FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement – FDA Watch
In this first part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Gabriel Scannapieco, Partner at AGG and Co-chair of the firm’s Life Sciences industry team. Together, they discuss trends in FDA and DOJ enforcement in 2026; how FDA and DOJ have approached the oversight of GLP-1 drugs; DOJ’s non-prosecution agreement resolutions with Alibaba and AUS Merchant Services and what they mean for FDA enforcement; other products drawing attention from FDA and DOJ; recent FDA enforcement actions; what companies should do now and what should they watch for in the second half of the year related to enforcement; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guest
Gabriel Scannapieco
Gabriel Scannapieco is a partner in the Litigation & Dispute Resolution and Healthcare practices and is co-chair of the Life Sciences industry team at Arnall Golden Gregory LLP. He has extensive experience in complex civil and criminal litigation, particularly in healthcare, consumer protection, and white-collar defense. As a former assistant director at the U.S. Department of Justice (DOJ) Consumer Protection Branch, Gabe brings a unique perspective to navigating high-stakes investigations, enforcement actions, and compliance matters.
During his tenure at the DOJ, Gabe personally oversaw and led numerous enforcement actions involving drugs, biologics, medical devices, foods, nutritionals, consumer products, and counterfeit medications, including record-setting resolutions in healthcare fraud and opioid enforcement. His experience spans the False Claims Act; Anti-Kickback Statute; Federal Food, Drug, and Cosmetic Act; Controlled Substances Act; the Consumer Product Safety Act; the Federal Trade Commission (“FTC”) Act; and various fraud, obstruction, and money laundering statutes. He has successfully managed multi-agency investigations involving the FBI, DEA, FDA, and FTC, and U.S. Postal Inspection Service, delivering unparalleled insights into federal enforcement priorities and decision-making processes.
Gabe’s private practice background includes over a decade at an AmLaw firm, where he represented Fortune 500 clients in healthcare litigation, regulatory compliance, and products liability defense. His strategic approach to client advocacy has earned him a reputation as a trusted advisor to corporations and executives navigating complex legal and regulatory landscapes.
Recognized for his thought leadership, Gabe frequently speaks at national conferences on topics including healthcare enforcement trends, digital health regulations, and white-collar crime. He is an active member of the American Bar Association and Food and Drug Law Institute.
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