Overview
This webinar will provide an overview of FDA, DOJ, FTC enforcement authorities as related to the Federal Food, Drug, and Cosmetic Act. Speakers will also address how these agencies work together to pursue criminal or civil remedies. The speakers will explain how the DOJ’s Consumer Protection Branch (CPB) works closely with FDA to investigate and prosecute a wide range of criminal and civil matters involving adulterated and misbranded products. Speakers will also discuss the FTC’s collaboration with these agencies in preventing fraud and explore recent joint enforcement actions by the agencies.
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Speakers
John Claud, Assistant Director, Department of Justice
Christine Lee DeLorme, Attorney, Division of Advertising Practices, Federal Trade Commission
Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius LLP
Moderated by Peter J. Leininger, Partner, King & Spalding LLP
JOHN CLAUD is Assistant Director at the Consumer Protection Branch of the US Department of Justice. John has litigated several matters involving violations of the Food, Drug and Cosmetic Act as well as Title 18 criminal offenses relating to food safety, compounding pharmacies, telemedicine fraud, and prescription drug smuggling. He has also investigated and litigated a broad range of consumer fraud for DOJ, including cases relating to telemarketing, mortgage fraud, and business opportunity fraud. Before joining DOJ, John was an associate in the Washington office of a large national law firm. He started his legal career as an Assistant District Attorney in the Manhattan DA’s Office. John received his JD cum laude from the Catholic University of America Columbus School of Law, has a master’s degree in Criminal Justice from the University of Colorado, and is a graduate of Trinity College in Hartford.
CHRISTINE LEE DELORME is an attorney in the FTC Division of Advertising Practices, where her work focuses on investigating health-related advertising claims. Christine previously served as attorney advisor to FTC Commissioner Rebecca Kelly Slaughter, former Commissioner Terrell McSweeny, and former Chairman Jon Leibowitz, advising the Commissioners on a wide range of consumer protection issues including advertising, privacy and data security, and financial fraud. Before joining the FTC in 2004, Christine was a trial attorney with the National Criminal Enforcement Section of the US Department of Justice Antitrust Division. Ms. DeLorme received an AB in History and a BS in Biology from Stanford University in 1996 and a JD from Harvard Law School in 2000.
PETER J. LEININGER is a member of King & Spalding’s FDA & Life Sciences Practice in Washington, D.C. He represents medical device, pharmaceutical, and biotech companies in FDA regulatory and enforcement matters, including civil and criminal government investigations. From 2012-2017, Mr. Leininger served as an Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel. Pete’s enforcement practice at FDA covered the range of FDA-regulated products, often focusing on product quality, GMP/QSR compliance, MDR reporting, and promotional activity. He frequently handled criminal investigations arising out of qui tam lawsuits filed against drug and medical device manufacturers under the False Claims Act.
KATHLEEN M. SANZO is a partner at Morgan, Lewis & Bockius LLP. As the FDA practice leader, Kathleen represents clients in the pharmaceuticals and biotechnology, food and dietary supplements, consumer products, consumer protection safety, advertising, cosmetics, drugs, and medical industries. Kathleen advises companies on regulatory pathway strategies, appropriate responses to FDA protocols and complete response letters, dispute resolution, responding to Current Good Manufacturing Practice (cGMP) issues, including 483s and Warning Letters, as well as day to day counseling on marketing and promotion launch and other communications, including responses to FDA Untitled and Warning Letters; and similar advice and counsel on food, dietary supplements, and cosmetic products, including various notices and registrations to FDA; recalls and other crisis management; and counseling on product testing, Section 15(b) notices and penalty investigations, as well as product recalls. A frequent author and co-author on publications related to FDA matters, Kathleen regularly speaks on these issues at industry events. Industry and legal groups have praised her work: Legal Media Group Life Sciences named her the “US Regulatory Attorney of the Year,” “FDA Pharmaceutical Industry Lawyer of the Year,” and a “Life Sciences Star.” Chambers USA have listed her in “America’s Leading Lawyers for Business.” She serves as vice-chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice. Kathleen is also a member of FDLI’s 2021 Medical Products Committee.Virtual Learning FAQ
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