Overview
In 2020, the US government launched a number of drug importation-focused initiatives aimed at addressing high drug costs in the US. In September, as part of its Safe Importation Action Plan, FDA issued a final rule allowing importation of certain prescription drugs from Canada, along with a final guidance for importing prescription drugs originally intended for foreign markets. The Most Favored Nation executive order, released in November, limits the reimbursement rates for CMS to rates paid by other countries. In this webinar, panelists will take stock of the new state of drug importation, especially in light of COVID-19, and its potential impact to the US drug market. The discussion will include an in-depth review of both actions, focusing on the Safe Importation Action Plan and how Canadian regulators and manufacturers have responded, the risks of foreign unapproved drugs, and the potential impact to US pricing, approvals, and innovation.
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Speakers
David Certner, Legislative Counsel and Director, Legislative Policy for Government Affairs, AARP
Jeffrey K. Francer, Senior Vice President and General Counsel, Association for Accessible Medicines and Member, FDLI Board of Directors
Eileen M. McMahon, Senior Partner, Torys LLP
Moderated by Howard R. Sklamberg, Partner, Arnold & Porter LLP
DAVID CERTNER is the Legislative Counsel and Director of Legislative Policy for Government Affairs at AARP. He has been with AARP since 1982, and is a member of AARP’s leadership team. He serves as counsel for the Association’s legislative, regulatory, and policy efforts, as well as for litigation opportunities before the courts. Prior to assuming his current role in 2007, Mr. Certner had served as Director of AARP’s 25 person Federal Affairs shop, where he headed up all federal legislative and regulatory activity. In both roles, Mr. Certner has testified numerous times before both Congress and regulatory bodies, and has made frequent appearances on TV, on radio, as well as in print publications. Mr. Certner also previously served as chairman of the ERISA Advisory Council of the Department of Labor, and was appointed as a delegate to the 1998, 2002, and 2006 National Summits on Retirement Savings. He is currently a member of BNA’s Pension and Benefits Reporter advisory board. Mr. Certner, an attorney, received his law degree from the National Law Center at George Washington University.
EILEEN M. MCMAHON is Chair of Torys’ Regulatory and IP Group. Eileen has over 30 years of experience advising clients in relation to regulated products (medical devices, pharmaceuticals, dietary supplements, cosmetics and food and beverages sector and consumer products sectors) and has been recognized as a leading lawyer in regulatory law, life sciences law and intellectual property law, among other areas. Eileen is the only lawyer to be ranked nationwide in Band 1 in every year since Chambers inaugural ranking of life sciences (2016-2020).
HOWARD R. SKLAMBERG is a partner at Arnold & Porter where he counsels clients on a wide range of compliance and enforcement issues related to US Food and Drug Administration (FDA) regulation and policy. His experience is rooted in a deep understanding of US and foreign food, drug and medical devices law and policy, and is able to 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, Mr. Sklamberg held a variety of roles at the FDA from 2010 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, Mr. Sklamberg was FDA’s top enforcement official. He oversaw the agency’s inspections, enforcement, recalls, and import operations programs. Mr. 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, Mr. Sklamberg served as a prosecutor in the US Attorney’s Office in Washington, DC, and in the Public Integrity Section of the Criminal Division at the Department of Justice.Virtual Learning FAQ
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