John Manthei, Global Chair of the Healthcare & Life Sciences Practice, focuses his practice on regulatory matters involving the US Food and Drug Administration (FDA) for the medical device, pharmaceutical, and biotechnology industries.
John's practice includes assisting clients with all aspects of the FDA-regulated product life cycle, including, among others:
John has also been involved extensively in Administrative Procedure Act litigation, including successfully challenging the Agency in Catalyst Pharmaceuticals v. FDA, Eagle Pharmaceuticals v. FDA, Pacira Pharmaceuticals v. FDA, Endo/Par Pharmaceuticals v. FDA, Genus Medical Technologies v. FDA, Sottera/NJOY v. FDA, Commonwealth v. FDA, and Fontem v. FDA, as well as successfully intervening to defend FDA actions on behalf of clients in Jazz Pharmaceuticals v. FDA, Teva v. FDA, Weyth Pharmaceuticals v. FDA, and Athenex v. FDA.
In addition, John regularly advises investment banks, and private equity funds in life sciences company investments and corporate transactions.
Prior to joining Latham, John served as Majority Counsel for the US House of Representatives’ Committee on Energy and Commerce (1998-2000). He counseled the Full Commerce Committee Chairman; 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, John 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.
John is ranked Band 1 by Chambers USA for Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia. He has been consistently recognized as a leading lawyer in Chambers USA (2008-2024), named a Life Sciences Industry Star by LMG Life Sciences (2012-2024), and a Leading Lawyer in the Healthcare: Life Sciences category by The Legal 500 US (2013-2024). John was also inducted into the “Hall of Fame” by The Legal 500 US, a distinction shared with only four others across all legal practice areas nationwide. In addition, he was named a Life Sciences MVP by Law360 (2016) and recognized as a Trailblazer by the National Law Journal (2018). He has been repeatedly recognized by Washingtonian magazine, including as one of Washington's Best Lawyers. He currently serves as outside FDA counsel to the Medical Device Manufacturers Association (MDMA).
John 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, CLSA, the Food and Drug Law Institute (FDLI), the American Health Lawyers Association (AHLA), GMA, Harvard University, Stanford University, and MIT, among others. He has been quoted in CBS News, The Washington Post, CNN, USA Today, CNBC, The Boston Globe, San Francisco Chronicle, Forbes, and Business Week.
Firm recognized by Law360 for major court victories and high-profile deals in the life sciences sector for the third consecutive year.
Latham lawyers were honored for securing big victories for Avadel Pharmaceuticals and The Trade Desk.
Firm recognized by Law360 for major court victories and high-profile deals.