In this program, speakers will discuss how FDA collaborates and intersects with other government agencies such as USDA, FTC, DOJ, and EPA to enforce laws and regulations related to food, drugs, dietary supplements, tobacco, and medical devices to ensure they are safe.
A reception will follow to meet the speakers and mix and mingle with your fellow NFLR members.
Speakers
Stacy Cline Amin, Partner, Morrison & Foerster LLP
John Claud, Counsel, Hyman, Phelps & McNamara, PC
Brian Sylvester, Special Counsel, Covington & Burling LLP
Moderated by Jae Kim, Senior Associate, DLA Piper LLP
STACY CLINE AMIN co-leads the FDA Regulatory & Compliance practice at Morrison Foerster and provides strategic regulatory and business advice to companies in the life sciences, healthcare, food, and technology industries. Stacy previously served as Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS). She worked closely with agency leadership to resolve challenging legal and regulatory issues, and was part of the leadership team that conceived of and launched FDA’s ‘New Era of Smarter Food Safety,’ which outlines the use of new technologies like AI/ML and blockchain to create a safer food supply chain and oversaw the creation of new pilot programs to use AI/ML technology for food safety monitoring at the border. She also oversaw the agency’s significant civil and criminal enforcement actions, in coordination with the Department of Justice, and advised on all of the agency’s novel or significant compliance activities. With her depth of experience across government agencies, she provides clients with an insider’s perspective on regulatory and compliance issues, enforcement actions, and litigation challenges. Stacy received her JD from Harvard Law School.
JOHN CLAUD is Counsel at Hyman, Phelps & McNamara, P.C. Mr. Claud counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. He also advises clients on matters related to compliance with the Controlled Substances Act and DEA regulations, and matters involving drug compounding, telehealth, and telemedicine. Formerly an Assistant Director at the Consumer Protection Branch of the US Department of Justice, John has litigated several matters involving violations of the Food, Drug and Cosmetic Act as well as Title 18 criminal offenses relating to food safety, compounding pharmacies, telemedicine fraud, and prescription drug smuggling. He started his legal career as an Assistant District Attorney in the Manhattan DA’s Office. John received his JD cum laude from the Catholic University of America Columbus School of Law, has a master’s degree in Criminal Justice from the University of Colorado, and is a graduate of Trinity College in Hartford.
BRIAN P. SYLVESTER is currently Special Counsel at the international law firm of Covington & Burling LLP. At Covington, Mr. Sylvester advises food, dietary supplement, cosmetic, and OTC drug clients on a broad range of regulatory, legislative, and compliance issues before FDA, USDA and analogous food and drug regulatory bodies. His practice additionally encompasses veterinary pharmaceuticals and biological products, animal feed, and pet food. Drawing on his tenure as a regulatory lawyer with USDA, Mr. Sylvester has particular experience counseling clients on strategic considerations around engagement with and advocacy before USDA and FDA on a range of complex issues, including those of first impression. He is a prolific author and frequent speaker at industry-leading events in the US and around the world, and is regularly called upon to offer insights on trending legal issues by publications such as The Wall Street Journal, Forbes, and Food Navigator-USA, among others.
JAE KIM is an associate in DLA Piper’s FDA Regulatory Group, and advises clients in the life sciences, food and beverage, hemp and CBD, and consumer products industries. Jae provides regulatory compliance and risk management advice to companies with products and operations subject to regulation by FDA, USDA, TTB, DEA, and FTC, as well as state regulatory authorities. Her broad regulatory practice encompasses medical devices, drugs (prescription and OTC), dietary supplements, food and beverage, alcohol, hemp and CBD products, tobacco/ENDS, and cosmetics. As part of her regulatory practice, she regularly counsels clients on regulatory issues that arise throughout the product life cycle, including product development and approval strategy, current good manufacturing practices (cGMPs), state and federal licensing and registration, labeling, advertising and promotion, inspections, agreements pertaining to quality and regulatory issues, recall management, and regulatory enforcement actions. Jae has extensive experience in conducting regulatory due diligence on behalf of companies seeking to acquire or invest in companies with a portfolio of regulated products. She also has experience in providing strategic regulatory advice and counseling for companies facing internal investigations, litigation, and arbitrations. Jae serves on the Philadelphia office’s Diversity & Inclusion Committee, and is the co-manager of Cultivate, a DLA Piper blog focused on the hemp and CBD industry. She is also actively involved in the regulatory community, and serves on the Food and Drug Law Institute (FDLI)’s Cannabis Products Committee, as well as the Membership Committee of Women in Bio – Philadelphia Metro chapter.June 13, 2023
4:45–6:30 PM ET
Agenda
4:45-5:00 PM | Check-In
5:00-5:45 PM| Panel Discussion
5:45-6:30 PM | Reception
Registration
This program is exclusively available to FDLI members who are a part of the New to FDA Law & Regulation Group (NFLR), and student members.
APPLY FOR THE GROUP AND REGISTER FOR THE EVENT
New to FDA Law & Regulation Group
NFLR offers young professionals with up to six years of experience an opportunity to connect with colleagues in the food and drug legal and regulatory community, learn from their peers, and enhance their skills. Individuals affiliated with member organizations, those employed by the government, and law students are encouraged to participate.
For questions, please contact Bianca Cardona.
Location
Morrison & Foerster LLP
2100 L Street, NW
Suite 900
Washington, DC 20037
Program Host
