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.
Mr. Manthei’s practice includes assisting clients with all aspects of the FDA-regulated product life cycle, including, among others:
Mr. Manthei has also been involved extensively in Administrative Procedures 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, and Commonwealth v. FDA, as well as successfully intervening to defend FDA actions on behalf of clients in Teva v. FDA, Weyth Pharmaceuticals v. FDA, and Athenex 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). 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, 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 is ranked Band 1 by Chambers USA 2022 for Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia. He has been consistently recognized as a leading lawyer in Chambers USA (2010-2022), named a Life Sciences Industry Star by LMG Life Sciences (2012-2021), and a Leading Lawyer in the Healthcare: Life Sciences category by The Legal 500 US (2012-2022). Mr. Manthei 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).
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, 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.
Latham litigation team recognized for successful appeal to the 11th Circuit on behalf of Catalyst in dispute with FDA.
Life Sciences Group honored for high-profile matters that set new precedent across legal disciplines.
John Manthei, Global Co-Chair of Healthcare & Life Sciences Practice, recognized for leadership in his field.