John W.M. Claud Counsel
John W.M. Claud
Practice Areas
Industries
FDA Regulatory Categories

Overview

Mr. Claud counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. He also advises clients on matters related to compliance with the Controlled Substances Act and DEA regulations, and matters involving drug compounding, telehealth, and telemedicine.

Mr. Claud is a 15-year veteran of the Department of Justice. Prior to joining Hyman Phelps, he most recently served as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit. Mr. Claud has prosecuted and supervised complex criminal and civil trial litigation and investigations under the Food, Drug and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act, and Federal data privacy laws. He also held leading roles in DOJ’s response to three recent and significant national health crises, including the COVID -19 pandemic. Mr. Claud is also an accomplished trial lawyer, having started his career as an Assistant District Attorney in Manhattan before joining DOJ. He is a frequent public speaker on matters of government enforcement strategies under the FDCA as well as corporate compliance best practices.

Education & Admissions

Education

  • J.D, Catholic University of America Columbus School of Law, cum laude
  • Master of Criminal Justice, University of Colorado, Graduate School of Public Affairs, Honored as Outstanding Student of Criminal Justice Program
  • B.A, Trinity College

Admissions

District of Columbia

Experience

Governmental Policy and Leadership

  • Supervised the Consumer Protection Branch’s Corporate Compliance and Policy Unit
  • Directed DOJ’s national oversight of FDCA criminal cases, including the national enforcement response to FDCA violations related to the COVID pandemic
  • Directed DOJ’s criminal investigative response to the 2019 EVALI vaping crisis

Recent Enforcement Litigation and Trial Work

  • Co-lead counsel and then supervisor of investigation and subsequent indictment in ground-breaking, $900 million telemedicine prescription drug fraud scheme. Oversaw investigation, indictments, plea agreements, and trials of pharmacy owners, telemarketers and other co-conspirators, and associated corporate defendants, which resulted in numerous individual and organizational convictions.
  • Supervised negotiated resolution of permanent injunction and consent decree of pharmaceutical manufacturer accused of introducing misbranded and adulterated drugs into interstate commerce.
  • Member of investigative and trial team in the prosecution stemming from 2012 national meningitis outbreak caused by adulterated drugs produced at a Massachusetts compounding pharmacy that resulted in 100-plus deaths and hundreds of infections nationwide. Co-counsel during 10-week jury trial of the lead defendant, which resulted in convictions on 57 felony counts, including Racketeering and Mail Fraud.
  • Lead counsel in investigation, indictment, and prosecution of counterfeit prescription drug smuggling ring, resulting in numerous convictions.
  • Co-lead counsel in criminal jury trial conviction of defendants operating foreclosure rescue fraud scheme.
  • Co-lead counsel in criminal jury trial conviction of defendant operating nationwide business opportunity fraud scheme and subsequent appeal.

Honors & Awards

  • National Health Care Anti-Fraud Association Investigation of the Year
    2022
  • Department of Justice Civil Division Special Commendation
    2020
  • Executive Office of United States Attorneys Director’s Award
    2020
  • FDA Special Citation
    2020
  • National Health Care Anti-Fraud Association Investigation of the Year Award – Honorable Mention for work on prosecutions relating to the 2012 fungal meningitis outbreak
    2019

Speaking Engagements

  • Speaker, ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products, MoCRA is Here – Now What? Adapting to the New Regulatory Framework and Addressing Implementation Challenges, March 20-21, 2024
  • Co-Speaker, ACI’s Forum on Defending FDA-Regulated Consumer Products Class Actions, Tactical Tools for Class Action Prevention: How Proper Claims Substantiation and Sound Labeling Practices Are Sometimes Your Best Offense, October 16-17, 2023
  • Co-Presenter,  FDANews Webinar: Medical Device Enforcement: Are You Up-to-Date on the Latest Developments?, April 20, 2023
  • Panelist, 2022 Informa Connect Hub and Specialty Pharmacy Models West Conference – Telehealth Flexibility and HIPAA Enforcement Updates: Best Practices Intersecting with Privacy, Cyber Security, and EHR Incentive Programs
  • Featured Speaker, 2022 Informa Connect Pharmaceutical Compliance Conference – Current Trends in Compliance
  • Panelist, 2022 FDLI Summer Learning Series webinar – Essentials of FDA, DOJ, FTC Enforcement Authorities
  • Panelist, 2021 FDLI Advertising and Promotion for Medical Products Conference – Inter-Agency Enforcement Updates and Priorities
  • Panelist, 2021 FDLI Digital Health Technology and Regulation Conference – Enforcement Trends and Risks for Digital Health Products
  • Panelist, 2021 FDLI Enforcement, Litigation and Compliance Conference – The Aftermath of AMG: The Future of FTC Actions and Impact on FDA Enforcement
  • Panelist, 2021 American Conference Institute Advanced Summit on Food Law – The Politics and Policy of Food: What Can the Food Industry Expect Under a Biden Administration?
  • Presenter, 2021 Knowledge Group CLE – How to Effectively Handle Government Investigations
  • Panelist, 2020 FDLI Cannabis Regulation Conference
  • Featured Speaker, 2020 InformaConnect Compounding Pharmacy Compliance Conference
  • Panelist, 2020 FDLI Advertising and Promotion Conference
  • Panelist, 2019 FDLI Food Safety and Enforcement Conference
  • Panelist, 2019 PCF Annual Pharmaceutical and Medical Device Compliance Congress
  • Panelist, 2019 FDLI Annual Conference
  • Panelist, 2019 FDLI Food Safety and Enforcement Conference
  • Panelist, 2018 DOJ National Health Care Fraud and Opioid Training Conference
  • Featured Speaker, 2018 CBI Compounding Pharmacy Compliance Conference
  • Panelist, 2018 FDLI Drug Quality Security Act Conference
Education
  • J.D, Catholic University of America Columbus School of Law, cum laude
  • Master of Criminal Justice, University of Colorado, Graduate School of Public Affairs, Honored as Outstanding Student of Criminal Justice Program
  • B.A, Trinity College
Admissions

District of Columbia

Practice Areas
Industries
FDA Regulatory Categories