FDLI Announces the 2014 Distinguished Service and Leadership Award Winners

WASHINGTON, Dec. 4, 2014 /PRNewswire-USNewswire/ -- The Food and Drug Law (FDLI) founded in 1949 is a non-profit organization dedicated to providing an innovative, open, balanced exchange of ideas and viewpoints across the field of food and drug law. FDLI's mission is to provide topical and timely education, training, and publications, foster professional relationships, and to act as a liaison to inform public policy, law, and regulation.

Every year FDLI honors four outstanding leaders in the food and drug law community with its Distinguished Service and Leadership Award. The recipients are:

• Elizabeth (Betsy) Anderson, Executive Vice President-Legal and General Counsel, Personal Care Products Council (PCPC).
• William K. Hubbard, Independent Consultant and former Senior Associate Commissioner, The Food and Drug Administration (FDA)
• Leslie Kux, Associate Commissioner for Policy and Director of the Office of Policy, Office of the Commissioner, FDA
• Peter Safir, Partner and Co-Chairman of the Food and Drug practice group at Covington & Burling LLP.

The four recipients will receive their awards at FDLI's Annual Holiday and Leadership Awards Reception.  The awards recognize individuals for their notable service and leadership.

ELIZABETH (BETSY) ANDERSON is Executive Vice President-Legal and General Counsel for the Personal Care Products Council (PCPC). She is responsible for handling legal and regulatory issues facing the industry. Ms. Anderson also serves as PCPC's staff liaison to the Legal Executive Committee, the group responsible for guiding PCPC policy in the legal and regulatory areas.  She has served as a member of the Editorial Advisory Board of the Food and Drug Law Journal and co-authored "The Cosmetics Regulatory Process" chapter in another publication by The Food and Drug Law Institute (FDLI).   She currently serves as Immediate Past Chair of FDLI's Board of Directors.  Before joining PCPC, Ms. Anderson was responsible for the legal and regulatory affairs of Beiersdorf, Inc., a manufacturer of over-the-counter (OTC) drugs, medical devices and cosmetics in Norwalk, Connecticut. Ms. Anderson graduated with honors from Bowdoin College and received her law degree from Boston College Law School. Fluent in German, she spent two years at the Institute of European Studies in Vienna, Austria. 

WILLIAM K. HUBBARD advised the commissioner of FDA on agency policy, coordinated the development of the agency's rulemaking, directed the agency's congressional relations and legislative activities, and oversaw the agency's planning and evaluation functions.  Mr. Hubbard has been a leader of many of FDA's most significant advances of the past 20 years, including legislation to speed the review of new drugs and medical devices, design of the Nutrition Facts and Drug Facts labels on all packaged foods and over-the-counter drugs, the Presidential Food Safety Initiative of 1995-2000, reform of inspection procedures for food production and for imported food, the Bioterrorism Act of 2002, and a major initiative to combat counterfeit drugs. He is the recipient of numerous awards for his service.  Mr. Hubbard began his career in federal service in the U.S. House of Representatives in 1972. He served as a higher education specialist at the Department of Education from 1973 to 1978. After one year at the Environmental Protection Agency, he joined FDA in 1979. Since that time, Mr. Hubbard has worked in FDA's Office of the Commissioner in various capacities (with the exception of a year as an aide to the Secretary of Health and Human Services during the Reagan administration). From 1991 to 1999, he held the position of associate commissioner for policy coordination, and assumed his position as senior associate commissioner in 1999. He received his bachelor of art degree in history and American studies from the University of North Carolina, Chapel Hill, and masters of art degree in public administration from American University.

LESLIE KUX, Esq. is Associate Commissioner for Policy and Director of the Office of Policy in the Office of the Commissioner at the Food and Drug Administration (FDA).  Ms. Kux advises the Commissioner and FDA leadership on a broad range of agency policy issues, as well as regulations and guidance development. She is FDA's focal point for developing cross-cutting agency policy and the agency's liaison for intergovernmental policy development. She oversees, directs, and coordinates the agency's rule making activities and regulations development system, including processing documents for publication in the Federal Register and initiating new systems and procedures to make the agency's rule making process more efficient.   Ms. Kux received her law degree in 1986 from the George Washington University Law School. Before joining FDA, Ms. Kux practiced food and drug law in private practice. She started her career with FDA in 1988 in the Office of Chief Counsel. During her tenure in OCC, she handled litigation and counseling matters on a wide range of issues, including devices, food safety and labeling, veterinary products, imports, and international trade. From 2006 - 2010, she was Deputy Director of the Office of Compliance and Biologics Quality in FDA's Center for Biologics Evaluation and Research.  

PETER O. SAFIR is a partner and co-chairman of the Food and Drug practice group at Covington & Burling LLP.  Mr. Safir has been practicing in the food and drug field for over 25 years and is widely recognized in the pharmaceutical industry as one of the leading food and drug regulatory lawyers in the country.  In recent years, Mr. Safir has worked primarily with the research-based pharmaceutical industry concentrating on marketing practices, life cycle management, and issues involving drug quality and manufacturing.  Mr. Safir has conducted numerous internal investigations for pharmaceutical and medical device companies involving fraud and abuse, advertising, and promotional practices.  He has defended enforcement actions in the marketing and manufacturing areas representing both companies and corporate executives targeted by the FDA. Mr. Safir has published and spoken widely in the area of drug regulation and has been a Professorial Lecturer in Food and Drug Law at George Washington University Law School since 1991.  Mr. Safir is a graduate of Princeton University and the Yale Law School.

This awards reception is held in conjunction with FDLI's Enforcement, Litigation and Compliance Conference which will take place December 8-9, 2014.  Speakers will discuss compliance and enforcement basics surrounding food, drugs, medical devices and tobacco products. Speakers will explore enforcement issues in advertising and promotion, The Food Safety Modernization Act (FSMA), trends in domestic and international markets, data integrity in clinical trials and counterfeit goods.   Thomas South, Special Agent in Charge of Investigative Operations, Office of Criminal Investigations, FDA will deliver the conference's keynote address. Additionally, participants will hear from Mark S. Brown, Partner, King & Spalding LLP. Mr. Brown will deliver the second annual Eric M. Blumberg Memorial Lecture.

Media: For more information, contact Ellen Galant, [email protected], (202) 371-1420. Visit FDLI website at www.fdli.org.

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SOURCE Food and Drug Law Institute

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