Food and Drug Law Institute (FDLI) Enforcement, Litigation and Compliance Conference
Washington, DC 20001
Event summary
This annual event brings together industry, regulators, attorneys, litigators, academics, consultants and other stakeholders to discuss trends and issues in enforcement and compliance. Hear from and interact with top officials from the Food and Drug Administration (FDA), Department of Justice (DOJ), Federal Trade Commission (FTC) and other government agencies, and gain valuable insights into the latest developments in civil and criminal litigation, recent cases and settlements.
Featured agenda item
Thursday, December 4, 2025 | 11:20 am – 12:20 pm
Recalibrating Criminal Liability: Enforcement Trends Under the Strict Liability EO
Cooley partner Sonia Nath is co-leading a panel focusing on the recent executive order and DOJ memos addressing concerns about the scope of criminal liability under federal regulations, including strict liability offenses under the Federal Food, Drug, and Cosmetic Act (FDCA). It will examine how the administration’s approach to these regulatory crimes may influence FDCA enforcement and add scrutiny to the Responsible Corporate Officer (RCO) Doctrine. The panel will also include a discussion of the recent Magellan pleas and the pending sentencing of executives in Boston, illustrating the RCO Doctrine in action and evolving landscape of criminal prosecutions in the pharmaceutical sector.
Other members of Cooley’s life sciences and healthcare regulatory team will also attend the conference.
Related contacts
This content is provided for general informational purposes only, and your access or use of the content does not create an attorney-client relationship between you or your organization and Cooley LLP, Cooley (UK) LLP, or any other affiliated practice or entity (collectively referred to as "Cooley"). By accessing this content, you agree that the information provided does not constitute legal or other professional advice. This content is not a substitute for obtaining legal advice from a qualified attorney licensed in your jurisdiction, and you should not act or refrain from acting based on this content. This content may be changed without notice. It is not guaranteed to be complete, correct or up to date, and it may not reflect the most current legal developments. Prior results do not guarantee a similar outcome. Do not send any confidential information to Cooley, as we do not have any duty to keep any information you provide to us confidential. When advising companies, our attorney-client relationship is with the company, not with any individual. This content may have been generated with the assistance of artificial intelligence (Al) in accordance with our Al Principles, may be considered Attorney Advertising and is subject to our legal notices.