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This profile was last updated on 6/19/11  and contains information from public web pages and contributions from the ZoomInfo community.

Mr. John R. Manthei

Wrong John R. Manthei?

Member of the Advisory Committee ...

Phone: (202) ***-****  
Email: j***@***.com
Local Address:  District of Columbia , United States
The Food and Drug Law Institute
1155 15Th Street, NW, Suite 800
Washington Dc , District of Columbia 20005
United States

Company Description: FDLI is a nonprofit educational organization dedicated to improving the understanding of the laws, regulations and policies affecting food, drugs, medical devices,...   more

Employment History

Board Memberships and Affiliations


  • JD
    University of Wisconsin Law School
  • BA
    Miami University
  • JD
    University of Wisconsin
  • law degree
    University of Wisconsin Law School
81 Total References
Web References
BayBio  | BayBio, 19 June 2011 [cached]
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. His practice focuses on regulatory matters involving the Food and Drug Administration (FDA) for the medical device, pharmaceutical, biotechnology, food and dietary supplement industries. Mr. Manthei's 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. 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), 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.
About FDLI - Committees, 4 Dec 2009 [cached]
John Manthei, Latham & Watkins
Latham & Watkins LLP - About Us - News - Medicis Pharmaceutical Advised in its $2.6 Billion Acquisition by Valeant, 1 June 2014 [cached]
Advice was also provided on antitrust matters by partner Michael Egge with associate Jason Cruise in Washington D.C.: on benefits and compensation matters by partner Jim Barrall in Los Angeles with associate Carol Samaan in Orange County; on litigation matters by partners David Schindler in Los Angeles and Michele Johnson in Orange County; on regulatory matters by partner John Manthei with associate Elizabeth Richards in Washington D.C.; on intellectual property matters by partner Judith Hasko in Silicon Valley; on environmental matters by partner Christopher Norton in Orange County; and on tax matters by partner Nicholas DeNovio in Washington D.C.
John R. Manthei
SpeakerBios, 25 Nov 2009 [cached]
John Manthei, Partner Latham & Watkins John Manthei is a partner in the firm's Washington, D.C. office and the global co-chair of the firm's Health Care and Life Sciences Practice. Mr. Manthei's practice focuses on regulatory matters involving the FDA for the medical device, pharmaceutical and biotechnology industries. His practice includes assisting clients with all aspects of the FDA-regulated product life cycle in both the US and the EU. Prior to joining Latham, Mr. Manthei served as Majority Counsel for the US House of Representatives' Committee on Commerce. He also served as the primary congressional staff contact in the House with the FDA Commissioner's Office and Center Directors, in developing FDA policy. Currently, Mr. Manthei serves as outside FDA counsel to MDMA and is a member of the Food & Drug Law Institute's Advisory Committee for Drugs and Biologics. In 2006, Mr. Manthei was named by Washingtonian Magazine one of the top "40 Lawyers under 40."
"There has certainly been consensus among ... [cached]
"There has certainly been consensus among Democrats and Democratic policy-makers that FDA has failed to live up to expectations and hasn't aggressively addressed laws on the books on the pre-market side and post-market side," said John Manthei, a partner at the law firm Latham & Watkins and former majority counsel to the House Energy and Commerce Committee.
"We should fully expect to see a much more aggressive FDA as we move into 2009."
The next Congress will likely look to new device and drug industry user fees as a way to increase FDA funding, Manthei predicted. Democratic lawmakers agree that FDA needs more resources, but given other Obama administration priorities and the huge federal sums already poured into the financial bailout plan, increased FDA appropriations could be hard to come by, he noted.
"There's going to be a lot of competition for those funds, which makes the user fee much more appealing," Manthei said.
But new user fees would face industry opposition, particularly from smaller device companies, noted Manthei, who serves as outside counsel for the Medical Device Manufacturers Association (MDMA).
Manthei also predicted that the aggressive oversight seen in the recent Congress will shift from FDA to industry, with a Democratic Congress uninterested in calling Obama appointees to task.
"I think oversight of FDA is going to come to an immediate halt this January," he said. "This time, industry will be in the congressional crosshairs."
In particular, industry will be scrutinized for its performance on product safety issues, and its willingness to be "forthcoming" with FDA with safety data, Manthei suggested.
Device firms should also expect to see more FDA-related legislation, attorney Manthei said.
"Industry kind of fell within a comfort zone that amendments to the FDA authorizing statute would largely occur about once every five years, in conjunction with the reauthorization of the prescription drug user fee act and the medical device user fee act," he said.
"I would not be surprised for Congressman Waxman to make that a priority, and for that guidance document to potentially be pulled," Manthei said.
Nevertheless, "it's too important of a position, and I would expect the nomination process to happen shortly after the beginning of 2009," Manthei said.
"That obviously is going to eliminate a number of potentially very qualified candidates," Manthei said.
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