FDLI Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries

The annual Enforcement, Litigation, and Compliance Conference brought together industry regulators, attorneys, litigators, academics, and consultants to discuss trends and issues in enforcement and compliance, the latest developments in both civil and criminal litigation, and recent cases and settlements. This year’s conference offered an opportunity to hear from and interact with top officials from FDA, DOJ, FTC, and other government agencies.

Featured agenda items

Thursday, December 8 | 9:05 am

DOJ, FDA, and Compliance in Criminal Violations of the FDCA (Oh My!)

Cooley Partner Sonia Nath moderated this session.

Recently, DOJ announced the establishment of a dedicated group of attorneys who would be monitoring compliance with commitments made as part of Deferred Prosecution Agreements and Non-Prosecution Agreements. This new approach raises interesting questions about the roles of DOJ and FDA in reviewing and making determinations about compliance in the criminal arena, which also carry implications for FDA’s civil enforcement activities such as permanent injunctions and seizure actions that result in court-ordered resolutions. The panel took a closer look at these compliance provisions, and the cases that underpinned them, to better understand the implications of these requirements, as well as how DOJ and FDA work together in these matters.

For more information, please email Yena Lee.