Overview
On October 24, 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act was signed into law. This legislation provides FDA and DEA, as well as several other agencies, with significant new authority to combat the opioid crisis. Join our expert FDA and private practice speakers to understand the tools the legislation provides to FDA and DEA, other efforts FDA is making to combat the opioid crisis, real-world impacts of the legislation, and whether more federal action is necessary to alleviate the high rates of opioid overdoses and deaths in the US.
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Speakers
John Gilbert, Director, Hyman, Phelps & McNamara, PC
Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP
J. Patrick Raulerson, Senior Regulatory Counsel, Office of Regulatory Policy, Center for Drug Evaluation and Research, FDA
Moderated by Jeffrey Francer, Senior Vice President & General Counsel, Association for Accessible Medicines
Jeff Francer is Senior Vice President and General Counsel of the Association for Accessible Medicines, where he leads legal and international trade advocacy.
Patrick Raulerson has been with FDA for 9 years, focusing on regulation of opioids, biosimilars, combination products, and medical gases. He has been part of FDA’s efforts to work with Congress on several major pieces of legislation including The SUPPORT Act, The 21st Century Cures Act, and FDASIA. Patrick has been particularly involved with FDA’s efforts to incentivize and appropriately regulate abuse-deterrent formulations of opioids and safety-enhancing packaging and disposal technologies for drugs of abuse. He has also helped develop and implement FDA’s approach towards the labeling and nonproprietary naming of biosimilar products. 
John A. Gilbert, Jr. is a Director at the law firm of Hyman, Phelps & McNamara, P.C. in Washington, DC. The firm advises and represents a broad range of clients on legal issues concerning food, drug, medical devices, biologicals, pharmacy and cosmetic law and regulation. Mr. Gilbert has advised clients extensively on legal and regulatory issues concerning controlled substances, prescription drugs and precursor chemicals. He advises on federal and state laws and regulations governing the scheduling, manufacturing, distribution, dispensing, import and export of prescription drugs, controlled substances and regulated chemicals. He has represented clients before the Drug Enforcement Administration (DEA) and handled numerous litigation matters involving civil and administrative actions related to violations of the federal Controlled Substances Act (CSA) and state laws. Mr. Gilbert also has extensive experience in scheduling and regulation of controlled substances under the international drug control treaties and issues related to the United Nations Drug Control Program. He has also advised and represented clients on matters related to the World Health Organization’s Expert Committee on Drug Control. Prior to joining the firm in 1995, Mr. Gilbert was an attorney in the DEA’s Office of Chief Counsel, Diversion/Regulatory Section. He also served as a law clerk in the DEA Office of Administrative Law Judges as part of the Department of Justice Honor’s Program. He is admitted to practice law in the District of Columbia and Virginia, and is a member of the American Bar Association and of the Administrative Law and Health Law sections of the Virginia State Bar. Mr. Gilbert received a BA in Political Science from Westfield State College and his law degree from the Catholic University of America, where he was an associate editor of the Catholic University Law Review.
Chad Landmon is a partner at Axinn, Veltrop & Harkrider LLP, where he chairs the FDA and IP Practice Groups. Mr. Landmon has extensive experience in food and drug law and patent litigation and counseling. FDA matters involve client counseling and petitioning FDA and litigating issues relating to the Biologics Price Competition and Innovation Act (BPCIA), including the requirements for the demonstration of biosimilarity and the patent resolution provisions, and the Hatch-Waxman Act, including marketing exclusivities, patent listing, certification and notification requirements, bioequivalence, labeling and other issues. His patent litigation practice is national in scope and concentrates on the life sciences industry. He has litigated a wide variety of FDA and Paragraph IV cases in numerous jurisdictions, including cases involving blockbuster drugs. Mr. Landmon’s practice also includes matters involving the intersection of the antitrust and patent laws, such as issues arising from the settlement of patent and Hatch-Waxman exclusivity disputes. Virtual Learning FAQ
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