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 Sotttera/NJOY v. FDA, Commonwealth v. FDA and Pacira 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 – 2017), a distinction shared with only 13 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.
Some of Mr. Manthei’s recent publications include:
- “FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations,” Latham & Watkins Client Alert (December 2017)
- “FCA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding,” Latham & Watkins Client Alert (August 2017)
- “FDA Works to Increase Competition Under Commissioner's Drug Competition Action Plan,” Latham & Watkins Client Alert (June 2017)
- “The Regulation of Follow-On Biologics: FDA Authority and Implementation,” FDLI Publications (January 2014)
- “Off Label Promotion: New FDA Standards and Guidance,” Medical Devices Law & Industry Report, Bloomberg News (April 2014)
- “The Food and Drug Administration Safety and Innovation Act of 2012: Assessing the Impact on the Pharmaceutical and Biotechnology Industries,” BNA’s Pharmaceutical Law and Industry Report (August 2012)
- “The Food and Drug Administration Safety and Innovation Act of 2012: Assessing the Impact on the Medical Device Industry,” BNA’s Medical Device Law and Industry Report (August 2012)
- “Maintaining Eligibility for FDA Small Business Waivers Is Not So Simple: Practical Considerations for Structuring Investments in Emerging Pharmaceutical Companies in Light of SBA’s Restrictive Policies,” FDLI Update (September/October 2011)
- “Medical Device Reform is (Almost) Here: FDA Announces Action Items for Improving the Agency’s 510(k) Premarket Clearance Process,” Medical Devices Law & Industry Report (March 2011)
- “A Brave New World: The U.S. Food and Drug Administration's Newfound Authority for Regulation of Follow-on Biologics,” Bloomberg Law Reports (May 2010)
- “What to Think About When Considering an Overseas Clinical Trial Program,” BioWorld Perspectives (March 2009)
- “Exclusivity Strategies in the United States and European Union,” FDLI Update (May 2009)