Conference Notebook: Reporting From FDLI's 2023 Enforcement, Compliance, And Litigation Conference

The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute ("FDLI") took place in Washington this week. There were too many interesting panels and discussions to mention them all, but presentations about DOJ's and FDA's coordination deserve some special mention.

In his conference keynote address, Arun Rao—the Deputy Assistant Attorney General for DOJ's Consumer Protection Branch—provided an overview of DOJ's year in FDA enforcement. This speech is an annual victory lap for CPB's enforcement achievements, and this year included much discussion about the Branch's Voluntary Self Disclosure (VSD) policy. We've blogged on VSDs previously here and here, as the application of the VSD for FDA-regulated industry has been vexing. DOJ has provided few bright lines about when conversations and disclosures to FDA may also satisfy its own VSD requirements. Meeting those requirements might, as Rao said, make the difference between