Overview
November 27, 2023 marks the tenth and final year in the DSCSA implementation plan and deadline to meet several requirements—interoperable exchange, verification, and tracing. This webinar will explore the impact of DSCSA on the drug supply chain and consider challenges and logistics relevant to DSCSA compliance for industry including: exchanging product data while abiding by these requirements, initiating requests for tracing data of suspect products, and opining on what potential enforcement actions might look like. During this webinar, panelists will also share best practices to ensure DSCSA compliance in advance of the upcoming deadline.
Speakers
Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance (HDA)
Eric M. Marshall, Principal, Leavitt Partners, LLC
Maryann Nelson, Regulatory Manager, Cardinal Health, Inc.
Howard R. Sklamberg, Partner, Arnold & Porter
ELIZABETH A. GALLENAGH is the General Counsel and Senior Vice President, Supply Chain Integrity for HDA. She is the organization’s chief in-house attorney and serves as HDA’s primary expert on prescription drug traceability, distributor licensure and tax issues. Since joining HDA in 2003, Ms. Gallenagh led the Alliance’s industry-wide efforts to replace a 50-state patchwork of pedigree laws with one national traceability solution, which became a reality through the enactment of Title II of the Drug Quality and Security Act in November 2013. In 2014, she was honored by the industry with the Distribution Management Award for Industry Leadership, which honors an individual who has exhibited the highest standards of honesty and integrity, working to enhance industry relations and knowledge, as well as supply chain efficiency and security. Ms. Gallenagh holds a JD from the George Mason University School of Law and a BA from The George Washington University.
ERIC MARSHALL is a principal at Leavitt Partners based in Washington, DC where he advises complex health care coalitions on health policy and provides consulting services to drug and device companies. Eric is an industry specialist in the areas of domestic and international supply chain security; drug, device, and diagnostics regulation; and health care compliance. Prior to joining Leavitt Partners, Eric was an associate with the law firm Faegre Baker Daniels, counseling health care and life science clients on regulatory, compliance, and transactional matters. Eric also has experience as counsel to self-funded Taft-Hartley health and welfare funds, particularly with regard to requirements of the Affordable Care Act. Eric graduated Order of the Coif from the University of Minnesota Law School and has a bachelor’s degree in economics and finance from the University of Northern Iowa.
HOWARD R. SKLAMBERG is a partner at Arnold & Porter where he counsels clients on a wide range of compliance and enforcement issues related to U.S. Food and Drug Administration (FDA) regulation and policy. His experience is rooted in a deep understanding of U.S. and foreign food, drug and medical devices law and policy, and can guide domestic and international clients through the regulatory challenges they face. Areas of expertise include inspections and warning letters, investigations, civil and criminal enforcement, medical product applications and clinical research, food and hemp regulation, imports, the development of FDA policy and FDA-related legislation, and business transactions involving FDA-regulated companies. Prior to entering private practice, Sklamberg held a variety of roles at the FDA from2010 to 2017, including Deputy Commissioner for Global Regulatory Operations and Policy; Director of the Office of Compliance, Center for Drug Evaluation and Research; Deputy Associate Commissioner for Regulatory Affairs; and Director in the Office of Enforcement. While at the agency, he directed an office of over 5,000 employees in more than 200 offices, laboratories and import facilities across the United States, Asia, Europe, and Latin America. As Deputy Commissioner, Sklamberg was FDA’s top enforcement official. He oversaw the agency’s inspections, enforcement, recalls, and import operations programs. Sklamberg also led FDA’s international program, including its agreements and cooperation with foreign regulators, harmonization initiatives, and oversight over the global supply chain. He also interacted with and testified before Congress on behalf of the agency, co-led FDA’s implementation of the FDA Food Safety Modernization Act and was the lead official at FDA on a variety of issues including cannabis and hemp, counterfeit drugs, and FDA’s Mutual Recognition Agreement with the European Union. Earlier in his career, Sklamberg served as a prosecutor in the U.S. Attorney’s Office in Washington, D.C., and in the Public Integrity Section of the Criminal Division at the Department of Justice.
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