John R. Manthei is a partner in the Washington, D.C. office of Latham & Watkins and serves as Global Co-Chair and Washington, D.C. Chair of the Healthcare & Life Sciences Practice. His practice focuses on regulatory matters involving the Food and Drug Administration (FDA) for the medical device, pharmaceutical, biotechnology, and dietary supplement industries.
Mr. Manthei’s practice includes assisting clients with all aspects of the FDA-regulated product life cycle, including, among others:
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Pre-market development
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FDA product submissions
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Development of market exclusivity strategies
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Drafting and negotiation of both US and international clinical trial agreements
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FDA and Federal Trade Commission (FTC) regulation of marketing and promotion of products
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Quality System Regulation and Good Manufacturing Practice requirements (including assisting in third-party audits and drafting SOPs)
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FDA inspections
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Recalls
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FDA and Drug Enforcement Administration (DEA) export and import requirements
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Civil and criminal compliance and enforcement
Mr. Manthei has also been involved extensively in Administrative Procedures Act litigation, including successfully challenging the Agency in Sottera/NJOY v. FDA, Commonwealth v. FDA, Pacira v. FDA, and Eagle v. FDA, as well as successfully intervening to defend FDA actions on behalf of clients in Teva v. FDA, and Weyth Pharmaceuticals v. FDA.
Prior to joining Latham, Mr. Manthei served as Majority Counsel for the US House of Representatives’ Committee on Energy and Commerce (1998 – 2000). In this capacity, he counseled the Full Commerce Committee, the Health and Environment, and Oversight and Investigations Subcommittee Chairmen, as well as the House Leadership on matters relating to the FDA and legislation concerning the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and the Controlled Substances Act. Since 2000, Mr. Manthei has represented the pharmaceutical, biotechnology, and medical device industries as counsel in nearly every major FDA legislative initiative. He has also testified before Congress on several occasions involving FDA and DEA regulatory and enforcement matters.
Mr. Manthei serves as outside FDA counsel to the Medical Device Manufacturers Association (MDMA) and as a member of the Food & Drug Law Institute (FDLI) Advisory Committee for Medical Devices. He also previously served as a member of FDLI’s Advisory Committee for Drugs and Biologics. Mr. Manthei’s life sciences practice has been recognized by numerous publications, including being repeatedly highlighted in Chambers USA (2010 – 2018). He has been named a Leading Lawyer by The Legal 500 US (2012 – 2018), and was recently inducted into their "Hall of Fame," a distinction shared with only four individuals across all legal practice areas nationwide in its Healthcare: Life Sciences category. He was also named a Trailblazer by The National Law Journal (NLJ) in its annual report highlighting lawyers who have “achieved remarkable successes” in their field of work (2018). In addition, he has been recognized as one of five Life Sciences MVPs by Law360 (2016), repeatedly recognized as one of Washington's Best Lawyers by Washingtonian magazine (2013), a Life Sciences Industry Star by Euromoney and LMG Life Sciences (2012 – 2017), one of the Top 40 Lawyers Under 40 by Washingtonian magazine (2006), and in Who’s Who in America, Who’s Who in American Law, Who’s Who International, and Who’s Who Legal: Lifesciences.
Mr. Manthei has authored numerous articles and has been a featured speaker and lecturer on FDA regulatory and enforcement matters at events sponsored by the Pharmaceutical Research and Manufacturers Association (PhRMA), the Biotechnology Industry Organization (BIO), AdvaMed, MDMA, BioCom, BayBio, the Food and Drug Law Institute (FDLI), the American Health Lawyers Association (AHLA), GMA, Harvard University, Stanford University, and MIT, among others. Mr. Manthei also serves on the editorial boards of BNA’s Medical Device Law & Industry Report and LifeSciencesLaw 360.
In addition, Mr. Manthei has been quoted in CBS News, Washington Post, CNN, USA Today, CNBC, Boston Globe, San Francisco Chronicle, Forbes, Business Week, and other leading national and international business journals on FDA regulatory, enforcement, and policy matters.