John Fuson

,
 Partner Washington, D.C.
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. Before joining Crowell & Moring, John served as associate chief counsel at the FDA, with broad law enforcement responsibilities. While at FDA, John handled all types of 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.

John’s practice at Crowell spans all industries regulated by the FDA and he regularly counsels clients on their critical interactions with the agency. He advises 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. John understands the importance of a strong, trusted relationship with the FDA, and he works with clients to help them build that.

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 considering not only the regulatory requirements, but also helping 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. John works with clients to help them understand risk in competitive marketing environments as they develop claims on labeling and other materials. He advises them on 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. He helps clients to efficiently and effectively respond to agency concerns raised in inspectional observations, warning letters, and other communications.

Family Smoking Prevention and Tobacco Control Act: John also helps clients understand emerging new obligations under the Family Smoking Prevention and Tobacco Control Act. He counsels clients on this charged and rapidly changing regulatory landscape as FDA works to balance its concerns with new technologies, particularly electronic nicotine delivery systems, and its desire to make available tools that will help individuals to quit smoking conventional cigarettes.

John also has experience with animal food and veterinary drug matters. He oversaw various 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.



Affiliations

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



Highlights, News & Knowledge


Speeches & Presentations

  • "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.
  • "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.
  • "FDA Inspection and Enforcement Trends," ABA Section of Litigation Food & Supplements Seventh Annual Workshop, Hershey, PA (June 13, 2017). Panelist: John Fuson.
  • "GMO Labeling: Analysis of the New Law and Strategies for Practical Implementation," ACI Food Law and Regulation Forum, Chicago, IL (May 24, 2017). Presenter: John Fuson
  • "Center for Food Safety and Applied Nutrition (CFSAN)," FDLI Annual Conference, Washington, D.C. (May 4, 2017). Panelist: John Fuson
  • "The Safety Agencies in Transition – What to Expect at FDA, CPSC, and NHTSA in the First 100 Days," Crowell & Moring Webinar (March 30, 2017). Presenters: Cheryl A. Falvey, John Fuson, Matthew Cohen, Scott L. Winkelman, Lauren Bell, Daniel T. Campbell, and Rebecca Baden Chaney.
  • "New & Evolving IP Changes Impacting the Landscape," Maximizing the Value of Intellectual Property and Strategic Collaborations, Rockville, MD (February 7, 2017). Presenters: John Fuson and Terry Rea.
  • "Under the Watchful Eye of the FDA: What Do FDA Warning Letters Tell Us?" Third Annual ABA Life Sciences Legal Summit, San Francisco, CA (September 21, 2016). Presenter: John Fuson.
  • "UDI Update," FDLI - Hot Topics in Medical Device Law, Washington, D.C. (March 31, 2016). Presenter: John Fuson.
  • "Food & Beverage Industry: What Will 2016 Bring?" Webinar (February 10, 2016). Presenters: John Fuson, Michelle Gillette, Andrew Kaplan, and Chalana N. Williams.
  • "Regulatory Considerations in the Medical Device Litigation Discovery Process," Exponent Webinar (November 12, 2013). Presenter: John Fuson.
  • "How Internal Policies & Practices Can Prevent - or Fuel - a Crisis: Managing a Product Recall Crisis," Crowell & Moring Advertising Product Risk Management Seminar (March 19, 2013). Moderator: Laura Jastrem Walther; Panelists: Daniel T. Campbell, John Fuson, and Steve Edwards (Stericycle).
  • "Navigating High-Profile Litigation and Administrative Enforcement," Crowell & Moring Advertising and Product Risk Management Seminar (March 19, 2013). Moderator: Andrew Kaplan; Panelists: Kevin C. Mayer, Keith J. Harrison, and John Fuson.
  • "Consumer Protection and What Obama's 2nd Term Means to Your Business (Including Advertising; Data/Privacy Protection; Product Safety & More)," Association of Corporate Counsel San Francisco Bay Area Chapter, San Francisco and Palo Alto, CA (February 12-13, 2013). Presenters: Bridget E. Calhoun; Christopher A. Cole; Cheryl A. Falvey; John Fuson.
  • "Failure Analysis, Product Recalls, and Liability Preventative Measures to Help Prevent the FDA from Knocking on Your Door," Exponent and Crowell & Moring, Menlo Park, CA (January 29, 2013). Presenters: Kevin C. Mayer and John Fuson.


Publications



Client Alerts & Newsletters



In the News



Firm News & Announcements

Jan.13.2015 Crowell & Moring Releases Third Annual Litigation Forecast Report and Inaugural Regulatory Forecast
May.30.2012 Former FDA Official John Fuson Joins Crowell & Moring