John R. Manthei

  • Partner
  • Ejohn.manthei@lw.com
  • 555 Eleventh Street, NW
  • Suite 1000
  • Washington, D.C. 20004-1304
  • USA
  • T +1.202.637.2211
  •  
 

Profile

John Manthei, a partner in the Washington, D.C. office and 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:

  • 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 Drug Enforcement Administration (DEA) export and import requirements

  • Civil and criminal compliance and enforcement

Mr. Manthei has also been involved extensively in Administrative Procedures Act litigation, including successfully challenging the Agency in Sottera/NJOY v. FDA, Commonwealth v. FDA,  Pacira Pharmaceuticals v. FDA, Eagle Pharmaceuticals v. FDA, and Endo/Par Pharmaceuticals v. FDA, as well as successfully intervening to defend FDA actions on behalf of clients in Teva v. FDAWeyth 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). 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 has been recognized as a leading lawyer in Chambers USA (2010-2020), as a Life Sciences Industry Star by LMG Life Sciences (2012-2019), and as a Leading Lawyer in the Healthcare: Life Sciences category by The Legal 500 US (2012-2020). Mr. Manthei was also recently inducted into the The Legal 500 US' Hall of Fame, 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 as a Trailblazer by the National Law Journal (2018). Mr. Manthei 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, 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 NewsWashington Post, CNN, USA Today, CNBCBoston Globe, San Francisco Chronicle, Forbes, Business Week, and other leading national and international business journals on FDA regulatory, enforcement, and policy matters.

Thought Leadership

  • FDA Announces Planned Changes to the 510(k) Premarket Notification Program -  December 03, 2018
  • FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations -  December 21, 2017
  • FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding -  August 09, 2017
  • FDA Works to Increase Competition Under Commissioner’s Drug Competition Action Plan -  June 29, 2017
  • FDA Issues Draft Guidance on Biosimilar Interchangeability -  January 27, 2017
  • President Obama Signs the 21st Century Cures Act Into Law -  December 13, 2016
  • Highlights Of The FDA's Abbreviated New Drug Applications -  October 11, 2016
  • FDA to Regulate E-Cigarettes, Cigars and Other Tobacco Products -  May 17, 2016
  • Amarin Settles Off-Label Promotion Case Against the FDA  -  March 14, 2016
  • Perspective on Ground-Breaking Settlement Between Pacira and the FDA -  February 08, 2016
  • Lessons From Latham & Watkins’ Representation of Pacira Pharmaceuticals in Ground-Breaking Settlement With FDA -  January 05, 2016
  • Biological Products: New FDA Draft Guidance Sheds Light on Reference Product Exclusivity -  August 22, 2014
  • Unapproved New Uses: FDA Revisits Policies on Distributing Scientific Publications -  April 16, 2014
  • Unapproved New Uses: FDA Revisits Policies on Distributing Scientific Publications -  March 18, 2014
  • The Regulation of Follow-on Biologics -  December 10, 2013
  • Preparing For A "New Era of Medical Product Development" -  November 07, 2013
  • Medical Device IDEs: FDA Continues Effort Toward Greater Efficiency and Transparency -  July 17, 2013
  • FDA Issues Draft Guidance on Expedited Review Programs, Including Breakthrough Therapy Designations -  July 15, 2013
  • The Food and Drug Administration Safety and Innovation Act of 2012: Assessing the Impact on the Medical Device Industry -  August 22, 2012
  • The Food and Drug Administration Safety and Innovation Act of 2012 -  August 17, 2012
  • The Food and Drug Administration Safety and Innovation Act of 2012: Assessing the Impact on the Pharmaceutical and Biotechnology Industries -  July 16, 2012
  • FDA Safety and Innovation Act Reauthorization: Impact on the Medical Devices Industry -  July 16, 2012
  • Opening the Door for Generic Biologics: FDA Releases the First Guidance Documents Implementing the Biosimilar Approval Pathway -  March 2, 2012
  • A guide to FDA's draft guidance on 510(k)s -  October 19, 2011
  • Maintaining Eligibility for FDA Small Business Waivers is Not So Simple -  September/October 2011
  • Future Medical Device Regulation in the European Union -  October 2011
  • The Institute of Medicine Recommends FDA Abandon the 510(k) Premarket Clearance Process -  August 23, 2011
  • The Institute of Medicine Recommends FDA Abandon the 510(k) Premarket Clearance Process -  August 2, 2011
  • FDA Moves to Clarify Nanotechnology Guidelines -  June 20, 2011
  • Food Safety in the 21st Century: Strengthening Food Regulation Through Legislative and Administrative Reforms -  April/May 2011
  • Medical Device Reform Is (Almost) Here: FDA Announces Action Items for Improving The Agency’s 510(k) Premarket Clearance Process -  March 9, 2011
  • FDA Announces Actions Designed to Improve the 510(k) Premarket Clearance Process -  January 27, 2011
  • The Changing Regulatory Landscape for In Vitro Diagnostic Medical Devices -  September/October 2010
  • A Brave New World: The U.S. Food and Drug Administration's Newfound Authority for Regulation of Follow-on Biologics -  April 25, 2010
  • What Every Foreign OEM, Importer Should Know -  July/August 2009
  • Not Yet: Patented Risk Evaluation and Mitigation Strategies May Delay (or Tax) Competitors -  June 1, 2009
  • The Web of Clinical Trial Registration Obligations: Have Foreign Clinical Trials Been Caught? -  June 1, 2009
  • Exclusivity Strategies in the United States and European Union -  May 27, 2009
  • What to Think About When Considering an Overseas Clinical Trial Program -  March 12, 2009
  • FDA Issues a Final Guidance on “Good Reprint Practices” -  January 21, 2009
  • FDA Issues Clarification of US Clinical Trials Registry Requirements -  January 8, 2009
  • Looking Abroad: Clinical Drug Trials -  September 2008
  • New FDA Regulation Alters Standards for Foreign Clinical Trials -  May 29, 2008
  • Ask the Expert -  February 25, 2008
  • What You Don't Know Can Hurt You: Understanding the FDA's Foreign Inspection Program -  February 04, 2008
  • Memorandum of Understanding between the US and China Regarding Imported Drugs and Medical Devices -  January 14, 2008
  • Pharmaceutical Provisions of the FDA Amendments Act of 2007 -  October 19, 2007
  • Medical Device Provisions of the FDA Amendments Act of 2007 -  October 10, 2007
  • When No Predicate is Available – De Novo Review of New Medical Devices -  February 19, 2007
  • De novo classification von neuen Medizinprodukten -  February 7, 2007
  • FDA Guidance on Early Stage Drug Development -  March 9, 2006
  • Increased Scrutiny of Investor Communications by Federal Regulators -  January/ February 2006
  • Recent Supreme Court Decision Permits Use of Patented Compounds to Obtain FDA Approvals -  December 9, 2005

Presentations

  • Intellectual Property and Regulatory Issues Facing Biotech Leaders Today -  May 2014
“Brilliant, highly strategic and consistently on schedule with work”
“Has a talent for understanding the nuances of engaging the FDA or policy makers in a constructive rather than confrontational way” 
“Has an almost encyclopedic knowledge of FDA regulations”
“Gets FDA matters resolved quickly as he has the contacts and relationships and really gets the perspective of the government” 
“Extraordinarily knowledgeable, always available, hard-working, and strategic in his thinking”Chambers USA 2010-2020
Bar Qualification
  • District of Columbia
Education
  • JD, University of Wisconsin Law School, 1994
  • BA, Miami University, 1990
Industries
  • Healthcare & Life Sciences
Practices
  • Israel Practice
  • FDA Regulatory