Service to FDLI Award
The Service to FDLI Award, established in 2017, honors members who have provided exceptional volunteer services to FDLI. The Award’s criteria centers on a long-standing history of quality contributions to FDLI.
The Award is distinct from the Distinguished Service and Leadership Awards which recognize outstanding leadership in the food and drug law community.
SANDRA COHEN KALTER is Vice President and Chief Regulatory Counsel at Medtronic, where she is responsible for managing legal support for regulatory, quality, medical safety, clinical, advertising and promotion, environmental health and safety and health care regulation. Ms. Kalter has spoken and participated on numerous FDLI committees and programs on regulatory law. She is a past member of the Board of the Food and Drug Law Institute. Ms. Kalter serves as Co-Chair of AdvaMed’s Advertising and Promotion Working Group and is a member of AdvaMed’s Legal Committee and a prior member of AdvaMed’s Case for Quality Working Group. She was humbled to receive Medtronic’s Wallin Award in 2010, one of the company’s most prestigious awards given to leaders. She also served on the Juvenile Diabetes Research Foundation Board and as Corporate Recruitment Chair of the National Capital JDRF chapter. 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 practiced law at Weil, Gotshal & Manges in Washington, DC, specializing in 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.
STUART M. PAPE is senior partner and chair of the FDA practice at Polsinelli. He helps clients understand and face challenges presented by regulations imposed by the US Food and Drug Administration (FDA), US Department of Agriculture (USDA), and similar health and safety regulatory bodies worldwide. He focuses on assisting clients in obtaining approval of new food ingredients, pharmaceuticals, and medical devices; advising on labeling and advertising of regulated products; assisting in enforcement proceedings initiated by regulatory bodies; helping clients develop sound strategies in the face of challenges from NGOs; and lobbying in connection with legislative consideration of statutory changes to the laws governing FDA regulated products. Regularly appearing before the FDA, USDA, the Federal Trade Commission, Consumer Product Safety Commission, US Customs and Border Protection, numerous other federal and state regulatory bodies, and the Congress of the United States, Stuart serves clients across the US in many capacities. Previously, he served in various positions in the Office of the Chief of Counsel at the FDA, including as associate chief counsel for food. In 1978, he received the FDA Commendable Service Award. He also served as executive assistant to FDA Commissioner Donald Kennedy. Stuart is ranked in Chambers USA: America’s Leading Lawyers in Business, Food and Beverages: Regulatory and Litigation; Selected for in inclusion in Super Lawyers; included in The Best Lawyers in America, FDA and in Who’s Who in America and Who’s Who in the World. In 2012, he received the Judge Learned Hand Award from the American Jewish Committee. Stuart is a 1970 graduate of the University of Virginia and a 1973 graduate of its Law School.
AUGUST T. HORVATH, a partner and co-chair of Foley Hoag’s Advertising & Marketing practice, counsels clients on how to substantiate and defend marketing claims they wish to make for their products and services, helps them challenge false and disparaging advertising by their competitors, and assists them in managing relationships with competitors, customers and suppliers without running afoul of antitrust laws. He guides clients through private false advertising and deceptive practices litigation before the Federal Trade Commission, state Attorneys General and the National Advertising Division of the Council of Better Business Bureaus, and litigates in courts across the country. His Ph.D. and experience in survey research and statistical analysis gives him exceptional insight into developing substantiation protocols, designing and assessing research into the implied meaning of advertising claims, and working with and against expert witnesses. Recognized companies in the pharmaceutical, food, beverage, retailing, Internet services, sporting and other consumer goods industries have benefited from his counsel. He earned his law degree from Harvard Law School, his Ph.D. in communication theory and research from the University of Southern California, and a B.A. from the University of Windsor.
RALPH HALL is a principal and works in association with the Washington, DC, office of Leavitt Partners. In this role, Ralph provides consulting services to clients in the areas of FDA statutes and regulations, regulatory compliance, as well as health care policy and legislation, and particularly the application of those regulatory systems to the medical device industry. Ralph’s rich background with drug and medical device regulation and corporate compliance matters makes him one of the nation’s foremost experts. Ralph previously served as counsel at Faegre Baker Daniels where he provided legal services, including FDA-related matters, corporate compliance, the design and implementation of multiple cross-disciplinary, corporate legal strategies, corporate law department organization and management, and general corporate counseling. Ralph has also served as General Counsel for Guidant CRM and Chief Compliance Officer for Guidant. Ralph furthermore serves as a Professor of Practice at the University of Minnesota Law School. He received his BA from Indiana University and his juris doctorate from the University of Michigan where he was a Weymouth Kirkland Scholar.