
Compliance Central with FDA Center Compliance Directors: Part I
This two part session will address FDA’s top compliance issues, enforcement priorities, and goals for 2017. Hear directly from each FDA Center Compliance Director and learn how industry should focus their compliance efforts, and what really happens when you don’t follow FDA regulations.
Tom Cosgrove, Acting Director, Office of Compliance, Center for Drug Evaluation and Research, FDA
Carl Fischer, Senior Advisor, Office of Compliance, Center for Devices and Radiological Health, FDA
Mary Malarkey, Director, Office of Compliance and Biologics Quality, Center for Biologics and Evaluation Research, FDA
Moderated by John R. Manthei, Partner, Latham & Watkins LLP
10:20 – 10:40 AM
10:40 – 11:40 AM
Compliance Central with FDA Center Compliance Directors: Part II
Daniel McChesney, Director, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA
Michael W. Roosevelt, Deputy Director, Office of Compliance, Center for Food Safety and Nutrition, FDA
Ann Simoneau, Director, Office of Compliance and Enforcement, Center for Tobacco Products, FDA
Moderated by Miriam Guggenheim, Partner, Covington & Burling LLP
11:45 – 12:30 PM
Concurrent Breakout Sessions in Your Industry
I. Food: Medical Foods: FDA’s Guidance, Substantiation Standards, and a Survey of Enforcement and Litigation Risk
This panel will focus on issues raised by FDA’s guidance on medical foods, including First Amendment concerns. Speakers will also discuss substantiation standards for medical foods, recent FDA warning letters, and the risk of class action litigation in the medical foods space.
William A. Garvin, Partner, Buchanan, Ingersoll & Rooney PC
Sarah Roller, Partner, Kelley Drye & Warren LLP
Moderated by Brooke Schumm, President and Principal, Daneker, McIntire, Schumm, Prince, Manning & Widmann, P.C.
II. Drugs and Device: False Claims Act Enforcement Targeting Drug and Device Companies
In June, the Supreme Court issued its opinion in Universal Health Services v. U.S. ex rel. Escobar, in which the Court affirmed the theory that violations of statutory and regulatory provisions can constitute actionable fraud under the False Claims Act. This panel will explore different views on how this decision might affect FCA investigations and litigation in the coming years, including whether the drug and device sectors can expect more cases based on violations of provisions of the Federal Food, Drug & Cosmetic Act.
Jonathan M. Phillips, Associate Attorney, Gibson, Dunn & Crutcher LLP
Robert L. Vogel, Partner, Vogel, Slade, & Goldstein, LLP
12:30 – 1:45 PM
Networking Luncheon with Roundtable Discussions
1:45 – 3:00 PM
Concurrent Breakout Sessions
Preparing for and Responding to FDA Enforcement Actions – Advanced Topics
I. Medical Products
This session will focus on policies and practices that companies should consider in preparing for the possibility of FDA enforcement action. The objective is to ensure that companies understand their rights and take appropriate action in response to FDA investigations, as well as how to address the potential culpability and defense of individuals who may be the subject of FDA enforcement.
Michael Beatrice, Principal, Validant
William F. Gould, Partner, Holland & Knight LLP
Daniel A. Kracov, Partner, Arnold & Porter LLP
Marta L. Villarraga, Principal, Exponent, Inc.
II. Food and Dietary Supplements
This session will address a company’s roles, rights, and responsibilities in the event of an FDA inspection or enforcement action. Speakers will also explore potential FDA enforcement actions given the multitude of new rules, regulations, and guidances released this year; FDA’s renewed interest in misbranding issues; and how to push back if you think FDA is wrong.
Allison Fulton, Partner, Sidley Austin LLP
Leslie T. Krasny, Partner, Keller and Heckman LLP
Alan G. Minsk, Partner, Arnall Golden Gregory LLP
Moderated by Stuart M. Pape, Shareholder, Polsinelli PC
3:00 – 3:20 PM
3:20 – 4:20 PM
Concurrent Breakout Sessions
Hot Topics in Your Industry
I. Food: Consumer Class-Actions and FDA Regulated Products
This panel will focus on topics such as: what products and claims are facing the greatest risk of class actions; follow-on litigation from FDA, FTC, and State AG enforcement actions, and strategies for reducing class action risk.
Jeffrey S. Jacobson, Partner, Kelley Drye & Warren LLP
Glenn G. Lammi, Chief Counsel, Legal Studies Division, Washington Legal Foundation
Yvonne M. McKenzie, Partner, Pepper Hamilton LLP
II. Drugs and Device: Warning Letters and Data Integrity
Recently, FDA has been issuing warning letters with language related to data integrity that appears to go beyond what is described in the draft guidance. Does this create a new cGMP standard for data integrity? This session will delve into the recent warning letters to address the GMP issue and determine what lessons can be learned.
Frederick R. Ball, Partner, Duane Morris LLP
Raj. D. Pai, Partner, Sidley Austin LLP
Robert A. Rhoades, Senior Vice President, QuintilesIMS
III. Tobacco: Interactions between the Deeming Rule and FDA Enforcement
FDA’s recently promulgated Deeming Regulations details FDA’s authority to regulate electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, and a number of other tobacco products that have been brought under its jurisdiction. This panel will discuss what to expect from FDA compliance inspections—including retail, internet, and import inspections, along with specific enforcement options. Learn more abou t FDA’s Center for Tobacco Products’ educational efforts to provide industry with compliance training and assistance.
David Dobbins, Chief Operation Officer, Government Affairs, Truth Initiative
Stacy Ehrlich, Partner, Kleinfield, Kaplan & Becker LLP
4:25 – 5:30 PM
Navigating FDA Import and Export Processes and Related Enforcement
This session will provide an overview of the laws, standards, and processes associated with the import and export of FDA-regulated products, with a particular emphasis on enforcement trends and processes for challenging detentions, alerts, and other enforcement actions.
John F. Johnson, Senior Associate Attorney, FDAImports.com LLC and Benjamin L. England & Associates, LLC
Douglas Stearn, Office of Enforcement and Import Operations, FDA
Domenic Veneziano, Independent Advisor for Import Operations, EAS Consulting Group LLC
5:30 – 7:00 PM
2016 Annual Holiday & Leadership Awards Reception
Thursday, December 8
8:00 – 8:30 AM
Registration and Continental Breakfast
FDLI Welcome and Remarks
8:30 – 9:30 AM
ORA and FDA District Directors Forum
Find out how district directors evaluate and handle issues in their jurisdictions.
Steven B. Barber, Director, Cincinnati District Office, FDA
Douglas Stearn, Office of Enforcement and Import Operations, FDA
Jessica Zeller, ORA Ombudsman, Office of Regulatory Affairs, FDA
Moderated by Steven Niedelman, Consultant, King & Spalding LLP
9:30 – 10:45 AM
Strict Liability Based on FDA Violations: How to Protect Your Company and Yourself
In July of 2016, two former J&J medical device unit executives were convicted of introducing a misbranded device into interstate commerce. This verdict comes on the heels of the Eighth Circuit’s July 2016 opinion upholding jail sentences for officers of Quality Egg LLC, who pled guilty to FDCA violations in connection with the sale of contaminated eggs. These convictions stem from the Responsible Corporate Officer Doctrine – otherwise known as the Park doctrine – under which officers and executives of food and drug companies can be held liable for FDCA violations even where they had no personal knowledge of wrongdoing. This session will explore recent government successes in obtaining criminal convictions under these theories, what factors make prosecution attractive, and what steps the food and drug industry can take to mitigate risk. Panelists will also explore how the Yates Memo factors into government prosecutions.
Daniel G. Jarcho, Partner, Alston & Bird LLP
Kevin B. Muhlendorf, Partner, Wiley Rein LLP
Neil F. O’Flaherty, Partner, Baker & McKenzie LLP
Moderated by Matthew T. Newcomer, Principal, Post & Schell, P.C.
10:45 – 11:00 AM
11:00 – 12:00 PM
Trends in Litigation
What are the most important cases and settlements of the past year that have stemmed from enforcement actions? Speakers will address cases in food, drugs, tobacco, and medical devices and how these cases set the tone for the future.
Adrienne Franco Busby, Partner, Faegre Baker Daniels LLP
Christopher M. Mikson, Partner, Mayer Brown LLP
Angela M. Spivey, Partner, McGuireWoods LLP
12:05 – 1:00 PM
Concurrent Breakout Sessions
I. Understanding and Responding to a State AG Inquiry or Investigation
A State Attorney General has a concern about a product you are selling or a claim you are making—will an AG file litigation or issue a subpoena right out of the gate? Likely not, but whether by phone, letter, or service of a Civil Investigative Demand (CID), an AG inquiry is concerning for a company. This session will address how to effectively respond to an AG inquiry no matter its form, define AG powers and authority, and how to avoid an inquiry in the first place.
Doreen L. Manchester, Counsel, Venable LLP
Ellyn L. Sternfield, Of Counsel, Mintz Levin Cohn Ferris Glovsky and Popeo PC
Philip Ziperman, Consumer Protection Director, Office of Attorney General for the District of Columbia
II. Limiting the Risk of Enforcement Actions following Acquisitions or Mergers
Many FDA enforcement actions stem from legacy systems and products acquired during mergers and acquisitions, such as via inadequate verification or validation activities. Adequate due diligence activities are crucial for the proper valuation of target companies and products, as well as to identify immediate compliance risks and avoid post-closure surprises. This session will address these issues and more, to ensure that acquired products meet the company’s and FDA standards, avoid FDA enforcement action, and mitigate litigation risk.
Neil P. DiSpirito, Of Counsel, Ballard Spahr LLP
Sandra C. Kalter, Vice President and Chief Regulatory Counsel, Medtronic
Natasha Leskovsek, Partner, Cooley LLP
Moderated by Danielle C. Humphrey, Senior Associate, Hogan Lovells LLP
1:00 – 2:00 PM
Luncheon Address: Fourth Annual Eric M. Blumberg Memorial Lecture
John R. Fleder, Director, Hyman, Phelps & McNamara, P.C.
Introduced by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher, & Flom LLP, and Member, FDLI Board of Directors
FREDERICK R. BALL is a partner at the law firm of Duane Morris LLP in Chicago, IL. He is vice-chair of Duane Morris’s White-Collar Government Regulatory Division of the Trial Practice Group, and heads its Pharmaceutical, Pharmacy, and Food Group. He focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil, and criminal matters with FDA, DEA, CMS, and other federal and state regulatory agencies. Mr. Ball helps generic pharmaceutical companies, biologics manufacturers, food companies (including supplement manufacturers), pharmacies, long-term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries, including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, fraud and abuse laws including labeling and advertising requirements. Mr. Ball also assists generic manufacturers bring products to market through patent analysis and Hatch-Waxman litigation. He is experienced in conducting internal investigations and advising companies on actions following the investigation. Finally, he helps companies maintain their trade secrets and competitive advantage through trade secrets litigation and enforcement of restrictive covenants. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financially and legally. In his spare time, he is an adjunct professor of law at DePaul University School of Law and serves on the FDLI Board of Directors. He is admitted to the Illinois State Bar, the Trial Bar of the U.S. District Court for the Northern District of Illinois, the Seventh Circuit, and the U.S. Supreme Court. A member of the American and Illinois State bar associations, Mr. Ball is a 1996 cum laude graduate of Cornell Law School and a graduate of the University of Colorado at Boulder.
STEVEN B. BARBER is the District Director of FDA’s Cincinnati District Office. In this position, he directs and manages the operations of the District Office. He is responsible for providing leadership and guidance to the district staff in the formulation, execution and oversight of the District’s enforcement actions and its response to emergencies, and for collaborating with other FDA offices, federal agencies, and FDA’s state and local partners. During his 26-year career with FDA, Steven has worked in 7 different field offices (Chicago, Kansas City, Florida, San Juan, Baltimore, Detroit, and Cincinnati). Within these districts, Steven has served in the laboratory as an analyst, as an investigator, as a compliance officer, and as district compliance branch director.
MICHAEL BEATRICE is principal at Validant. With 38 years of experience in both the public and private sectors working with pharmaceuticals, biologicals, nutritionals, medical devices, diagnostic, and biotechnology products, Mike Beatrice brings a wealth of insider knowledge and in-the-trenches experience to the Validant team. Prior to joining Validant, Mike spent 13 years as a Corporate Vice President at Abbott Laboratories, focusing on Quality and Regulatory. The three years prior to Abbott, Beatrice was a Vice President and a General Manager at Quintiles. Previously, Mike spent 21 at FDA and held various executive management positions, including three years as the Deputy Director of the Center for Biologics Evaluation and Research (CBER), and as Chemistry Division Director for the Office of Generic Drugs. Mike served on the Executive Advisory Council of The College of Integrated Science and Technology at James Madison University, the Board of Visitors at the University of Maryland, School of Pharmacy, and The Deans Advisory Council of the University of New Mexico, College of Pharmacy. He is a charter member of the Food and Drug Administration Alumni Association, and an active member of the Association of Food and Drug Officials. Beatrice earned a bachelor’s degree in pharmacy from the University of New Mexico, Albuquerque, and a master’s degree in pharmacy from the University of Oklahoma, Norman, and a PhD in pharmaceutics from the University of Maryland in Baltimore.
JENNIFER L. BRAGG is a partner at the law firm of Skadden, Arps, Slate, Meagher & Flom LLP in Washington, DC. Ms. Bragg is an experienced regulatory and litigation attorney, advising FDA-regulated companies, as well as hospitals and health care systems, facing government investigations and U.S. FDA enforcement challenges. Previously, Ms. Bragg served in FDA’s Office of Chief Counsel as associate chief counsel for enforcement, where she provided advice to FDA’s Office of Criminal Investigations. In addition to her thriving practice, Ms. Bragg is a member of the firm’s Women’s Initiatives Committee, which is designed to promote the retention and advancement of women in the firm.
LAURA A. BROWN is the Assistant Director of Educational Programs at the Food and Drug Law Institute (FDLI) in Washington, DC. She is responsible for closely monitoring and analyzing FDA laws, regulations, and guidance documents, case law, and new legislation to develop and implement conferences, educational programs, and webinars. Her main area of focus is on food safety, food advertising, labeling, litigation, and compliance. She also has experience in DOJ and FTC actions as they impact the FDA-regulated industries. Laura manages FDLI’s New to Food and Drug Law Group, which provides networking and educational opportunities to young professionals. Prior to joining FDLI, she worked as a legal intern and analyst for Spark Policy Institute in Denver, Colorado and was also a Legislative Fellow for Colorado Senator Irene Aguilar. Laura earned her JD from the University of Colorado Law School and her BA degrees in Ecosystem Science & Policy and Political Science from the University of Miami.
ADRIENNE FRANCO BUSBY is a partner at Faegre Baker Daniels. Adrienne is an experienced litigator in product liability, commercial, employment, class action and mass tort matters. As a member of the product liability group, she focuses her practice on drug and device litigation and represents local, national, and international manufacturers across the U.S. and in Canada. Adrienne is skilled in understanding and interpreting the science that affects complex drug and device product litigation. She plays a key role in strengthening clients’ cases by preparing expert witnesses in multiple disciplines including various medical specialties, biomechanics, metallurgy, human factors, epidemiology, environmental science, economics, vocational rehabilitation, and engineering. Adrienne also helps clients through pre-litigation counseling. Adrienne has extensive mediation and negotiation experience at all stages of litigation.
THOMAS COSGROVE is Acting Director of CDER’s Office of Compliance (OC). Mr. Cosgrove leads efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Mr. Cosgrove has led OC’s Office of Manufacturing Quality (OMQ), directing CDER’s compliance activities with respect to current good manufacturing practices (CGMP) and product quality. He also led OC’s Office of Unapproved Drugs and Labeling Compliance (OUDLC), where he was responsible for compliance divisions covering drug approval and labeling issues. Before coming to CDER, he worked in FDA’s Office of Chief Counsel as a litigator, was an attorney with Covington & Burling in Washington, DC, and clerked for Judge Catherine Blake on the United States District Court of the District of Maryland. Mr. Cosgrove holds a bachelor’s degree in psychology from Clark University in Worcester, Mass., a master’s degree in clinical psychology from New York University, and a JD from the University of Michigan Law School.
NEIL P. DISPIRITO is an attorney at Ballard Spahr LLP, and a member of the firm’s Business and Finance Department and its Life Sciences and Technology and Health Care Groups. He has more than two decades’ experience helping pharmaceutical, medical device, and life sciences clients comply with U.S. and international drug, biologic, and medical product regulation. His practice focuses on providing regulatory and enforcement counsel to companies of all sizes on products regulated by FDA. He has litigated against FDA and negotiated with its Office of General Counsel. He also handles licensing, patent and labeling issues, managed care issues, FDA enforcement defense and state enforcement matters, civil seizure claims, consent decrees, Medicare and Medicaid issues, and federal supply issues. Before becoming an attorney, Mr. DiSpirito worked as an executive for major pharmaceutical manufacturers in marketing, manufacturing, advertising, FDA regulatory and compliance, new drug approval, and worldwide business development. He also negotiated with regulatory authorities to launch products and manage them through the product life cycle. He also teaches pharmaceutical law at the Food and Drug Law Institute and to the FDA’s newly hired attorneys and reviewers.
DAVID DOBBINS is the Chief Operating Officer at Truth Initiative. Over the years, he has helped to develop the organization’s reputation as a leader both in tobacco regulatory practice and as a steadfast advocate for policies that increase health equity in tobacco control. He frequently represents the organization’s policy positions at conferences and in the press. Dave began working for Truth Initiative in 2002 as its associate general counsel. In this role, he helped with the successful defense of the organization against the Lorillard Tobacco Company’s effort to shut down the truth® youth smoking prevention campaign by claiming the ads “vilified” cigarette makers. Before joining Truth Initiative, he was part of the team that defended high-profile tobacco industry whistleblower Dr. Jeffrey Wigand from claims brought against him by the Brown & Williamson tobacco company. In short, Dave Dobbins is a leader who doesn’t shy away from taking on important causes when it’s to protect people’s lives.
STACY EHRLICH is a partner at Kleinfeld Kaplan & Becker LLP in Washington, DC. Her practice focuses on counseling and advocating on behalf of pharmaceutical, food, dietary supplement, tobacco, cosmetic, and medical device companies on a variety of matters involving FDA, USDA, and FTC, as well as state agencies. Ms. Ehrlich regularly speaks and writes on various food and drug law topics, including drug and cosmetic labeling and advertising, dietary supplement marketing, and nicotine and tobacco product regulation. She has authored chapters in the FDLI publications: Food and Drug Law & Regulation, How to Work with the FDA, and Top 20 Food and Drug Cases & Cases to Watch. Ms. Ehrlich currently serves on the Board of Directors of FDLI and has been named to Best Lawyers in America for FDA Law. She received her JD from Harvard Law School, cum laude, and her BA in English, magna cum laude, from Emory University.
CARL FISCHER is a senior advisor with FDA’s Center for Devices and Radiological Health, Office of Compliance, providing guidance on complex regulatory and scientific issues. Carl joined the FDA in 2009 as a biomedical engineer in the Office of Compliance’s Ob/Gyn, Gastroenterology & Urology Devices Branch. Since then, he has held various positions throughout FDA’s Office of Compliance, including Chief of General Hospital Devices Branch and Director of the Division of International Compliance Operations. He has broad experience with a wide variety of devices and combination products and has had extensive involvement with major FDA medical device cases and policy initiatives. Over the last few years he has been particularly involved in the evolution and implementation of the Medical Device Single Audit Program (MDSAP) at FDA. Carl received his BS in Biomedical Engineering from Johns Hopkins University and his MS and PhD in Biomedical Engineering from the University of Texas at Arlington and University of Texas Southwestern Medical Center joint program in Biomedical Engineering.
JOHN R. FLEDER is a director at Hyman, Phelps, & McNamara. He represents companies and individuals facing civil and/or criminal actions by the government on issues related to FDA, the FTC, the CPSC, and other federal agencies. He has more than 40 years’ experience, including almost 20 years personally prosecuting or supervising criminal and civil cases on behalf of these agencies, as well as later representing industry in private practice in those same types of actions. As a result, he provides insightful counsel and strategic guidance on regulatory matters, potential and actual litigation, and internal investigations concerning matters involving a number of federal agencies.
ALLISON FULTON is a partner in the Washington, DC office of Sidley Austin. She advises pharmaceutical, medical device, dietary supplement, and cosmetic companies in a variety of civil and regulatory matters. Allison’s areas of focus include assisting U.S. and international companies comply with current Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR). She regularly advises companies on preparing for FDA inspections, responding to FDA Form 483s and Warning Letters, remediating data integrity issues and handling adverse events and medical device reports (MDR). She works with companies throughout the world on GMP and QSR compliance, including the U.S., China, Europe, and South America. Allison also has led numerous internal investigations involving allegations of off-label promotion and healthcare fraud and abuse. Her practice includes advising clients on compliance issues, drafting healthcare compliance policies and procedures, and developing content for and conducting compliance training programs.
WILLIAM A. GARVIN is a shareholder with the firm of Buchanan Ingersoll & Rooney. William focuses his practice on issues related to the regulation and promotion of drugs, medical devices, dietary supplements, foods, and medical foods. He has extensive experience in assisting companies with complying and contesting administrative agency actions of the Food and Drug Administrations and the Federal Trade Commission. William is a Member of the Drugs and Biologics Committee for the Food and Drug Law Institute, a member of the Legal Advisory Council for the Natural Products Foundation, and a member of the Governmental Relations Committee for the American Herbal Products Association. William has also served as part of the Compliance Program Teams for both SupplySide West and Ingredient Marketplace.
WILLIAM F. GOULD is a partner in the Washington, DC office of Holland & Knight LLP. As a co-chair of Holland & Knight’s Health Care and Life Sciences team, Mr. Gould’s practice involves domestic and international enforcement defense with a focus on litigation and corporate compliance work on behalf of pharmaceutical and medical device companies. Mr. Gould’s recent engagements include litigation and internal investigations involving the False Claims Act, the Foreign Corrupt Practices Act, and the federal Anti-Kickback Statute. He also provides advice regarding risk management to companies in the health care sector. Mr. Gould currently holds a Top Secret/SCI level security clearance. Prior to returning to private practice, Mr. Gould was a federal prosecutor with the U.S. Department of Justice for over 10 years. From 2002-08, Mr. Gould was an Assistant U.S. Attorney and then a Managing Assistant U.S. Attorney in the U.S. Attorney’s Office for the Western District of Virginia. In addition, during that time Mr. Gould was appointed as a Special Assistant U.S. Attorney for two specially assigned investigations in the U.S. Attorney’s Offices in the District of Columbia and the Eastern District of Virginia. From 1997-2002, Mr. Gould was an Assistant U.S. Attorney in the U.S. Attorney’s Office for the District of Columbia. From 1999-2011, Mr. Gould was an adjunct professor of law at the University of Virginia School of Law. Prior to his government service, Mr. Gould was an associate with a multi-national law firm based in New York City. He also served as a law clerk for the Honorable Morton A. Brody, U.S. District Court Judge in the District of Maine.
MIRIAM GUGGENHEIM is a partner at Covington & Burling LLP and co-chair of the Food, Drug, and Device practice. Her practice focuses primarily on the food and dietary supplement industries. Ms. Guggenheim counsels clients in all aspects of food and dietary supplement development and marketing, from product formulation, manufacturing, and safety considerations to labeling and advertising. Her work for a broad range of leading global food and dietary supplement companies and major trade associations includes regulatory advice, advocacy before regulators, courts and legislative bodies, and strategic counseling in light of overarching public health and nutrition policy considerations. Ms. Guggenheim is ranked as one of America’s Leading Business Lawyers, Food & Beverages: Regulatory & Litigation by Chambers USA. Ms. Guggenheim received her BA, magna cum laude, from the University of Pennsylvania and her JD, with honors, from Columbia University School of Law.
DANIELLE C. HUMPHREY is a senior associate at Hogan Lovells. She advises clients on the U.S. Food and Drug Administration’s (FDA) regulation of medical devices and combination products, focusing on matters related to advertising and promotion, regulatory compliance, and premarket clearance and approval. A former Assistant General Counsel of Wal-Mart Stores, Inc., she uses her experience in the industry and firm grasp of medical device law and regulation to yield innovative and practical solutions for her clients. She analyses complex legal challenges and regulatory strategy for innovative products; prepares regulatory submissions; reviews print and web-based promotional and educational materials; and reviews and drafts standard operating procedures to drive regulatory compliance. Danielle also assists in the defense of criminal investigations by the U.S. Department of Justice, and in responding to FDA Warning Letters and Form 483s. She conducts regulatory due diligence and assists in negotiating corporate mergers and acquisitions and preparing initial public offerings.
JEFFREY S. JACOBSON is a litigation partner at Kelley Drye & Warren LLP and co-chair of the firm’s class action practice. He has 20 years of experience defending companies against consumer fraud and privacy-related class actions and advising them on compliance with federal and state consumer protection laws. From March 2014 until March 2016, Jeff served in executive positions in the New Jersey Attorney General’s Office and directed the State’s investigation of and enforcement against consumer protection violations. Jeff therefore has the unique perspective of having led both the defense and prosecution of alleged cases of consumer deception.
DANIEL G. JARCHO is a partner in the Litigation Department of Alston & Bird LLP in Washington, DC. His practice focuses on litigation involving the Food and Drug Administration and the industries that FDA regulates. He also counsels clients about resolving regulatory compliance disputes with FDA that could lead to litigation, including disputes over inspections, Form 483 observations, Warning Letters, recalls, and import alerts. Mr. Jarcho has represented clients in numerous FDA civil enforcement actions (for seizures, injunctions, and civil penalties) and in a wide variety of criminal investigations initiated by FDA. He also has significant experience representing clients in lawsuits challenging FDA regulatory actions under the Administrative Procedure Act. Mr. Jarcho previously served as a Trial Attorney in the U.S. Department of Justice’s Office of Consumer Litigation, where he represented FDA in federal court civil and criminal litigation, including enforcement actions for seizure and injunction, Administrative Procedure Act cases, and grand jury investigations. He is a graduate of Harvard College and Harvard Law School.
JOHN F. JOHNSON is an Associate Attorney at Benjamin L. England and Associates. His practice area focuses on representing industry before the FDA, particularly about import holds, detentions, refusals, import alerts, warning letters, and recalls. He also advises clients about regulatory compliance and developing business-sensitive solutions for exporting, importing, and distributing FDA regulated commodities. Johnson graduated from St. Mary’s College of Maryland and Washington College of Law at American University.
SANDRA C. KALTER is Vice President and Chief Regulatory Counsel at Medtronic, where she leads a team of legal regulatory experts in various areas of government regulation, including FDA law, import and export trade laws, environmental health and safety, advertising, promotion and social media, foundation law, and privacy. Prior to joining Medtronic, she practiced FDA law with King & Spalding for 13 years, with an emphasis on medical devices. Before joining King & Spalding, Ms. Kalter was with Weil, Gotshal & Manges in Washington, DC where her principal areas of practice were food and drug law, advertising, and consumer product safety. She received her BS in journalism from Northwestern University’s Medill School and her JD from The National Law Center of George Washington University. Ms. Kalter is a member of the District of Columbia Bar and the American Bar Association.
LESLIE T. KRASNY is a partner in the law firm of Keller and Heckman LLP, and manages the San Francisco office. Krasny joined Keller and Heckman in June 2001 and was instrumental in opening Keller and Heckman’s San Francisco office. Krasny practices in the areas of regulatory and administrative law, primarily focusing on food/dietary supplement and consumer product industry matters, including safety and labeling, recalls, ingredient evaluations/GRAS opinions, health-related claim substantiation, organic requirements, green/sustainability claims, advertising, California’s Proposition 65, recall insurance policies, continuing product guarantees, international trade, and biotechnology. She represents major food companies, from growers and manufacturers to retailers, and serves as General Counsel to the Produce Marketing Association. Krasny was Vice President and General Counsel of Dole Packaged Foods Company, and specialized in food and drug law in private practice prior to joining Keller and Heckman, San Francisco. She is a member of the Board of Directors of the Food and Drug Law Institute, serves on its Foods and Dietary Supplements Committee, and is on the Editorial Advisory Board of Food Processing Magazine. Krasny is a frequent speaker on food law at conferences and webinars. Prior to receiving her law degree, Krasny obtained a Masters in cell and molecular biology and worked in pharmacology research at the University of California, San Francisco and at Stanford University, School of Medicine. Her scientific background is valuable in working with clients and with Keller and Heckman’s scientific staff on legal matters involving technical complexity. Krasny was ranked by Chambers & Partners in the 2014 Edition of Chambers USA, America’s Leading Lawyers for Business and selected by U.S. News & World Report and Best Lawyers in the “Best Law Firms” 2014 list. Krasny is AV® PreeminentTM Rated by Martindale-Hubbell.
DANIEL A. KRACOV is a partner in Arnold & Porter’s Washington, DC office, where he co-chairs the firm’s Life Sciences & Healthcare practice. He helps life sciences manufacturers, trade associations and early-stage ventures negotiate challenges relating to the development, manufacturing, approval and promotion of drugs, biologics, medical devices, and diagnostics. In addition to day-to-day regulatory counseling, he regularly handles high stakes investigations and enforcement proceedings, the development of global compliance programs, and due diligence in financings, mergers, and acquisitions. He has a widely-recognized expertise in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislation.
GLENN G. LAMMI is Chief Counsel of the Washington Legal Foundation’s Legal Studies Division, a position he has held since January 1992. As Chief Counsel, Glenn coordinates legal policy advocacy and educational programs for the Foundation. In this capacity, he monitors legal-policy developments in federal and state courts, regulatory agencies, and legislatures, critically analyzing their impact on the free-enterprise system and the liberties of Americans as consumers, employees, and business owners. He oversees and writes regularly for WLF’s blog, the WLF Legal Pulse, and is a contributor to Forbes.com through Forbes’s WLF contributor site. Glenn also manages WLF’s multifaceted “Eating Away Our Freedoms” legal-policy campaign, which includes maintaining a robust social media presence through a dedicated website and Twitter feed. He graduated from American University’s Washington College of Law in 1991.
NATASHA LESKOVSEK is an FDA regulatory partner in the Life Sciences practice group at Cooley LLP and is resident in the Washington, DC office. Natasha advises regulated industry and its investors on strategic pathways to commercialization and pre- and postmarket compliance requirements. Prior to practicing law, Natasha worked as a clinical research nurse at NIH and in project management for a CRO. She received her JD from Georgetown University Law Center and BSN and MBA degrees from the University of Maryland.
TIRZA LOFGREEN is the Director of Educational Programs at the Food and Drug Law Institute (FDLI) where she provides senior leadership and oversight of FDLI’s educational events. She is an accomplished healthcare education and meetings executive with nearly 20 years of experience developing, marketing, and hosting cutting-edge programs and conferences domestically and internationally. In her current role, Tirza manages FDLI’s program planning and volunteer committees, and monitors and tracks regulatory developments in all FDA-regulated industries to ensure programming is timely and relevant. Her expertise is focused on educational programming for FDLI’s three largest events – the Annual Conference, Advertising & Promotion Conference, and Tobacco Conference. Tirza has held increasing roles in education working for the Association for the Advancement of Medical Instrumentation, Healthcare Distribution Alliance, American Pharmacists Association, and the Regulatory Affairs Professional Society. Tirza is a member of the American Society of Association Executives. She earned her BS in Health, Fitness, and Recreation Resources with a minor in Exercise Physiology from George Mason University. Tirza is also a Certified Health Education Specialist (CHES).
MARY MALARKEY is the Director of the Office of Compliance and Biologics Quality (OCBQ), Center for Biologics Evaluation and Research (CBER), FDA. Malarkey is responsible for managing, among other things, CBER’s surveillance, inspections and compliance programs, legal actions, bioresearch activities, advertising and promotional activities and aspects of biologics license application reviews. Before her current position, she was the Director in the Division of Case Management (DCM), OCBQ, CBER. Prior to that, Malarkey was a Branch Chief in the Division of Manufacturing and Product Quality (DMPQ), CBER. Prior to joining FDA in 1989, she worked in research and development in industry. She received a BS in Microbiology from the University of Maryland.
DOREEN L. MANCHESTER is a member of Venable’s Regulatory Group. She represents a variety of clients, including manufacturers of various foods and beverages, personal care and over-the-counter products, and dietary supplements. Ms. Manchester has significant experience representing clients in civil litigation, and state attorney general and other government investigations, and crafting legislative and public policy solutions to legal challenges. She also provides FDA, FTC, state attorney general, and NAD regulatory counseling and litigation support in labeling content matters, labeling and advertising claims, and other issues. Additionally, Ms. Manchester is experienced in labeling and advertising issues involving the use of health, nutrient content, structure/function, and disease claims. Ms. Manchester began her legal career as a law clerk with the Federal Tort Claims Act Office of the U.S. Department of Justice, working on medical malpractice and personal injury claims involving the Federal Tort Claims Act.
JOHN MANTHEI is the Global Co-chair of Latham’s Healthcare and Life Sciences Practice, specializes in regulatory matters involving the US Food and Drug Administration (FDA) for the medical device, pharmaceutical, and biotechnology industries. He advises clients on all aspects of the FDA-regulated product life cycle, post market enforcement, and administrative litigation. Mr. Manthei currently serves as outside FDA counsel to the Medical Device Manufacturers Association (MDMA), a member of the Food & Drug Law Institute (FDLI) Advisory Committee for Medical Devices, and a former member of the FDLI Advisory Committee for Drugs and Biologics. He previously served as Majority Counsel for the US House of Representatives’ Committee on Energy and Commerce (1998-2000). Mr. Manthei is recognized as a leading FDA attorney in industry publications such as Chambers USA (2010-2016) and The Legal 500 US (2012-2016). He has also been named a “Life Sciences Star” by Euromoney (2012-2016) and a “Top 40 Lawyers Under 40” by Washingtonian magazine (2006).
DANIEL McCHESNEY is the Director of the Office of Surveillance and Compliance in FDA’s Center for Veterinary Medicine. He has served in this position since October 2003. Prior to becoming the Director, he served as the Deputy Director for the Office of Surveillance and Compliance (1999-2003) and as the Acting Director of the Division of Compliance. His Office is responsible for developing and implementing surveillance and compliance policy concerning FDA regulatory responsibility with respect to animal drugs, feeds, food additives, veterinary medical devices, and other veterinary medical products. He joined FDA’s Center for Veterinary Medicine (CVM) as a microbiologist in 1990 and served as the Center’s expert on microbial contaminants of animal feed, and application of HACCP programs to the feed industry. He received a BS in Biology from Mercer University in Macon, Georgia and his MS and PhD in Cell and Molecular Biology from the Medical College of Georgia, Augusta, Georgia. Upon completing his degree, he entered the U.S. Army and was stationed at the Walter Reed Army Institute of Research (1978-1987) where he served as a research microbiologist. After completing his active military service, he was a senior investigator at the Armed Forces Radiobiology Research Institute responsible for determining the mechanism involved in increasing survival after radiation injury.
CHRISTOPHER M. MIKSON is a partner at Mayer Brown in Washington DC. Chris focuses his practice on regulatory, intellectual property, and other complex litigation and transactional matters involving health care and the life sciences. He has extensive experience in the regulation of food, drugs, biotechnology, and medical devices by FDA and other federal and state agencies. Chris has counseled and represented a wide range of clients in matters concerning product development, preclinical and clinical trials, premarket clearance and approval, citizen petitions, inspections, recalls, enforcement actions, and litigation under the Administrative Procedures Act. He has taught patent and FDA law at the University of Pennsylvania, and has spoken and written extensively on intellectual property and regulatory issues, including those concerning Hatch-Waxman, biosimilars, and medical devices.
ALAN G. MINSK is a partner and Chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP, located in Atlanta, Georgia, and Washington, DC. Prior to his association with AGG, he worked with a Washington, DC food and drug law firm. Mr. Minsk advises pharmaceutical, medical device, and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration, and certain matters concerning the U.S. Department of Agriculture, the Federal Trade Commission, the Drug Enforcement Administration, the Bureau of Alcohol, Tobacco and Firearms, and the Consumer Product Safety Commission. He counsels clients and has spoken and written on a wide variety of FDA-related issues, including regulatory strategies and life cycle management, combination products, FDA enforcement, FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports. He serves on the Editorial Advisory Boards of the RAPS Focus magazine, the Center for Communication Compliance, and the Law Journal Newsletters’ Product Liability Law & Strategy journals and serves on the University of Georgia College of Pharmacy Regulatory Affairs Advisory Board. Mr. Minsk was recently selected as Chambers USA: America’s Leading Lawyers in Life Sciences: Regulatory/Compliance and was selected for inclusion in the International Who’sWho of Life Sciences Lawyers 2013 and 2014. Nominees are selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. He serves on the Board of GaBio, the PDMA Alliance (as the General Counsel), and the Atlanta Jewish Academy. He is the former Georgia Chapter Leader of the Regulatory Affairs Professionals Society, and is also a member of the Food and Drug Law Institute, Conexx: America Israel Business Connector and serves on the External Advisory Board of the Atlantic Pediatric Device Consortium (APDC). He is a graduate of Brandeis University and Georgetown University Law Center.
BENJAMIN C. MIZER is Principal Deputy Assistant Attorney General. He oversees the largest litigating division in the Department of Justice. Prior to his appointment as the Principal Deputy Assistant Attorney General, Mr. Mizer served as Counselor to Attorney General Eric H. Holder, Jr., and as Deputy Assistant Attorney General in the Office of Legal Counsel at the Department. Before joining the Department, Mr. Mizer was the Solicitor General of Ohio. Earlier in his career, Mr. Mizer was as an associate in the Washington, DC, offices of WilmerHale and an associate legal officer at the International Criminal Tribunal for the Former Yugoslavia in The Hague, Netherlands. He was a law clerk for Justice John Paul Stevens of the United States Supreme Court and Judge Judith W. Rogers of the United States Court of Appeals for the DC Circuit. He is a graduate of the University of Michigan Law School and the College of Wooster.
KEVIN B. MUHLENDORF is a partner at Wiley Rein LLP. He represents clients in government investigations and enforcement actions involving securities fraud, health care fraud, defense procurement fraud, and the Foreign Corrupt Practices Act (FCPA). From 2010 until April of 2016, Mr. Muhlendorf was an Assistant Chief in the Fraud Section of the Criminal Division of the U.S. Department of Justice, and he previously served as Senior Counsel in the Enforcement Division of the U.S. Securities and Exchange Commission. In those roles, Mr. Muhlendorf routinely investigated and prosecuted cases involving securities fraud, bribery and public corruption, accounting fraud, benchmark rate fixing, insider trading, bank fraud, procurement fraud, the FCPA, and money laundering. He is an Adjunct Professor at Georgetown University Law Center where he teaches Complex Securities Investigations.
MATTHEW T. NEWCOMER is a principal in Post & Schell’s Internal Investigations & White Collar Defense Group, through which he collaborates with clients in a broad spectrum of industries including health care, pharmaceutical and medical device, as well as financial services, securities and government contracting. Mr. Newcomer conducts internal investigations and counsels and defends corporations, officers, and other individuals facing civil and criminal investigation, including matters involving multinational pharmaceutical and medical device companies and exposures concerning off-label sales and marketing practices, the Anti-Kickback Statute (AKS), the “Responsible Corporate Officer” or “Park” doctrine, the federal False Claims Act (FCA), and federal and state RICO statutes.
STEVEN NIEDELMAN is Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences practice team at King & Spalding, LLP, specializing in regulatory, enforcement, and policy matters involving industries regulated by the U.S. Food and Drug Administration where he provides strategic advice, insight, and guidance to the medical device, pharmaceutical, biologics, tobacco, and food industries. Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career where he served as Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He also served as the Director and Deputy Director of FDA’s Office of Enforcement, where he also presided as Chairman of FDA’s Compliance Policy Council. Before joining the Office of Enforcement, Mr. Niedelman spent nearly 24 years throughout the Office of Compliance at the Center for Devices and Radiological Health.
NEIL F. O’FLAHERTY is a partner in Baker & McKenzie’s Intellectual Property Practice Group in Washington, DC. He has over 25 years of experience involving FDA regulation of medical devices. Neil has spoken and written extensively on medical device and other FDA-related topics, including: the regulation of mobile medical apps and other medical software products; in vitro diagnostics; inspectional and enforcement authority; clinical trial requirements; device regulatory obligations of hospitals; and the impact of FDA law on business transactions and agreements. His practice also focuses on FDA regulation of human cellular and tissue-based products. Over the years, Neil has provided assistance to and collaborated with various medical device industry and health care groups, including providing guidance on device tracking, medical software, and device reclassification matters. Neil received his BA from the University of Notre Dame in 1987 and his JD from Loyola University of Chicago School of Law in 1990.
STUART M. PAPE is a shareholder and Head of the FDA Practice at Polsinelli PC. He is widely recognized as one of the country’s preeminent FDA lawyers. In his practice, he helps clients understand and face challenges presented by regulations imposed by FDA, USDA, state and local regulators, and similar health and safety regulatory bodies worldwide. He assists clients in obtaining approval of new food ingredients, pharmaceuticals, and medical devices; advises on labeling and advertising of regulated products; defends clients in enforcement proceedings initiated by regulatory bodies; and helps clients develop sound strategies in the face of challenges from NGOs. Mr. Pape served in various positions in the Office of the Chief of Counsel at the FDA, including as associate chief counsel for food as well as executive assistant to FDA Commissioner Donald Kennedy. Mr. Pape is a 1970 graduate of the University of Virginia and a 1973 graduate of its School of Law.
RAJ PAI is a partner in Sidley Austin’s Food, Drug and Medical Device Compliance and Enforcement practice. His practice focuses on representing life science companies in connection with government investigations, enforcement proceedings, and litigation. These investigations and enforcement proceedings involve a range of matters including marketing practices, product safety and reporting, good manufacturing practices, and civil and criminal violations of the FDCA, as well as violations of the False Claims Act. Prior to joining Sidley, Raj worked in the FDA’s Office of Chief Counsel. During his tenure, he worked closely with FDA’s Office of Criminal Investigations (OCI), the Department of Justice, and other federal agencies responsible for investigating, prosecuting, and resolving criminal and civil enforcement actions involving drugs, medical devices, and biological products. Raj has experience handling cases involving a wide array of issues, including marketing and promotional activities, reporting obligations, import issues, unapproved new drugs, adulterated foods, smuggling, and fraud.
JONATHAN M. PHILLIPS is an attorney in the Washington, DC office of Gibson, Dunn & Crutcher. As a member of Gibson Dunn’s FDA and Health Care practice group, his practice includes representing health care and life sciences clients in a range of government investigations and enforcement actions, including claims under the False Claims Act, the Anti-Kickback Statute, and the Federal Food, Drug, and Cosmetic Act. Prior to joining Gibson Dunn, Mr. Phillips served as a Trial Attorney in the U.S. Department of Justice’s Civil Fraud section, where he investigated and prosecuted allegations of fraud against the United States under the False Claims Act and related statutes.
ROBERT A. RHOADES is Senior Vice President, Quality & Compliance at QuintilesIMS. Within his over 30-year career, Rhoades has held a variety of leadership positions in quality management, counseling senior executives in FDA regulated companies regarding compliance and its impact on corporate performance and direction. His experience spans the quality discipline from managing the quality function at Baxter and Bausch & Lomb, to planning and implementing quality management and performance improvement systems for client companies around the world. He has led numerous compliance-related projects in the form of due diligence reviews for acquisition targets, the development of a complex corrective action plan which averted escalation of enforcement actions by the FDA, and the successful resolution of numerous warning letters, including those involving import detentions for foreign manufacturers. Rhoades has also worked in concert with client counsel on a wide variety of legal cases, and was recently selected by client counsel to assist in the worldwide heparin contamination investigation. He is frequently an invited speaker at pharmaceutical and medical device conferences in both the U.S. and EU, and has authored several articles on quality-related topics. His first book, Risky Business: Managing the Quality of America’s Medicines, was released by FDANews, and is now available as an updated Second Edition. A second book, Sustaining Compliance: Strategies for Maintaining Drug Quality, was released in 2005. Rhoades holds a BS in Microbiology from Purdue University and a MBA in Strategic Planning and Operations Management from Lake Forest (IL) Graduate School of Management.
AMY COMSTOCK RICK is the President and Chief Executive Officer of the Food and Drug Law Institute, having joined in August, 2014. Prior to joining FDLI, Ms. Rick was the Chief Executive Officer of the Parkinson’s Action Network (PAN) from 2003-2014. PAN is a Washington, DC-based national nonprofit focused on educating the public and government leaders on better policies for research and therapy development and an improved quality of life for people living with Parkinson’s disease. Ms. Rick has also served as the President of the Coalition for the Advancement of Medical Research, on the Boards of Directors of Research!America, the National Health Council, and the American Brain Coalition. Before joining PAN, she was the Senate-confirmed Director of the U.S. Office of Government Ethics from 2000-2003 and the Associate Counsel to the President in the White House Counsel’s Office from 1998-2000. Ms. Rick began her federal service as a career attorney at the U.S. Department of Education in 1989 and became the Assistant General Counsel for Ethics in 1993. Prior to her government service, Ms. Rick was an associate attorney at the law firm of Beveridge & Diamond. She received a Bachelor of Arts degree from Bard College and a Juris Doctor degree from the University of Michigan.
SARAH ROLLER is a partner in the Washington, DC office of Kelley Drye & Warren LLP and chair of the firm’s Food and Drug Law practice. For more than 25 years, Ms. Roller’s practice has focused on the representation of U.S. and global companies and industry trade organizations that are involved in the development, manufacture, labeling and marketing of foods, beverages, and health products. She represents companies in proceedings before FDA, USDA, FTC, TTB and state governmental bodies, and serves as counsel in litigation matters involving product safety, labeling and advertising regulation. Ms. Roller is a Registered Dietitian and received her Bachelor of Science from the University of Wisconsin-Madison and her Master of Public Health from the University of Minnesota. She received her Juris Doctor from The George Washington University. Ms. Roller has been recognized nationally as a leading practitioner by Chambers USA and selected as one of The Best Lawyers in America.
MICHAEL W. ROOSEVELT is the Deputy Director, Office of Compliance, in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). In this capacity, he provides leadership for food enforcement, compliance, and programmatic activities in FDA. During his over 24 years with FDA, Mr. Roosevelt has held several operational and management positions within CFSAN and FDA’s Office of Regulatory Affairs (ORA). He has nearly 10 years of field experience as an investigator in Florida District and a supervisory investigator in New Orleans District. Mr. Roosevelt has over 16 years of management experience with ORA and CFSAN as a field supervisor, Branch Director, Deputy Office Director, Acting Director for the Division of Seafood Safety (12 months), Acting Director for CFSAN’s Office of Compliance (26 months), and Acting Deputy Center Director for Operations (5 months). Mr. Roosevelt holds a Master of Public Management degree from the University of Maryland and a Bachelor of Science degree from the University of Florida. In February of 2010, he completed the 30-day residential program “Leadership for a Democratic Society” at the Federal Executive Institute (FEI) in Charlottesville, Virginia.
BROOKE SCHUMM is the President of Daneker, McIntire, Schumm, Prince, Manning & Widmann, PC in Baltimore, MD, a general practice law firm. Mr. Schumm’s involvement in food law and nutrition, diet supplements and medical food and related IP issues began as chair of the Subcommittee on Agricultural Finance of the ABA (1999-2003). He prosecutes patents in the pharmaceutical, chemical, and mechanical arts, and serves as outside general counsel for a diet supplement company, and as patent counsel for joint IP relationships with universities. He also handles commercial litigation, including trade secrets, in the mid-Atlantic area. Mr. Schumm is immediate past chair of the Patent Cooperation Treaty Issues Committee of the American Intellectual Property Law Association. He has served as the AIPLA delegate to the PCT Working Group in Geneva from 2012-2015. He is a member of the Attorney Peer Review Commission of Maryland. Mr. Schumm attended the University of Michigan Law School and holds a BS with distinction from the Cornell University College of Engineering. He is admitted to practice in Illinois (1980), California. Maryland and Florida and before the U.S. Patent and Trademark Office (1991).
ANN SIMONEAU is the Director of the Office of Compliance and Enforcement in the Center for Tobacco Products. Ms. Simoneau joined the agency in 2001 and has worked in FDA’s New England District Office, the Center for Drug Evaluation and Research’s (CDER) Division of Drug Marketing, Advertising, and Communications, and the Center for Devices and Radiological Health’s (CDRH) Office of Compliance. Prior to working for FDA, she was a practicing litigation attorney in Boston for several years. Ms. Simoneau has received a BS degree in pharmacy from Massachusetts College of Pharmacy, a JD degree from Boston University School of Law, and an MBA from Suffolk University, Sawyer Business School.
ANGELA M. SPIVEY is Managing Partner at McGuireWoods LLP Atlanta office. She defends and counsels food manufacturers, suppliers, distributors, and packaging entities on a host of issues, including implementation of recalls, defense of widespread international outbreaks and resulting civil litigation, defense of corporations and individuals in OCI criminal investigations, and regulatory oversight and compliance. Angela is a national speaker at various industry group conferences on a wide array of issues unique to the food industry. In addition to consulting with food-industry clients, Angela has first-chair trial experience before state and federal courts, matters ranging from product liability, personal injury, contract disputes, and business torts.
DOUGLAS STEARN is the Director of the Office of Enforcement and Import Operations in the U.S. Food and Drug Administration. The office is comprised of the Division of Import Operations, the Division of Enforcement, and the Division of Compliance Systems, which are the ORA headquarters units responsible for coordinating activities related to imports, compliance, recalls, and data systems. Mr. Stearn began this position in December 2013 after spending almost four years as the assistant director, and then the deputy director, of the Office of Compliance within FDA’s Center for Drug Evaluation and Research. Prior to joining CDER, Mr. Stearn was the director of the FDA’s Division of Compliance Policy for almost two years. Mr. Stearn received his undergraduate degree from Brown University in 1987. He received his law degree in 1991 from Cornell Law School. Immediately before joining FDA, Mr. Stearn worked as a trial attorney in the U.S. Department of Justice’s Office of Consumer Litigation for over fifteen years. In the course of his work at the Department of Justice, Mr. Stearn litigated numerous civil and criminal cases referred by FDA and other consumer protection agencies.
ELLYN L. STERNFIELD is of counsel with Mintz Levin’s Health Law Section, where she represents clients in federal and state healthcare investigations and cases; conducts internal investigations for clients regarding potential compliance issues; advises clients on business arrangements involving Medicaid, Medicare and the 340B Program; and mediates federal and state false claims act cases. Before joining Mintz, Ellyn spent more than 25 years as a government attorney, including stints as the Director of the Consumer Rights Division for the Utah Attorney General’s Office and as Director of the Oregon Attorney General’s Medicaid Fraud Control Unit, where she handled criminal and civil health care cases, including many brought as federal/state qui tam actions. She is a former president of the National Association of Medicaid Fraud Control Units (NAMFCU) and for 10 years served as co-chair of the NAMFCU Global Case Committee, where she developed the procedures used for handling national health care cases. Ellyn is a graduate of the Washington University School of Law and is a member of the DC, Missouri, Utah, and Oregon bars.
DOMENIC VENEZIANO is an Independent Advisor for Import Operations at EAS Consulting Group LLC. Mr. Veneziano is a veteran FDA specialist with over 24 years of Agency experience. He served as director of the FDA’s Division of Import Operations for more than ten years. In that role he was responsible for oversight of FDA’s import operations program and provided leadership, guidance, and direction to approximately 1,000 field investigators in more than 320 U.S. ports of entry. He also served as co-lead in the development of the FSMA import regulations and was senior advisor on the implementation of FSMA and the FDA Safety and Innovation Act. Mr. Veneziano began his FDA career in 1992 as a field investigator in the New England District specializing in medical device inspections. In 1998 he became a supervisory investigator in New England overseeing the medical device and import programs.
MARTA L. VILLARRAGA is a principal in Biomedical Engineering at Exponent, and is based in Philadelphia, PA. She has expertise in biomechanics and biomaterial-tissue interactions in medical devices, and evaluation of medical device performance during the premarketing and postmarketing stages. Dr. Villarraga has experience with orthopedic, spinal, plastic and reconstructive surgery, urology, urogynecology, general surgery, women’s health, and diagnostic medical devices. She has provided technical support for due diligence, regulatory submissions, regulatory compliance, risk management, postmarketing surveillance, product development, product liability, and intellectual property matters. As a Regulatory Affairs Certified (RAC) professional, Dr. Villarraga uses her knowledge of the U.S. FDA regulations to support identifying and justifying technical evaluations for premarket assessments or postmarket compliance matters. Dr. Villarraga has a PhD in Biomedical Engineering from Tulane University.
ROBERT L. VOGEL is the Founding Partner of Vogel, Slade, and Goldstein, LLP, a Washington, DC law firm that represents plaintiffs in qui tam cases involving health care, defense, and other kinds of procurement fraud. Before entering private practice, Mr. Vogel was a trial attorney in the commercial frauds section of the Department of Justice’s Civil Division. He has published more than a dozen articles, including “The False Claims Act and its Impact on Medical Practices,” Journal of Medical Practice Management, Vol. 26, No. 1 (July/August 2010); and “The 2009 Amendments to the FCA,” The Government Contractor, Vol. 51, No. 37 (October 2009). Mr. Vogel graduated from Amherst College and Stanford Law School, and he clerked for Judge Frank M. Johnson, Jr., of the U.S. Court of Appeals for the 11th Circuit. Mr. Vogel can be reached at (202) 537-5904, or by e-mail at [email protected].
JESSICA ZELLER is the ORA Ombudsman at the Food and Drug Administration, and has held this position since its inception in 2015. She is responsible for informally addressing concerns, complaints, and disputes arising between ORA and external parties, including industry, government entities (federal, state, territory, and tribal), and other members of the public. Ms. Zeller began her career at FDA in 2004 as a litigation attorney in the Office of Chief Counsel and subsequently was the Deputy Director of the Office of Compliance and Enforcement at FDA’s Center for Tobacco Products. Before returning to FDA as ORA Ombudsman, Ms. Zeller spent 2 years as lead FDA attorney for Procter and Gamble. She holds a BS from Xavier University, and JD and MA degrees from the University of Virginia.
PHILIP ZIPERMAN is the Director of DC Attorney General Karl Racine’s Office of Consumer Protection. As the Director, Philip oversees the legislative, consumer education, and enforcement activities of the Office of Consumer Protection. The Office investigates violations of District of Columbia consumer laws including, but not limited to, matters involving debt collection, credit counseling agencies, credit repair companies, debt settlement companies, foreclosure assistance providers, health product retailers, property management groups, the consumer credit industry, auto repair facilities, auto finance, Internet auctioneers, home builders, home improvement contractors, pharmaceutical companies, household goods movers and privacy. Philip has led national efforts to reform the debt relief and debt collection industries. Formerly, Philip served as the Deputy Chief with the Maryland Attorney General’s Consumer Protection Division. Philip also managed the Maryland Attorney General’s Privacy Unit, which monitored compliance with state and federal privacy and consumer protection laws, investigated businesses that fail to protect consumers’ personal information, and educated the public on privacy matters. Prior to his public service, Philip practiced law in Maryland and the District of Columbia litigating medical malpractice and toxic tort cases. Philip is a 1990 graduate of the Washington College of Law at the American University.
- FDA’s Revised Medical-Foods Policy Impedes Care and Violates the First Amendment
- Medical Foods Case Law
Speaker Slides – Wednesday, December 7
- Compliance Central with FDA Center Compliance Directors: Part I
- Compliance Central with FDA Center Compliance Directors: Part II
- Drugs and Device: False Claims Act Enforcement Targeting Drug and Device Companies
- FDA’s Guidance, Substantiation Standards, and a Survey of Enforcement and Litigation Risk
- Preparing for and Responding to FDA Enforcement Actions: Food Inspections, Recalls and Enforcement Actions
- Issues: Food Inspections, Recalls and Enforcement Actions
- Preparing for and Responding to FDA Enforcement Actions – Advance Topics: Food and Dietary Supplements
- Preparing for and Responding to FDA Enforcement Actions: Medical Products
- Food: Consumer Class – Actions and FDA Regulated Products
- Drug and Device: Warning Letters and Data Integrity
- Food: Consumer Class – Actions and FDA Regulated Products
Speaker Slides – Thursday, December 8
Continuing Legal Education
Continuing Legal Education credits will be awarded for attending this program.
FDLI applies directly to Ohio, Pennsylvania, and Virginia. New York recognizes Pennsylvania approvals. These states are generally recognized as approved jurisdictions by other states, however, each state bar has its own requirements, and it is the responsibility of the attorney seeking CLEs to know and fulfill such requirements. Please contact your Bar Association for guidance.
Virginia, Pennsylvania, and Ohio approvals are pending.
FDLI applies for CLE credits prior to each meeting but sometimes the approval is not granted until after the meeting. As approvals are received, updated CLE information will be posted here, and you can request to be notified.
Location and Overnight Accommodations
The Mayflower Hotel
1127 Connecticut Ave NW
Washington, DC 20036
Overnight Accommodations: Rooms are available at a discounted rate of $299 a night through November 4, 2016. After that date, rates and availability may vary.
Business attire is recommended and some meeting rooms may have cooler temperatures.
Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.