John R. Manthei
Partner, Latham & Watkins
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. Department Chair of the Healthcare and Life Sciences Practice.
practice focuses on regulatory matters involving the Food and Drug Administration
(FDA) for the medical device, pharmaceutical, biotechnology, food and dietary supplement industries.
practice includes assisting clients with all aspects of the FDA-regulated product life cycle, including, among others: pre-market development; FDA
product submissions; development of market exclusivity strategies; drafting and negotiation of both US and international clinical trial agreements; FDA and Federal Trade Commission (FTC) regulation of marketing and promotion of products; Quality System Regulation and Good Manufacturing Practice requirements (including assisting in third-party audits and drafting SOPs); FDA inspections; recalls; FDA and DEA export and import requirements; and civil and criminal compliance and enforcement.
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 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.
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), is a member of the Food & Drug Law Institute's Advisory Committee for Drugs and Biologics.
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.