Photograph of John Fuson Download V-card

John Fuson

Partner

jfuson@crowell.com
Phone: +1 202.624.2910
1001 Pennsylvania Avenue NW
Washington, DC 20004-2595

John Fuson is a partner in the firm's Health Care, Product Risk Management (PRM), and White Collar and Regulatory Enforcement groups, focusing on U.S. Food and Drug Administration (FDA) enforcement and counseling matters. 

John’s FDA counseling is informed by his role as associate chief counsel at the FDA, prior to joining Crowell & Moring. In this position, he had broad law enforcement responsibilities, handling major enforcement actions brought by the agency, including seizure actions, injunction actions, actions for civil money penalties, and contempt actions. His cases involved drugs, devices, food, and veterinary drugs.

Building on his FDA experience, John is able to offer clients invaluable perspective on FDA matters. He has an insider’s understanding of how the agency thinks, applying its public health focus to his client’s needs regarding product risks and benefits.  John also understands the importance of having a strong, trusted relationship with the FDA, and he works with clients to help them develop that. He regularly counsels clients on their critical interactions with the agency, including advising on product approval strategies, reporting obligations, manufacturing practice compliance, labeling concerns, and product recalls. Clients also turn to John for help with answering  agency inquiries, handling facility inspections, and responding to observations and warning letters. 

Building on his FDA experience, John works primarily with clients in the food, medical device and pharmaceutical industries. He also provides clients in the electronic nicotine delivery industry regulatory guidance related to the Family Smoking Prevention and Tobacco Control Act.

Food Industry: John helps food industry clients navigate new obligations under the Food Safety Modernization Act, handle the burdens of preventive control inspections, evaluate safety risks, and manage product recalls. He also counsels clients on food labeling questions. In these matters, he considers not only the regulatory requirements, but also helps clients balance competitive marketing claims and the threat of false advertising litigation.

Medical Device Manufacturers: John helps medical device manufacturers understand their pathways to market, particularly as FDA seeks to open access to new digital technologies. As they develop claims on labeling and other materials, John helps clients understand risk in competitive marketing environments, including safety concerns, reporting obligations, and Quality System Regulation compliance.

Drug Manufacturers: John provides drug manufacturers on compliance and enforcement matters, focusing on FDA inspections, current good manufacturing practice (GMP) requirements, and data integrity responsibilities. When clients receive inspectional observations, warning letters, and other communications, he helps clients efficiently and effectively respond to agency concerns.

Family Smoking Prevention and Tobacco Control Act: John counsels clients on emerging obligations under the Family Smoking Prevention and Tobacco Control Act, particularly as they relate to FDA’s attempts to balance concerns with electronic nicotine delivery systems and its desire to make tools available to help individuals quit smoking conventional cigarettes.

Animal Food and Veterinary Drugs: While at FDA, John oversaw injunction actions against dairy farms for improper use of new animal drugs and failure to control medicated livestock, oversaw a mass seizure of adulterated pet food from a dirty warehouse, and worked with agency experts to develop an enforcement strategy against distributors of unlawfully compounded new animal drugs. Today, he advises clients on a range of product labeling, content, and manufacturing issues.

John was born in Ohio and grew up in Southern California. He received his B.A. from Grinnell College in Iowa and received his J.D. from the University of Pennsylvania Law School. After law school, he clerked for Judge Marsha S. Berzon on the U.S. Court of Appeals for the Ninth Circuit and now lives with his family in Washington, D.C.

Education

  • Grinnell College, B.A. history (1993)
  • University of Pennsylvania Law School, J.D. (2000)

Affiliations

Admitted to practice: District of Columbia, California (inactive)

View More

"Supreme Court Decision Raises New Questions on Impossibility Preemption in Cases Challenging Sufficiency of Drug Label Warnings," Mass Tort, Product, and Consumer Litigation Alert (June 7, 2019). Contacts: Andrew D. Kaplan, John Fuson, Robbie Rogart, Skyler R. Peacock
Client Alert/Newsletter
"There May Be Hope for That Label Claim, After All: FDA Proposes to Add Additional Non-Digestible Carbs to the Definition of Dietary Fiber," Mass Tort, Product, and Consumer Litigation Alert (April 2, 2019). Contacts: John Fuson, Chalana Netasha Damron
Client Alert/Newsletter
"Cataclysmic Change or Business as Usual: Product Regulation in the Trump Administration," Product Liability Advisory Council Webinar (October 25, 2018). Speakers: Cheryl A. Falvey, John Fuson, and Peter B. Miller.
Speech/Presentation
"FDA Issues New Guidance for the Management of Cybersecurity in Medical Devices," Crowell & Moring's Health Law Blog (October 19, 2018). Authors: Jodi G. Daniel, John Fuson, Brandon C. Ge and Amber Mulcare.
Publication
DOJ Memo Could Offer Additional Defenses In Enforcement Actions MedTech Insight (May 9, 2018)
In the News
DOJ Enforcement Stance Won't Give Companies Free Rein Bloomberg BNA (May 4, 2018)
In the News
"Recent Happenings in Advertising & Product Risk Management – February 2018," Advertising & Product Risk Management Alert (February 26, 2018). Contacts: Helen Osun, Christopher A. Cole, Cheryl A. Falvey, John Fuson, David Ervin, Lauren Aronson, Carolyn W. Wagner, Matthew Cohen
Client Alert/Newsletter
"Recent Happenings in Advertising & Product Risk Management – December 2017," Advertising & Product Risk Management Alert (December 20, 2017). Contacts: Rebecca Baden Chaney, Chalana Netasha Damron, Robbie Rogart, Kate M. Watkins, Rukiya Mohamed, Christopher A. Cole, Cheryl A. Falvey, John Fuson, David Ervin, Lauren Aronson, Carolyn W. Wagner, Matthew Cohen
Client Alert/Newsletter
Protecting Against Individual Prosecutions: Execs Remain A Focus, But There Are Ways To Reduce Risks Medtech Insight (December 13, 2017)
In the News
"Management Oversight and Control: How to Ensure Compliance and Limit Liability," Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries, Washington, D.C. (December 7, 2017). Panelist: John Fuson.
Speech/Presentation

For all Highlights, News & Knowledge, please click here to view desktop bio.

Crowell & Moring LLP is an international law firm with more than 500 lawyers representing clients in litigation and arbitration, regulatory, and transactional matters. The firm is internationally recognized for its representation of Fortune 500 companies in high-stakes litigation, as well as its ongoing commitment to pro bono service and diversity. The firm has offices in Washington, DC, New York, Los Angeles, San Francisco, Orange County, London, and Brussels.

View Desktop Site | Mobile Sitemap

Contact | Subscribe | Terms of Use/Privacy Policy | Alumni

© Crowell & Moring LLP 2019
Attorney advertising - prior results do not guarantee a similar outcome.