Photograph of John Fuson

John Fuson

Partner


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 assists drug manufacturers with 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)

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"FDA Enforcement and Regulatory Trends: What’s Ahead in 2022?," Crowell & Moring Webinar, 2022. (May 10, 2022). Speakers: John Fuson and Nicholas J. Diamond.
Speech/Presentation
"3D Printing At The Point Of Care: Compliance And Liability Concerns," OC Lawyer (May 2022). Authors: Hilary Johnson, and John Fuson.
Publication
Life After COVID – What Is Next For Medical Device Companies? Med-Tech News (March 17, 2022)
Press Coverage
"Transitioning from the Public Health Emergency into a Post-Pandemic World," State of the Nation 2022: Product Recall (February 25, 2022). Authors: John Fuson and Andrew Kaplan.
Publication
3D printing devices on site: healthcare hero or hazard? Medical Technology (February 22, 2022)
Press Coverage
"Torts & Product Liability Issues," Crowell & Moring's Supply Chain Webinar Series (January 12, 2022). Speakers: Rebecca Baden Chaney, John Fuson, Cheryl A. Falvey, Warren Lehrenbaum, and Carolyn W. Wagner.
Speech/Presentation
"FDA Solicits Input on Regulatory Approach to 3D Printing of Medical Devices at the Point of Care," Mass Tort, Product, and Consumer Litigation Alert (December 13, 2021). Contacts: John Fuson, Hilary Johnson
Client Alert / Newsletter
DEAL NOTE: Crowell & Moring Advises Marshall Wace on Series D Investment in InBrace (September 15, 2021)
Firm News / Announcement
Pfizer’s Newest Vaccine Plant Has Persistent Mold Issues, History of Recalls Kaiser Health News (March 10, 2021)
Press Coverage
"FDA and the Response to COVID: Lessons Learned, and Where the Agency Goes From Here," Healthcare Ounce of Prevention Seminar (HOOPS) 2021: Health Care in the Biden Era (February 23, 2021). Presenters: John Fuson, Chalana N. Damron, and Nicholas J. Diamond.
Speech/Presentation

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Crowell & Moring LLP is an international law firm with offices in the United States, Europe, MENA, and Asia that represents clients in litigation and arbitration, regulatory and policy, and transactional and corporate matters. The firm is internationally recognized for its representation of Fortune 500 companies in high-stakes litigation and government-facing matters, as well as its ongoing commitment to pro bono service and diversity, equity, and inclusion.

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